Principal Regulatory Affairs Specialist

Company: EPM Scientific - Phaidon International
Location: Pleasanton
Posted on: November 6, 2024

Job Description:

Title: Principal Regulatory Affairs SpecialistA leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products.Responsibilities:

• Developing strategies for regulatory approval on a global scale for new and modified products.
• Prepare regulatory applications for FDA and international agencies.
• Coordinate, compile, and submit regulatory submissions such as EU dossiers, Premarket notifications, PMA supplements, change notifications, etc.
• Maintain annual licenses, registrations, and listing information.
• Act as the subject matter expert (SME) for audits and inspections with internal and external authorities.
• Review and edit Ad Promo material.
• Maintain ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current and up-to-date.
• Support the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.Qualifications:
• Minimum 5+ years of experience with Class II and/or Class III medical devices.
• Experience authoring and submitting 510k applications and PMA supplements.
• RAC Certification.
• Experience 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 technical writing skills.
• Familiarity with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
• Ability to travel 5%, including international travel.
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Keywords: EPM Scientific - Phaidon International, Merced , Principal Regulatory Affairs Specialist, Other , Pleasanton, California