Principal Regulatory Affairs Specialist

Title: Principal Regulatory Affairs Specialist
A 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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