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Abbott

Makes heart devices, glucose sensors and lab tests

Regulatory Affairs Manager - Diabetes Care

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time$114k - $228k

About the Job

Requirements

  • A Bachelor's degree in a related field or an equivalent combination of education and work experience is required.
  • At least 4 years of experience in a regulated industry, such as medical products or nutritionals, is required; higher education may compensate for years of experience.
  • The ability to communicate verbally and in writing, prepare materials, and negotiate internally and externally with diverse audiences is required.
  • Knowledge of domestic and international regulatory guidelines, policies, and regulations is required.
  • The ability to lead functional groups in developing relevant data to complete a regulatory submission is required.

Responsibilities

  • Drive U.S. regulatory strategy for new products and lifecycle management.
  • Lead and mentor a team of regulatory professionals, fostering collaboration, development, and high performance.
  • Partner with research and development, clinical, quality, and commercial teams to influence product development and ensure regulatory success.
  • Provide strategic guidance on Food and Drug Administration pathways, submissions, and interactions, including pre-submissions, 510(k), premarket approval applications, and post-market activities.
  • Negotiate and interact with regulatory authorities during development and review to ensure timely submission approval.
  • Ensure compliance while balancing speed to market with robust regulatory standards.
  • Anticipate and 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; act independently as a decision-maker on regulatory issues and ensure deadlines are met.
  • Develop, enhance, and streamline regulatory policies, processes, and standard operating procedures; train team members; and evaluate regulatory risks of division policies, processes, and procedures.
  • Monitor evolving regulatory requirements, guidance, and industry trends; interpret their applicability and implement changes to standard operating procedures and submission documentation as required.
  • Comply with applicable corporate and divisional policies and procedures.

Desired Qualifications

  • Two to five years of experience in regulatory affairs is preferred; candidates with experience in quality assurance, research and development or support, scientific affairs, operations, or a related area may also be considered.
  • A Bachelor's degree in science, including biology, chemistry, microbiology, immunology, medical technology, pharmacy, or pharmacology; mathematics; engineering; or a medical field is preferred.
  • A Master's or Ph.D. in a technical area is preferred.
  • Regulatory Affairs Certification from the Regulatory Affairs Professionals Society, or a similar certification, is a plus.
  • Experience with U.S. submissions, including premarket approval applications, supplements, investigational device exemptions, or 510(k) submissions; CE submissions under the European Union Medical Device Regulation; and international submissions is preferred.
  • Experience with Class II and Class III medical devices is preferred.
  • Ability to define regulatory strategy, follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues is preferred.
  • Experience with post-approval manufacturing and design changes is preferred.
  • Experience leading or mentoring a team of regulatory affairs professionals is preferred.
  • Ability to work effectively on cross-functional teams and build strong relationships with key stakeholders is preferred.
  • Attention to detail and a solution-oriented mindset are preferred.
  • Ability to manage multiple and competing priorities is preferred.
  • Experience exercising judgment within broadly defined practices and policies to select methods, techniques, and evaluation criteria for obtaining results is preferred.
  • Broad knowledge of technical alternatives and their potential business impacts is preferred.
  • In-depth knowledge of business functions and cross-group dependencies and relationships is preferred.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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