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 YOU9LL 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
- Bachelors 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
- Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Masters 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.
Apply Now
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The base pay for this position is
$114,000.00 6 $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)
