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
- Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems. Ensures that details of any new or modified regulations are distributed to appropriate team members.
- Supports 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
