Regulatory Affairs Manager - Diabetes Care (on-site)

JOB DESCRIPTION

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.

• 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
• 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.

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.

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.

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 scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Experience with post-approval manufacturing and design changes.
• Experience leading or mentoring a team of regulatory affairs professionals.
• Ability to work effectively on cross-functional teams and build strong relationships with key stakeholders.
• Strong attention to detail with a solution-orientated mindset.
• Able to juggle multiple and competing priorities.
• Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.
• Uses in-depth knowledge of business functions and cross group dependencies/ relationships.

The base pay for this position is $114,000.00 - $228,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations DIVISION: ADC Diabetes Care LOCATION: United States > Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: United States > Milpitas : 1820 McCarthy Blvd, United States > Texas > Austin : 12501B Research Boulevard WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT 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 is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.