Regulatry Affairs Specialist
Vor 6 Tagen
Are you a seasoned Regulatory Affairs Specialist looking to take the next step in your career within an organization that values innovation and quality? Are you ready to contribute to a rapidly growing spinal implant company and make a real impact by helping bring life-changing products to market? If so, we invite you to join our Regulatory Affairs team and support compliance with local and global regulatory standards
Key Responsibilities:- As a Regulatory Affairs Specialist, you'll be crucial in ensuring our products comply with all applicable regulatory standards.
- Working alongside cross-functional teams, you'll navigate regulatory requirements and contribute to the smooth market entry of our medical devices globally.
- Prepare and maintain documentation for product registrations.
- Keep regulatory databases current.
- Oversee registration lifecycles in our Registration Information Management System.
- Assist in creating and updating MDR Technical Documentation.
- Support 510(k) submissions as needed.
- Collaborate with teams in R&D, marketing, and manufacturing to assess regulatory implications of project changes.
- Communicate with international agents, distributors, and authorities to oversee global product registrations.
- Assist in preparing PMS/PSUR reports for product evaluations.
- Participate in internal and external audits conducted by regulatory authorities.
- Support regulatory assessments for new standards and regulations.
- Collect, analyze, and interpret Regulatory Metrics and Key Performance Indicators.
- At least 3 years of recent experience in Regulatory Affairs.
- Background in the medical device industry, with a solid understanding of Medical Device Regulation.
- Strong communication skills, with the ability to clearly convey information across diverse teams.
- Skilled in technical writing for structured documents, including protocols and reports.
- Capable of compiling, organizing, and maintaining detailed regulatory files.
- Proficiency in both English and French.
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