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

JOB DESCRIPTION:

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for 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 - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity working mothers female executives and scientists.

The Opportunity

This Principal Regulatory Affairs Specialist APAC position will work on-site at our Alameda CA location in the Diabetes Care Division. Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were 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 Youll 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 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.

Required Qualifications

• Bachelors 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

• Bachelors 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).

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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