Regulatory Affairs Manager - Diabetes Care (on-site)

Abbott; United States; Sur place; USD 120 000 - 150 000; Plein temps

Résumé du poste

Abbott is seeking a Regulatory Affairs Manager to lead U.S. regulatory strategy for the Diabetes Care portfolio, overseeing approval processes for new products and lifecycle changes at onsite locations in Alameda, Milpitas, or Austin.

You will mentor a cross-functional team, collaborate with R&D, quality, and clinical groups, and ensure timely submissions to FDA and other authorities while maintaining regulatory compliance and strategic risk management.

Qualifications

• Bachelor's Degree or equivalent education and work experience.
• Minimum 4 years' experience in a regulated industry; 2-5 years in regulatory preferred.
• Excellent verbal and written communication; able to negotiate with diverse audiences.
• Knowledge of domestic and international regulatory guidelines.
• Experience leading regulatory data for submissions.

Responsabilités

• Drive US regulatory strategy for new products and lifecycle management.
• Lead and mentor a team of regulatory professionals.
• Partner with R&D, clinical, quality, and commercial teams to shape development.
• Provide guidance on FDA pathways, submissions, and post-market activities.
• Ensure compliance excellence and timely regulatory submissions.

Connaissances

Regulatory strategy

Team leadership

Cross-functional collaboration

Communication

Formation

Bachelor's degree

Master's degree or PhD

Description du poste

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At 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
• Employees 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 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

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, 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 position is an onsite opportunity working out of either our Alameda, CA, Milpitas, CA or Austin, TX for our Diabetes Care division.

As a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio.

WHAT YOU'LL DO

• Drive U.S. regulatory strategy for new product and lifecycle management.
• Lead and mentor a team of regulatory professionals, fostering a culture of collaboration, development, and high performance.
• Partner cross-functionally with R&D, clinical, quality, and commercial teams to influence product development and ensure regulatory success.
• Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
• Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.
• Ensure compliance excellence, balancing speed to market with robust regulatory standards.
• Anticipate and effectively communicate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with cross-functional teams.
• Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and assure that deadlines are met.
• Develop, enhance and streamline regulatory policies, processes and SOPs and train team members. Evaluate regulatory risks of division policies, processes, procedures.
• Stay ahead of evolving regulatory requirements, guidance, and industry trends. Interpreting applicability and implementing changes to SOPs and submission documentation as required.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Lead functional groups in the development of relevant data to complete a regulatory submission.

Required Qualifications

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience
• Minimum 4 years' experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
• Domestic and international regulatory guidelines, policies and regulations.
• Lead functional groups in the development of relevant data to complete a regulatory submission.

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Master's or Ph.D. in a technical area.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions.
• Experience with Class II and Class III medical devices.
• Ability to define regulatory strategy. Able to follow scien