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

The Opportunity

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.

What You’ll Work On

• Executes and ensures timely product registration and release for distribution.As the Regulatory Affairs functional lead, oversee and optimize processes and team efforts to obtain and maintain product registration/approval, completion of activities to support release authorization and ensure compliant release of product to specified geographies.Drive strategic engagement with regulatory authorities during the development and review process, ensuring clear communication of complex technical concepts and resolutions to regulatory challenges to facilitate understanding and secure submission approval.Coordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. 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.
• Product release process ownership.Develops and refines processes and tools to support efficient and controlled product release.Responsible for developing, maintaining, and ensuring compliance with applicable Corporate and Divisional policies and procedures.
• Product registration, release authorization and release planning.Provide Regulatory input to product lifecycle planning and project strategy based upon regulatory changesMonitor for and guide team in responding to emerging regulatory issues
• Evaluate product issues and develop informed, compliant solutions aligned with the regulatory requirements of the specific geography.
• Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, 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 and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with applicable U.S. Food and Drug Administration (FDA) and international regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains professional and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• 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.

Preferred Qualifications

• 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).