Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)

Job DescriptionAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream ofEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degreeA company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by FortuneA company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientistsThis Senior Regulatory Affairs Specialist will work on-site out of our Alameda, CA or Milpitas, CA locations in the Diabetes Care Division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.The OpportunityAs an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence/machine learning technologies is preferred. This role will also be an important resource for the regulatory department to ensure efficient and compliant business processes. This is an exciting opportunity to work in the dynamic and evolving digital health space.What You'll Work OnRepresent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devicesAssess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidanceAssist in SOP development and review in support of "next-gen" product offeringsRevisit and compare regulatory outcomes with initial product concepts to make recommendations on future actionsUnderstand and investigate regulatory history/background of class, disease/therapeutic context in order to assess regulatory implications for approvalAssist in preparation and review of regulatory submission to authoritiesEvaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory actionDevelop and refine design control procedures in collaboration with other stakeholdersUtilize technical regulatory skills to propose strategies on complex issuesEnsure compliance with product post marketing requirementsReview product labeling to ensure compliance with relevant regulatory requirementsIndividual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counselEstablishes and cultivates an extensive network of support to facilitate completion of assignments.Influences middle management on technical or business solutionsRequired QualificationsBachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.Minimum 2 yrs. regulatory experience and/or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs functionPreferred QualificationsAdvanced degree in Engineering, Sciences, or related disciplinePrevious experience with 510k / PMA submissions or class I / II exempt software devicesKnowledge of insulin dosing products and diabetes management solutionsPrevious experience with SaMD, AI/ML, and other digital health technologiesFamiliarity with Predetermined Change Control Plans (PCCPs)Experience with Medical Devices4-6 years' experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related areaAbility to work effectively on cross-functional teamsMust be able to juggle multiple and competing prioritiesStrong written, verbal, presentation, and organizational skillsWorking knowledge of FDA QSRExercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutionsHas a sound knowledge of a variety of alternatives and their impact on the businessThe base pay for this position is $86,700.00 – $173,300.00 In specific locations, the pay range may vary from the range posted.Job Family: Regulatory OperationsDivision: ADC Diabetes CareLocation: United States > Alameda : 2901 Harbor Bay ParkwayAdditional Locations: United States > Milpitas : 1820 McCarthy BlvdWork Shift: StandardTravel: Yes, 10 % of the TimeMedical Surveillance: NoSignificant Work Activities: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott