One of the world's foremost science and technology companies, Danaher is a global corporation that was founded in 1969 and has been developing, producing, and a
Principal, Regulatory Affairs Specialist
Location
Colorado + 1 moreAll locations: Colorado | New York
Posted
1 day ago
Salary
$110K - $135K / year
Seniority
Entry Level
Job Description
Principal, Regulatory Affairs Specialist
Danaher
Title: Principal, Regulatory Affairs Specialist Location: US, Boulder, New York Job Description: Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Integrated DNA Technologies (IDT), one of Danaher’s 15+ operating companies, our work 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. Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you’ll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all. The Principal Regulatory Affairs Specialist is responsible for developing and executing strategies for global market introduction of new and modified IVD medical devices and software while acting as a SME within the Global Regulatory team and providing mentorship to entry-level and intermediate associates. This position reports to the Manager, Regulatory Affairs and is part of the Regulatory Affairs team located in Boulder, CO and will be fully remote. In this role, you will have the opportunity to: - Author and lead the creation of regulatory documents (regulatory submissions/filings, registration and listing, technical files, etc.) to obtain global approvals to commercially distribute products; collaborates with international colleagues in global regions to submit application/registration documents. - Provide guidance and approve regulatory/quality documentation related to new product development deliverables acting as core team member conducting regulatory assessments related to design changes, advising and approving protocols, reports, marketing material, etc. - Assess risk levels associated with current and emerging regulatory issues, providing guidance to facilitate and ensure practices are consistent with the corporate guidance and SOPs; interpret new and/or existing regulatory requirements ensuring compliance with applicable agency requirements, published standards, local procedures and project specific plans. The essential requirements of the job include: Education, Licensure, Certification, Registration - Bachelor’s degree in a technical field such as chemistry, biochemistry, biology, or related Professional Experience: - Minimum 7 years of experience in regulated environment required; 4+ years of global regulatory experience related to in vitro diagnostics required. - Knowledge and experience in U.S. FDA and EU IVD regulations; with proven experience in submission of PMA, de novo, 510(k) and/or technical files required. - Experience and understanding of product development process inclusive of Design Control and Risk Management; broad knowledge and previous application of ISO 13485, IVDR, and 21 CFR Part 820 required. It would be a plus if you also possess previous experience in: - Strong collaborative facilitation skills with the ability to build consensus while championing global regulatory compliance. - Ability to work independently utilizing developed research and analytical skills to manage multiple projects. - Must be a strong collaborative facilitator and leader, building consensus while championing global regulatory compliance IDT, a Danaher operating company, offers 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. At IDT 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 for IDT can provide. The annual salary range for this role is $110,000 -$135,000. 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 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-LCS 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. 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.
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Regulatory Risk Operations, Derivatives
BinanceThe World’s Leading Blockchain Ecosystem and Digital Asset Exchange
• Analyze regulatory technical standards, design SOPs based on regulatory requirements, and coordinate with key stakeholders. • Provide advice, objective reviews, and challenges to ensure that key operational risks are adequately and effectively identified, assessed, and managed in both business-as-usual activities and new initiatives, products, and processes. • Conduct independent assessments and daily monitoring of operations based on the regulated entity’s rulebooks, assessing whether there are systemic or thematic risk concerns that warrant deeper analysis and escalation to senior management. • Monitor regular operational cycles, validate results, and continuously improve operational processes. • Periodically audit operational results, processes, and public information to identify potential regulatory and compliance risks. • Coordinate with different teams to prepare periodic and ad-hoc notifications to regulators, and maintain accurate records of key decisions and operational outcomes.
Role Description The Vice President (VP), Banking Compliance is a senior leadership role responsible for overseeing and enhancing the Bank’s Compliance Management System (CMS) and compliance operations across deposit operations, commercial and consumer banking, and lending activities. This role serves as a subject matter expert in bank regulatory compliance with a strong focus on: - Deposit and Lending compliance - HMDA - CRA - Fair Lending Ensuring adherence to applicable federal and state laws and regulations, including OCC supervisory expectations. The VP will partner closely with business line leadership, risk management, and audit functions to ensure effective compliance oversight and approvals across the full lifecycle of banking products—from account opening and client onboarding to lending and loan lifecycles, including disclosures, customer communications, and regulatory reporting and analysis. The role plays a critical part in managing compliance risk, supporting regulatory expectations, and promoting a strong culture of compliance across the organization. Duties and Responsibilities - Regulatory Compliance Oversight - Lead second-line oversight of compliance across deposit operations, consumer and commercial banking, and lending activities. - Ensure adherence to key regulations including HMDA, CRA, ECOA/Reg B (Fair Lending), TILA, RESPA, UDAAP, TISA, EFTA, and applicable OCC guidance. - Review and approve customer disclosures and notices, including account opening, maintenance, product changes, and fee schedules. - Oversee development, implementation, and maintenance of compliance policies, procedures, and controls across business lines. - Provide expert guidance on regulatory interpretation, applicability, and implementation. - Prepare executive-level reporting for senior management, Risk Committee, and the Board on compliance trends and risks. - Maintain strong relationships with internal audit, legal, and business partners. - HMDA, CRA, and Fair Lending Leadership - Serve as the Bank’s HMDA and CRA Officer and lead the Bank’s HMDA and CRA Task Forces. - Oversee HMDA data integrity, reporting, and governance, including data validation, scrubbing, and annual LAR submissions. - Lead CRA program oversight, including performance monitoring, assessment area analysis, and regulatory exam readiness. - Direct Fair Lending program activities, including risk assessments, statistical analysis, and monitoring for disparate treatment or impact. - Review findings, root cause analysis, and corrective action plans; ensure timely escalation of material issues. - Partner with internal stakeholders to identify and remediate potential compliance risks. - Deposit Operations and Disclosures Expertise - Provide oversight of compliance risks related to deposit products, account servicing, and customer disclosures. - Ensure compliance with regulatory disclosure requirements and customer communications (e.g., Reg DD, Reg E). - Collaborate with operations and product teams to ensure compliant product design and lifecycle management. - Provide advisory support on new product development, system implementations, and strategic initiatives. - Ensure timely incorporation of regulatory changes into policies, procedures, and controls. - Promote a proactive, risk-aware culture aligned with the Bank’s compliance and risk appetite. Qualifications - 5+ years of progressive experience in banking compliance, risk management, or audit. - Demonstrated expertise in HMDA, CRA, and Fair Lending, including program management and reporting. - Strong experience supporting deposit operations, disclosures, commercial and consumer lending compliance. - Experience interacting with regulators (OCC, FDIC, CFPB or Federal Reserve). - Professional certification such as CRCM (Certified Regulatory Compliance Manager) preferred, but not required. Requirements - Deep understanding of consumer protection regulations (ECOA, TILA, RESPA, UDAAP, Reg DD, Reg E, etc.). - HMDA data collection, validation, and reporting requirements. - CRA performance standards and evaluation criteria. - Fair Lending analytics and risk assessment methodologies. - Familiarity with compliance systems, data analytics tools, and reporting platforms. Leadership Skills - Proven ability to lead cross-functional initiatives and influence senior stakeholders. - Strong analytical, problem-solving, and decision-making skills. - Excellent written and verbal communication skills, including executive-level reporting. Preferred Attributes - Experience in a growth-oriented bank ($1B–$10B range) with evolving regulatory expectations. - Ability to build and enhance compliance programs in a dynamic environment. - Strong balance of strategic oversight and hands-on execution. Work Location Requirement This position is designated as remote; however, if you reside within a 50-mile radius of one of our office locations, the role will be considered in-office and not eligible for remote work. EEO Statement We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Business Integrity Trade Compliance Senior Manager
PwCBuild what’s next — with tech that matters PwC provides professional services across Audit and Assurance, Advisory and Tax — powered by a global network of over 370,000 people in 149 countries. You may know us for our business expertise, but technology is core to how we help clients move faster, build trust and deliver meaningful outcomes. As a technologist, you’ll work on agile teams with experienced engineers and product thinkers — using AI, cloud, cybersecurity and more to design scalable, real-world solutions. You’ll keep learning, stay challenged and be part of a network where your growth is built in — and your work drives what’s next.
The Opportunity As a Business Integrity Trade Compliance Senior Manager, you will focus on maintaining regulatory compliance and managing risks for clients, providing advice and solutions. Within our Internal Firm Services practice, you will confirm adherence to regulatory requirements and mitigate risks for clients, offering guidance on compliance strategies and helping clients navigate complex regulatory landscapes. As a Senior Manager, you will leverage your skills and network to deliver quality results, motivating and coaching others to solve complex problems. You will apply sound judgment, recognizing when to take action and when to escalate, while developing and sustaining high-performing, diverse, and inclusive teams. In this role, you will craft and convey clear, impactful messages that tell a holistic story, applying systems thinking to identify underlying problems and opportunities. You will validate outcomes with clients, share alternative perspectives, and act on client feedback. Your ability to direct the team through complexity, demonstrating composure in challenging situations, will contribute to the success of our firm. This position offers the chance to deepen your skills with a focus on staying relevant, making difficult decisions, and resolving issues hindering team effectiveness. Responsibilities - Leading regulatory compliance initiatives to help clients navigate complex regulatory landscapes - Developing and implementing compliance strategies to mitigate risks effectively - Managing and guiding teams in the execution of compliance audits and risk assessments - Providing strategic advice on regulatory requirements and internal controls - Overseeing the maintenance of compliance programs and frameworks - Collaborating with stakeholders to validate outcomes and incorporate feedback - Directing the team through challenging and uncertain situations with composure - Crafting and conveying clear, impactful messages that tell a holistic story - Initiating open and honest coaching conversations to foster team development - Applying systems thinking to identify underlying problems and opportunities - Making informed decisions to resolve issues hindering team effectiveness - Modeling and reinforcing professional and technical standards and the firm's code of conduct What You Must Have - At least a High School Diploma or the equivalent degree - At least 6 years of experience What Sets You Apart - Demonstrating advanced analytical thinking and data interpretation skills - Utilizing comprehensive knowledge of compliance frameworks and standards - Excelling in regulatory compliance program maintenance and reporting - Leading teams through complex compliance audits and risk assessments - Applying strategic questioning to drive business ethics and governance - Innovating processes for cybersecurity risk management and transaction monitoring - Building relationships to enhance influence and inclusion within diverse teams The salary range for this position is: $91,000 - $321,500. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy. Learn more about how we work: https://pwc.to/how-we-work For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines
Local Trade Compliance Officer
ABBHelping industries outrun with our leading technologies in electrification and automation. go.abb/outrun
• Develop, document, and maintain export control, sanctions, and customs compliance procedures, guidelines, and working instructions. • Perform and manage restricted party screening, embargo checks, and classification of goods, software, and technologies using SAP GTS or manual processes. • Serve as the primary trade compliance advisor, providing policy guidance and practical support for daily import/export operations. • Act as the key trade compliance contact, leading communication platforms, building local capability, and aligning global trade initiatives within the organization. • Ensure compliance with global and local trade regulations by monitoring regulatory changes and communicating updates to stakeholders. • Provide transactional support for import/export activities, including issue resolution, screening findings, and system block releases. • Implement and manage trade compliance training and awareness programs for employees, including role-specific instruction. • Oversee trade compliance processes within business operations, including master data, supplier qualification, and documentation/recordkeeping requirements. • Conduct trade compliance reviews, self-audits, and transactional checks; identify gaps and drive corrective actions. • Maintain compliance with export authorizations and reporting requirements, ensuring accurate classification and adherence to regulatory conditions.




