Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)

Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and Basic qualifications: - 7+ years of working directly with engineering teams experience - 5+ years of technical product or program management experience - 5+ years of technical program management working directly with software engineering teams experience - Experience managing programs across cross functional teams, building processes and coordinating release schedules - Experience with regulatory filings and reports or equivalent - Experience that includes strong analytical skills, attention to detail, and effective communication abilities, or experience working with customers with a passion for delivering exceptional service - Experience working on multi-team, cross-disciplinary projects - Experience that includes strong analytical skills, attention to detail, and effective communication abilities - Experience in identifying incomplete or inaccurate data, identifying the root cause and creating/implementing an escalation plan, or experience communicating results to senior leadership - Bachelor’s Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications) - 5 years of experience working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). - 5 years of experience in a regulated industry with experience working with Class II and/or Class III devices. - Knowledge and understanding of guiding principles in device development such as benefit/risk profile, statistical design or drug dose selection - Experience with medical device software requirements. Preferred: - 5+ years of project management disciplines including scope, schedule, budget, quality, along with risk and critical path management experience - Experience managing projects across cross functional teams, building sustainable processes and coordinating release schedules - Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership - Experience working with Data & AI related technologies, including, but not limited to, AI/ML, GenAI, Analytics, Database, and/or Storage - Regulatory Affairs Certification (RAPS) Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company’s reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits . USA, WA, Bellevue - 148,700.00 - 201,200.00 USD annually