Job Profile: Administrative Operations Specialist 3 Job Family: Administrative Operations Time Type: Full time Max Pay – Depends on experience: $75,000.00 USD Annual Apply before 11:59 PM Arizona time the day before the posted End Date. Minimum Qualifications: Bachelor's degree and five (5) years of experience appropriate to the area of assignment/field; OR, Any equivalent combination of experience and/or training from which comparable knowledge, skills and abilities have been achieved. Job Profile Summary: Supports and instructs those served by the department with complex queries, applies specialized knowledge of multiple standards, policies and procedures, and maintains accurate and detailed records. Job Description: Position Salary Range: $57,900 - $75,000 per year; DOE Essential Duties: - Serves as the primary liaison with national subaward grantees for all programmatic federal, state and local compliance issues. - Ensures compliance with federal guidelines regarding member eligibility, including national background checks, citizenship documentation, national sex offender checks, required educational attainment and other service requirements - Takes the lead role in the allocation of program year slots, costs per Member Service Year(MSY), and funding amounts for subawards. - Calculates the slot allocations and pricing for the ASU’s yearly subaward using OnCorps. - Works to create a veteran-military culture across programs at all levels of the organization. - Develops policies, procedures, and protocols for volunteers that foster civic engagement opportunities for veterans and military member and volunteers during and after their term of services. - Tracks all subaward member service hours in compliance with their term of services. - Reviews and approves criteria for member suspension and exits for compelling circumstances. - Serves as the primary interface with Legacy Corps subaward grantees to provide continuous technical assistance. - Ensures timely exits of members and completes file documents in accordance with federal compliance standards. - Completes all on-site annual compliance visits to ensure adherence to federal, state and local policies. This includes desk-tops reviews and writing federal reports in accordance in established time frames. - Conducts training sessions and public presentations on diverse program topics in support of subaward grantees and veteran-military culture. - Produces monthly performance reports of subaward sites (e.g., measurements of year-to-date enrollment of members, training and service member training activities). - Assists in the review of subaward budgets and compiling support documents. - Interprets AmeriCorps Provisions, Regulations, OMB Circulars and other policies and procedures disseminated through AmeriCorps, or ASU and the Watts College. - Assists in writing foundation or government funding proposals/grant applications. - Reviews, approves, and manages subaward programmatic corrective action plans. - Provides programmatic orientation to new subaward grantees. - Seeks out new program partners for expansion including the identification of prospective new subaward grantees. - Completes other duties as assigned specific to the administration of the Legacy Corps for Veterans and Military Families grant. Desired Qualifications: Experience working on AmeriCorps-funded projects; familiarity with the regulatory compliance issues associated with AmeriCorps State & National programs. Experience developing strategies and technical specifications for large federally-funded projects with multiple subaward grantees. Ability to manage large, complex human service projects. Fosters partnerships; develops understanding of needs, issues, problems. Familiarity with the OnCorps software system. Familiarity with AmeriCorps’ eGrants platform. While Legacy Corps is based on the downtown Phoenix campus of ASU, this position is not required to be done from this location and the work can be done remotely if needed. Working Environment: Activities are primarily performed in a regular, climate-controlled office setting subject to extended periods of sitting, standing, walking. Visual acuity and manual dexterity associated with daily use of desktop computer; bending, stooping, reaching and lifting up to 20 pounds. Ability to clearly communicate verbally in English, read, write, see, and hear to perform essential duties. Review of completed tasks; provides and reviews assigned work activities to team members for quality and achievement of set goals. Department Statement: The Center for Local Government Education and Innovation seeks to bring together the top minds and talent in the country to advance innovation and creativity in local governance, leadership and veteran's affairs. Driving Requirement: Driving is not required for this position. Location: Off-Campus: Phoenix Funding: Grant Funded Instructions to Apply: Current employees, student workers seeking staff opportunities, and students applying for student worker positions must apply directly through the Workday Jobs Hub. Please use the link below to log in using single sign-on. https://www.myworkday.com/asu/d/inst/1$9925/9925$20458.htmld To be considered, your application must include all of the following attachments: - Cover letter - Resume or CV Multiple documents may be uploaded in the attachments section. Alternatively, applicants may combine all required materials into a single PDF for submission. Please ensure uploaded documents are clearly labeled and include your name. Please ensure your resume includes all employment information in month and year format, for example 6/04 to 8/14, along with job title, job duties, and employer name for each position. Your resume should clearly demonstrate how your experience and background meet the minimum and desired qualifications for this position. Incomplete applications or missing required materials may not be considered. Important: Do not withdraw your application to make edits. Once an application is withdrawn, it cannot be edited, reactivated, or replaced with a new submission. If you have questions or need assistance, please contact The Office of Human Resources Talent Acquisition before the posting close date. Graduate Assistant, Intern and part-time positions are counted as half time for experience equivalency, meaning one year equals six months of experience. Only electronic applications will be accepted for this position. By submitting an application, you confirm that the information provided is accurate and complete. ASU Statement: Arizona State University is a new model for American higher education, an unprecedented combination of academic excellence, entrepreneurial energy and broad access. This New American University is a single, unified institution comprising four differentiated campuses positively impacting the economic, social, cultural and environmental health of the communities it serves. Its research is inspired by real world application blurring the boundaries that traditionally separate academic disciplines. ASU serves more than 100,000 students in metropolitan Phoenix, Arizona, the nation's fifth largest city. ASU champions inclusive excellence, and welcomes students from all fifty states and more than one hundred nations across the globe. ASU is a tobacco-free university. For details visit https://wellness.asu.edu/explore-wellness/body/alcohol-and-drugs/tobacco All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other basis protected by law. Notice of Availability of the ASU Annual Security and Fire Safety Report: In compliance with federal law, ASU prepares an annual report on campus security and fire safety programs and resources. ASU’s Annual Security and Fire Safety Report is available online at https://www.asu.edu/police/PDFs/ASU-Clery-Report.pdf. You may request a hard copy of the report by contacting the ASU Police Department at 480-965-3456. Relocation Assistance – For information about schools, housing child resources, neighborhoods, hospitals, community events, and taxes, visit https://cfo.asu.edu/az-resources. Employment Verification Statement: ASU conducts pre-employment screening which may include verification of work history, academic credentials, licenses, and certifications. Background Check Statement: ASU conducts pre-employment screening for all positions which includes a criminal background check, verification of work history, academic credentials, licenses, and certifications. Employment is contingent upon successful passing of the background check. Fingerprint Check Statement: This position is considered safety/security sensitive and will include a fingerprint check. Employment is contingent upon successful passing of the fingerprint check.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Product Submissions and Registration Job Category: Professional All Job Posting Locations: Irvine, California, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.  Remote work options may be considered on a case-by-case basis and if approved by the Company. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Senior Regulatory Affairs Program Lead Job summary Under minimal supervision, the Senior Regulatory Affairs Program Lead provides strategic, end‑to‑end regulatory leadership for complex Class III medical device programs, with primary accountability for US PMA pathways, global market access, and lifecycle sustainability. This role serves as a regulatory subject matter expert and program lead, partnering with R&D, Clinical, Quality, Manufacturing, and regional affiliates to define and execute regulatory strategies that protect commercialization timelines and enable global growth. The position is expected to independently lead high‑risk submissions, direct regulatory interactions with Health Authorities, and global audit readiness, while influencing cross‑functional decision‑making and mentoring less‑experienced regulatory professionals. Key responsibilities Regulatory Strategy & Program Leadership Lead the development and execution of regulatory strategies for US and EU Class III neurovascular medical devices, with a focus on liquid embolic technologies. Act as the Regulatory Program Lead for new product development, indication expansions, and complex lifecycle changes, ensuring alignment at critical program decision points. Independently assess regulatory risk, define mitigation strategies, and drive cross-functional alignment. US & Global Submissions Lead and author US PMA submissions—including Panel-Track PMA Supplements, IDE supplements, Q-Submissions, and Annual Reports—while coordinating with cross-functional teams to ensure timely and high-quality submissions. Support and coordinate Health Canada submissions for Class III and IV devices, including full licenses and Special Access Program (SAP) applications. Lead or contribute to China (NMPA) and Japan (PMDA) submissions, collaborating with regional affiliates and local agents. Support regulatory registrations and maintenance activities in the EU (MDR), UK, Australia (TGA), and other global markets. EU MDR & International Regulatory Compliance Lead the preparation, maintenance, and defense of EU MDR Technical Documentation for Class III devices, ensuring compliance with GSPR, clinical evidence, labeling, and declarations of conformity. Ensure alignment with Australian regulatory documentation requirements, including ARTG technical documentation and change notifications. Serve as a regulatory liaison with Notified Bodies, supporting conformity assessments, surveillance, and change management activities. Health Authority & Notified Body Engagement Communicate directly with FDA and Notified Bodies through written correspondence, teleconferences, and in-person meetings. Represent Regulatory Affairs during FDA meetings (Pre-Sub, Day-100, Interactive Review) and Notified Body audits, preparing and defending responses to regulatory questions and deficiencies. Audit & Quality System Support Serve as a Regulatory SME and backroom facilitator for MDSAP audits, leveraging over three years of experience supporting audits across multiple jurisdictions. Provide Regulatory Affairs support during internal and external audits, inspections, and management reviews, partnering with Quality to address observations, nonconformances, and CAPAs related to regulatory processes. Regulatory Operations & Systems Lead regulatory documentation activities within the Windchill PLM environment, managing regulatory data, change control, and submission-related documentation with over four years of experience. Ensure accurate and compliant documentation within regulatory databases and PLM systems to support global submissions and audits. Contribute to the continuous improvement of regulatory processes, templates, and best practices. Leadership & Collaboration Act as a senior Regulatory Affairs representative on cross-functional core teams, providing technical review and mentoring support to junior regulatory staff. Build strong partnerships with regional affiliates to enable efficient global execution. Core competencies - Advanced regulatory strategy development - Executive‑level communication and influence - Cross‑functional leadership in matrix environments - Global regulatory intelligence and compliance - Risk‑based decision making - Strong written and oral communication skills Required qualifications Education - Bachelor’s degree in engineering, life sciences, or related discipline required - Advanced degree (MS, PhD) preferred Experience Minimum 4 years of progressive experience in Medical Device Regulatory Affairs, including direct responsibility for US and EU Class III medical device submissions and technical documentation, with proven ability to develop and execute strategies for new product development projects, and maintain existing products through the assessment of regulatory impact of changes. This includes experience documenting rationales for all required actions. Given the focus of the business unit, hands-on experience with neurovascular devices is required; experience with peripheral and coronary vascular devices is beneficial for broader portfolio support. In addition, direct experience with liquid embolic device technologies, including the preparation of written communications and technical documentation for regulatory authorities is a critical requirement. To meet the responsibilities of the role and work with internal and external stakeholders, strong written and oral communication skills, with a proven ability to collaborate effectively with R&D, Clinical, Commercial, and Supply Chain teams throughout the product development process to market launch are required skills. US and EU Experience Requirements A minimum of 3 years of direct communication with FDA and Notified Bodies via email, phone, and in-person meetings, including preparation and defense of IDE, PMA, and Q-Sub submissions, responses to FDA questions and Additional Information (AI) requests, and participation in both in-person and virtual FDA meetings. Experience with 510(k) and HDE submissions is strongly preferred and will be considered an asset for supporting the broader device portfolio. Global Regulatory Experience Requirements Experience supporting global submissions and regulatory maintenance activities for Health Canada, China NMPA, Japan PMDA, EU MDR, UK, and Australia (TGA/ARTG), including collaboration with local regulatory leads and preparation of required documentation and responses to information requests. Quality and Compliance Experience Requirements Demonstrated experience leading or supporting MDSAP audits as a Regulatory SME, with preference for candidates who have served as audit backroom facilitators across multiple jurisdictions. Language Skills The preferred candidate must be Fluent in English. The ability to speak at least one Asian language (e.g., Mandarin, Hindi, Japanese, Korean) is strongly preferred. Travel: 5–10% (domestic and international) Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. #LI-Remote Required Skills: Preferred Skills: Coaching, Communication, Competitive Landscape Analysis, Compliance Management, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Product Packaging Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Researching, Safety-Oriented, Sustainability, Sustainable Packaging The anticipated base pay range for this position is : $94,000.00 - $151,800.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

• Responsible for management of a specific, highly complex program or group of highly complex programs in a specialty/functional area including scheduling and budgeting activities and works in collaboration with leaders to implement the program's objectives in support of identified goals and the continuous improvement process • Responsible for monitoring the program's effectiveness and mobilizing stakeholders in support of continuous improvement to the program • Leads interdepartmental activities ensuring ongoing effective program operation and/or implementation • Responsible for identifying strategic opportunities to enhance or expand the program, developing plans and presenting proposals to management • Manages the process of executing initiatives essential for the success of the program, including communication with all stakeholders, both internal and external • Oversees and leads teams in support of the program's objectives • This level has wide latitude for independent judgment and decision making in executing on the goals of the program.

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives. Learn about the Danaher Business System which makes everything possible. The Manager, Medical Writing, is responsible for leading and developing the medical writing team for Danaher Diagnostics, overseeing the creation of high-quality clinical and regulatory documents for submission in the US and EU markets. You will manage a team of experienced medical writers, many with clinical backgrounds (MDs), ensuring scientific accuracy, regulatory compliance, and timely delivery of essential documentation to support clinical studies and product registrations. This position within the Clinical Center of Excellence (CCOE) reports to the Senior Director, Clinical Compliance and Medical Writing, and will be fully remote. In this role, you will have the opportunity to: - Lead, mentor, and performance manage a team of Medical Writers, providing guidance on document development, scientific content, and regulatory requirements for both US and EU submissions. - Oversee the planning, writing, editing, and quality control of a wide range of clinical and regulatory documents, including technical documentation for CE-IVDR/MDR, summaries, and responses to notified body questions, but also could include clinical study protocols, clinical study reports (CSRs), Investigator's Brochures (IBs), and similar documentation, as needed by the Clinical Development teams. - Ensure all medical writing activities and documents comply with Good Clinical Practice (GCP), relevant US (e.g., FDA) and EU (e.g., IVDR/MDR, EMA guidelines) regulatory guidelines, ICH guidelines, and company Standard Operating Procedures (SOPs). - Manage medical writing timelines and resources, ensuring timely delivery of high-quality documents to meet clinical study milestones and regulatory submission deadlines in both the US and EU. - Serve as a subject matter expert on medical writing best practices, document standards, for the US and EU. - Collaborate effectively with cross-functional teams including CCOE Clinical Development, Biostatistics, Data Management and Operating Company partners in Regulatory Affairs, Quality Assurance, Medical & Scientific Affairs and R&D to gather necessary input and ensure scientific accuracy and consistency across documents. - Implement continuous improvement to medical writing processes, templates, and standards to improve efficiency, consistency, and quality within the team, leading with DBS and leveraging AI in accordance with company policies. The essential requirements of the job include: - Bachelor’s degree in a scientific, medical, or related field with 7+ years’ experience in medical writing within the pharmaceutical, biotechnology, diagnostics, or medical device industry, with significant experience preparing documents for US and EU regulatory submissions, or a Masters or Doctoral degree (MD, PhD, PharmD) with 4+ years of same experience. - 3+ years direct leadership experience managing a team of medical writers or other scientific/clinical professionals. - Demonstrated expert understanding of medical writing principles, styles, and standards (e.g., ICH guidelines, GCP). - Demonstrated strong knowledge of US FDA and EU regulatory requirements and guidance related to clinical and regulatory documentation (e.g., FDA guidance, IVDR/MDR requirements, EMA guidelines). - Experience working with clinical study data (including statistical output) and interpreting complex scientific and clinical information for inclusion in regulatory documents. - Proven ability to lead and develop a remote team of highly skilled professionals. Travel, Motor Vehicle Record & Physical/Environment Requirements: - Ability to travel <10%, as needed for DBS events and initiatives It would be a plus if you also possess previous experience in: - Previous experience specifically in the diagnostics medical device industry preparing documentation requirements under IVDR. - Experience managing medical writers with advanced clinical degrees (e.g., MDs). - Experience with submission, review and publication of peer-reviewed journal articles. Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Within Danaher Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide. The annual salary range for this role is $130-160k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. #LI-LM3 Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.