Principal Regulatory Affairs Specialist

Company: EPM Scientific - Phaidon International
Location: Pleasanton
Posted on: November 12, 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. Ensure that details of any new or modified regulations are distributed to appropriate team members.
• 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 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 technical writing skills
• Must be familiar 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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