Regulatory Affairs Manager
4 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Working at AbbottAt 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 of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save (student debt program and FreeU (education benefit - an affordable and convenient path to getting a bachelor's degree.
- A 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 Fortune.
- A 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 scientists.
This Regulatory Affairs Manager Digital Health Technology will work on-site at our Alameda, CA location 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.
This Regulatory Affairs Manager Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment. This position has responsibility for the preparation and submission of product approval applications. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Ensures employee compliance with such policies, practices and procedures and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements.
What You'll Work OnProvides guidance on regulatory requirements and strategies to software product development project teams. Sets strategy and directs preparation of submissions for products to regulatory agencies, to obtain timely approval to produce and market new digital products or release software features. Creates, reviews and approves engineering changes. Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences. Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. Performs related functions and responsibilities, on occasion, as assigned. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand, investigate, and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Determine and communicate submission and approval requirements. Participate in risk benefit analysis for regulatory compliance. Monitor impact of changing regulations on submission strategies.
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Oakland, California, United States Abbott Full timeAbout the RoleAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...
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