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Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team! The Sr. Regulatory Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Sr. Regulatory Affairs Specialist will perform regulatory submission/approval activities for all products and ensures compliance with required regulations and established corporate standards.
Your role with the company:
- Preparing documentation for international regulatory registrations
- Preparing technical documentation compliant with regulations
- Defining worldwide regulatory requirements necessary for regulatory approval of products
- Participating on cross-functional teams as regulatory lead
- Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages
- Authoring submissions, researching requirements, setting priorities, and maintaining project schedules
- Providing guidance and oversight to team members related to regulatory compliance
- Act as a Subject Matter Expert (SME) to support internal and external audits
Desired Profile:
- Bachelor’s Degree in Science, Engineering, or other relevant discipline
- Minimum 8 years’ experience in Regulatory Affairs in the medical device industry
- FDA, EU, Health Canada, and international registrations experience
- Working knowledge of quality system regulations and guidelines
- Ability to develop clear, concise, and timely oral and written reports
- Great communication skills with all levels of personnel
- High level of organization and planning skills
- Working knowledge of medical devices, procedures, and terminology
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