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Abbott · 1 month ago

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

Alameda, CA

Full-time

Onsite

Senior Level, Lead/Staff

$100K/yr - $200K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Principal Regulatory Affairs Specialist position is responsible for leading strategic planning and developing innovative solutions to ensure timely regulatory registration and release of products for distribution in the Asia Pacific market.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

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

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

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

Qualification

Regulatory submissions21 CFR 820ISO 13485Scientific writingEU Medical Device RegulationVitro Diagnostic RegulationInternational registrationFluency in ChineseLeadershipCommunication skillsTeam collaborationProblem-solving

Required

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

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)