Principal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)

Abbott • CA

102d • $98,000 - $196,000

About The Position

This Principal Regulatory Affairs Specialist – APAC position 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 Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.

Requirements

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, Life Sciences, Biology (or equivalent vocational qualifications).
• Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices.
• Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
• Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization.

Nice To Haves

• Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Masters in technical area or MBA; Doctorate in a technical area or law.
• 5+ years’ experience in regulatory affairs.
• Scientific writing experience.
• Solid understanding of the EU Medical Device Regulation (MDR – Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR – Regulation (EU) 2017/746).
• Experience working within an ISO 13485-certified Quality Management System.
• Proven international registration experience, ideally with a focus on Asia Pacific markets.
• Fluency in Chinese is highly desirable.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

Responsibilities

• Executes and ensures timely product registration and release for distribution.
• Oversee and optimize processes and team efforts to obtain and maintain product registration/approval.
• Drive strategic engagement with regulatory authorities during the development and review process.
• Coordinate with cross functional teams to ensure all internal and external requirements are met prior to product release.
• Manage multiple programs independently, identifying risk areas and escalating issues as appropriate.
• Develops and refines processes and tools to support efficient and controlled product release.
• Provide Regulatory input to product lifecycle planning and project strategy based upon regulatory changes.
• Monitor for and guide team in responding to emerging regulatory issues.
• Acts as a liaison with other departments for major initiatives.
• Hires, retains, and develops a diverse, highly qualified staff and provides ongoing performance feedback.
• Maintains a safe and professional work environment.
• Support all Company initiatives as identified by management.

Benefits

• Career development with an international company.
• 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.
• Recognized as a great place to work in dozens of countries.
• Named one of the most admired companies in the world by Fortune.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees