About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people's lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company's products are sold at key retailers, online and offline, and through distributors around the world. As the Medical Device Complaints Manager, you will lead the design, execution, and continuous improvement of SharkNinja's global medical device complaints and post-market surveillance processes. This role is accountable for ensuring complaints are consistently captured, investigated, trended, and escalated in compliance with global regulatory requirements-while remaining tightly integrated with SharkNinja's customer experience and consumer electronics operating model. You will establish and operate a complaints process that is risk-based, scalable, and audit-ready, aligned to device classification and global market requirements. Partnering closely with Customer Experience, Core Quality, NPD Quality, Engineering, Regulatory, Legal, and Product teams, you will ensure post-market signals are translated into meaningful corrective actions, risk mitigation, and product improvements-supporting both patient safety and rapid innovation at scale. Key Responsibilities - Own and evolve the global medical device complaints and post-market surveillance process, ensuring compliance with 21 CFR Part 820 / FDA QMSR, ISO 13485, EU MDR, and other applicable global requirements. - Design and maintain a risk-based, scalable complaints framework aligned to device classification, product complexity, and SharkNinja's global market footprint. - Oversee complaint intake, triage, investigation, escalation, and closure, ensuring timely, thorough, and compliant handling across all regions. - Lead adverse event assessment and vigilance reporting, including FDA MDRs, EU MDR PMS/Vigilance reporting, and other country-specific submissions as required. - Establish and monitor complaints metrics, trending, and dashboards, identifying systemic issues, emerging risks, and early warning signals. - Ensure complaints data feeds effectively into CAPA, risk management, and product improvement activities, partnering closely with Core Quality, NPD Quality, Engineering, and Product teams. - Coordinate technical investigations and root cause analyses with Core Quality, Engineering, Product Development, and Customer Experience teams. - Lead and support medical device recalls, field actions, and safety communications, and serve as the primary complaints and post-market subject matter expert during audits and regulatory inspections. Qualifications & Experience - Bachelor's or Master's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline. - 7-10+ years of experience in medical device complaints handling, post-market surveillance, vigilance, or quality systems, preferably within consumer electronics, electromechanical devices, or high-velocity product environments. - Demonstrated experience designing, operating, and scaling medical device complaints and post-market processes compliant with 21 CFR Part 820 / FDA QMSR, ISO 13485, and EU MDR. - Strong hands-on experience with complaint investigations, adverse event reporting, vigilance submissions, trending, and CAPA integration. - Experience authoring and maintaining EU MDR post-market documentation, including PMS plans/reports and PSURs (as applicable). - Proven experience supporting or leading medical device recalls and field actions, including cross-functional coordination and regulatory communication. - Strong cross-functional influence and communication skills, with the ability to translate post-market data into actionable quality, product, and risk decisions. - Experience managing or leading complaints or post-market teams. - Pragmatic, risk-based mindset with a proven ability to operationalize post-market compliance in fast-paced, consumer-driven environments. Salary and Other Compensation: The annual salary range for this position is displayed below. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, flexible spending accounts, health savings accounts (HSA) with company contribution, 401(k) retirement plan with matching, employee stock purchase program, life insurance, AD&D, short-term disability insurance, long-term disability insurance, generous paid time off, company holidays, parental leave, identity theft protection, pet insurance, pre-paid legal insurance, back-up child and eldercare days, product discounts, referral bonus program, and more. Pay Range $111,800-$136,600 USD Our Culture At SharkNinja, we don't just raise the bar-we push past it every single day. Our Outrageously Extraordinary mindset drives us to tackle the impossible, push boundaries, and deliver results that others only dream of. If you thrive on breaking out of your swim lane, you'll be right at home. What We Offer We offer competitive health insurance, retirement plans, paid time off, employee stock purchase options, wellness programs, SharkNinja product discounts, and more. We empower your personal and professional growth with high impact Learning Programs featuring bold voices redefining what's possible. When you join, you're not just part of a company-you're part of an outrageously extraordinary community. Together, we won't just launch products-we'll disrupt entire markets. At SharkNinja, Diversity, Equity, and Inclusion are vital to our global success. Valuing each unique voice and blending all of our diverse skills strengthens SharkNinja's innovation every day. We support ALL associates in bringing their authentic selves to work, making an impact, and having the opportunity for career acceleration. With help from our leadership, associates, and our community, we aim to have equity be a key component of the SharkNinja DNA. Learn more about us: Life At SharkNinja Outrageously Extraordinary SharkNinja Candidate Privacy Notice - For candidates based in all regions, please refer to this Candidate Privacy Notice. - For candidates based in China, please refer to this Candidate Privacy Notice. - For candidates based in Vietnam, please refer to this Candidate Privacy Notice. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability, or any other class protected by legislation, and local law. SharkNinja will consider reasonable accommodations consistent with legislation, and local law. If you require a reasonable accommodation to participate in the job application or interview process, please contact SharkNinja People & Culture at accommodations@sharkninja.com

Healthcare Specialist Queens Manhattan Community Program - New York, New York (Hybrid) Position: Healthcare Specialist, Queens-Manhattan Community Program Department: Community Programs Location (s): Manhattan, with frequent travel throughout NYC Reports To: Program Manager Classification: Full Time – Non-Exempt Work Model: Hybrid Compensation: $34.07/hr, non-negotiable # of positions: 1 Who We Are Established by Black and Latina activists in 1984, the Violence Intervention Program (VIP) is NYC’s only culturally specific organization with a mission to address domestic and sexual violence within Latinx communities. We provide intensive support and services to 3500+ survivors and children every year and reach 10,000+ community members through community events and preventive education workshops. We are dedicated to developing innovative programs that meet the complex needs of our diverse community and that align with our organizational values. What We Offer As an organization led by and for people of color and survivors of violence, we are deeply committed to our team’s wellness. We seek to create a supportive environment by offering: unlimited PTO; flexible schedules; a hybrid workplace policy; health benefits coverage up to 90% for staff and their families; 403(b) retirement plans; a staff wellness committee; time to play and laugh together, and much more. We are constantly improving and encourage team members' input to help us shape an affirming and uplifting workplace. A Great Fit. The ideal candidate is passionate about health justice, experienced in healthcare navigation and advocacy, and working with Spanish-speaking communities. The ideal candidate will serve as a critical bridge between the healthcare system and low-income, immigrant Latina survivors who are often isolated due to fear of immigration enforcement, lack of insurance, or language barriers. The ideal candidate demonstrates compassion and sensitivity, provides trauma-informed care, and is excited to work both independently and collaboratively as a strong team player. The Role of Direct Client Services & Advocacy - Conduct initial health needs assessments on all assigned clients and their children to identify immediate health risks (urgent/chronic) and barriers to care (insurance/ID). - Provide intensive healthcare case management services to Latina mothers based on the participant’s needs and service plan. - Provide personal support and accompaniment to families, including translation and physical support for medical appointments, screenings (e.g., mammograms), and urgent care visits, to ensure safety and proper treatment. System Navigation & Partnership Building - Advocate with healthcare providers regarding billing disputes, applications to free or low-cost health care programs, and care management to prevent medical debt and ensure fair treatment. - Develop partnerships with hospitals, community clinics, and other healthcare providers that can provide low-cost/free healthcare to both documented and undocumented folks. - Provide direct referrals to clinics, hospitals, and other healthcare centers to low-income Latina immigrants and their children annually. - Stay abreast of changes in the NYC healthcare landscape, including Medicaid eligibility, sliding-scale resources, and rights regarding medical care for undocumented individuals. Education & Training - Facilitate bilingual workshops (in-person and online) annually to educate community members on preventive care, navigating the healthcare system, and health rights. - Train frontline staff to navigate the healthcare system to better support clients. - Attend and participate in regularly scheduled agency and program meetings, including supervision sessions, trainings, case conferences, and team meetings. Specific Job Requirements - BSW or BA (Social Work, Public Health, or Human Services preferred), or equivalent work experience in the relevant field. - Must be fully Bilingual in English and Spanish – verbal and written. - At least one year of relevant experience in healthcare coordination, medical case management, or social services. - Advocacy and/or counseling experience in the area of domestic violence, women and children’s issues, or related field. - Must be knowledgeable in working with diverse communities, particularly Latine, people of color, and low-income populations, and deliver culturally competent services. - Strong verbal and written communication and documentation - Must have the ability to operate office equipment and possess strong internet and software skills, including. Microsoft Office and client database. - Able and willing to travel frequently within/to all NYC boroughs. Compensation & Benefits - Full-time, non-exempt position, working 35 hours per week with annual wages of $62,000/year. - We cover 85% of the cost of medical, dental and vision coverage for employee and spouse/children/family. Flexible Spending Accounts & Health Savings Accounts available. - Unlimited PTO, 12 paid holidays, a mid-year and end-of-year office closure. - Summer Friday schedule (optional) - Commuter benefits (Mass Transit & Parking) - 403b retirement plan - Employee Assistance Program - Disability & Life Insurance - Monthly health & wellness activities - Team appreciation days Location New York, New York (Hybrid) Department Queens Manhattan Community Program Employment Type Full-Time Compensation $34.07/hr

Role Description As a US Screening Lead, you will be responsible for ensuring all US background checks are completed accurately, efficiently, and in full compliance with client expectations as well as pre-set federal and state guidelines. As the first point of review, the ESL assesses and resolves issues raised by specialists, clients, vendors, or other stakeholders, taking ownership of challenges whenever possible and escalating unresolved matters to the Support Lead and/or US VP of Operations & Compliance when necessary. Duties and Responsibilities - Process and manage high volumes of US background checks, including criminal records, in accordance with established procedures and regulatory compliance. - Develop training material and lead others as they come onto the team to complete checks. - Communicate professionally with internal team members, candidates, and external vendors regarding background check statuses and requirements. - Maintain accurate and organized records of screening activities. - Oversee the day-to-day workflow of the US screening team. - Serve as a subject matter expert for US screening cases, escalating to Support Lead & VP of US Ops/Compliance when needed. - Other tasks as requested. Qualifications - Minimum of 2 years of experience in US background check leadership setting. - Proficient typing skills (approx. 60 WPM). - Demonstrated ability to write clearly, concisely, and professionally. - A proactive and independent work ethic, with a proven ability to manage time effectively. - Strong communication skills with candidates, team members, and vendors. - Quick learner who works well independently and in a fast-paced environment. - Familiarity with U.S. employment laws (FCRA, EEOC, state requirements). - Experience with background check commercial platforms preferred. Requirements - Prior Experience: Must have prior experience and exposure to processing U.S. background checks and have served in a leadership role—including US national/county/federal criminal record searches, motor vehicle reports (MVR), sanctions checks, social media reviews, employment and education verifications, etc. - Availability: Primary requirement is the ability to work in US business hours. - Communication Skills: Excellent verbal and written communication skills are essential for clear and professional report writing and internal documentation. - Subject Matter Knowledge: Deep familiarity with US criminal background checks is required. - Leadership Experience: Openness and readiness to serve in a lead role for the US entity, which includes working independently, team training, and process management.

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description This position will report into the ED, Head of Clinical Operations Compliance. In this role you will be a key member of the Kite Align team and work cross-functionally with the Clinical Development organization at Kite. Kite Align drives process and training alignment across the Kite Clinical Development organization and Gilead. You will partner closely with the Kite Research & Development Quality team and central process teams at Gilead. Key Responsibilities: - Drive the development, optimization, alignment and implementation of clinical trial processes across Kite Clinical Development - Partner with equivalent Gilead functions for development, optimization and alignment of shared clinical trial processes - Identify and Lead Process Improvement opportunities at Kite - Establish and maintain the training curricula for Clinical Operations (inclusive of Clinical Operations, Data Management and Clinical Logistics) and support other Clinical Development functions, as needed - Develop Onboarding plans for Clinical Operations - Support transition planning within Clinical Operations as needed - Proactively monitor compliance with Clinical Operations procedural documents and training requirements - Develop and report process and training compliance metrics - Support and participate in internal audits and regulatory authority inspections as needed - Support audit/inspection response development and CAPA implementation - Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to ensure Clinical Development processes are updated as necessary - Lead and support efforts to increase compliance awareness and a culture of compliance Basic Qualifications: - BS or BA in a relevant scientific discipline and 8+ years of experience OR RN (2 or 3 year certificate) and 8+ years of experience. - Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction. - Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. - Functional expertise to initiate, author, or contribute to SOP development, implementation, and training. - Demonstrated understanding of end-to-end clinical trial processes. Preferred Qualifications: - Strong communication and influence skills and ability to create a clear sense of direction. - Demonstrated ability to lead. - Ability to examine functional issues from a broader organizational perspective. - Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision. The salary range for this position is: $165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma. For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.