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Regulatory Affairs Specialist Heart Failure
2 months ago
We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our Heart Failure Division on-site in Pleasanton, CA.
This is a specialized role that requires expertise in regulatory submissions for medical devices, pharmaceuticals, and in vitro diagnostic devices. The successful candidate will provide support for the regulatory department, ensuring efficient and compliant business processes and environment.
Key Responsibilities- Develop worldwide strategies for regulatory approval of new and modified products.
- Prepare robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives.
- Coordinate, compile, and submit regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
- Represent Regulatory Affairs on cross-functional product development and manufacturing support teams.
- Maintain annual licenses, registrations, and listing information.
- Assist with compliance to product post-marketing approval requirements.
- Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
- Reviews, edits, and approves Advertising and Promotional materials.
- Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies.
- Maintains ongoing surveillance and analysis of all pertinent medical device regulations.
- Bachelor's Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology) or equivalent vocational qualifications.
- Experience in regulatory submissions for medical devices, pharmaceuticals, and in vitro diagnostic devices.
- Knowledge of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).
- Minimum of 5 years of experience working with Class II and/or Class III medical devices.
- Regulatory Affairs Certification (RAC) is a plus.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
We are committed to employee diversity and offer a range of benefits, including career development opportunities, free medical coverage, and a retirement savings plan.
Join us in our mission to make a meaningful difference in the lives of people around the world.
