Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Regulatory Affairs
Salary Type
Annual
Job Description
Regulatory Affairs Specialist
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
Qualifications:
- 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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