Regulatory Affairs Specialist Medical Devices
Save this job and keep your search organized
Create a free account to save jobs, create alerts and return to this listing from your dashboard.
Elevate your career as a Regulatory Affairs Specialist with Prollenium in Richmond Hill. This hybrid role involves managing regulatory projects and ensuring compliance for our innovative medical devices and products. This Specialist role reports to the Chief Regulatory, Clinical, and Medical Affairs Officer. You will prepare, review, and maintain crucial regulatory documentation for medical devices, and support submissions to Health Canada and the US FDA. You’ll collaborate with various teams to address regulatory requirements effectively. Key Responsibilities:
- Prepare and maintain regulatory documentation for devices
- Review product changes for regulatory impact
- Support technical files and validation documentation
- Ensure compliance during regulatory audits
- Assist with ARTG applications and inspections
- Bachelor’s degree in Biomedical Engineering or Life Sciences
- Minimum 2–4 years of relevant experience
- Working knowledge of medical device regulations
- Strong attention to detail and writing skills
- Familiarity with ISO 13485 and quality system requirements
-
Richmond Hill, York Region, Canada Prollenium Medical Technologies Inc. Full-time $70,000 - $95,000 ContractElevate your career as a Regulatory Affairs Specialist with Prollenium in Richmond Hill. This hybrid role involves managing regulatory projects and ensuring compliance for our innovative medical devices and products. This Specialist role reports to the Chief Regulatory, Clinical, and Medical Affairs Officer. You will prepare, review, and maintain crucial...
-
Regulatory Affairs Specialist
2 days ago
Richmond Hill, Ontario, Canada Prollenium Medical Technologies Inc. Full-time $60,000 - $70,000 ContractCompany Overview Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium hyaluronic acid (HA) dermal fillers and cosmetic products. We are proud to address all of our client's needs through streamlined innovation. Prollenium is able to ensure a continual flow of creation, unique ideas,...
-
Regulatory Affairs Associate, Medical Device
2 days ago
Brampton, ON, Peel Regional District, ON; Ontario, Canada RXinsider LTD. Full-time €59,000 - €73,000Join Jones Healthcare Group - Where Innovation Meets Purpose! This role helps ensure the safe and compliant delivery of products that customers and patients rely on every day. It protects the integrity of our operations by maintaining critical regulatory licenses, registrations, and submissions that keep our business moving forward. It also reinforces our...
-
Richmond Hill, ON, York Regional Municipality, ON; Ontario, Canada Olympus Corporation Full-time €80,955 - €109,290 TemporaryEvery day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill...
-
International Regulatory Specialist
3 days ago
Richmond Hill, ON, York Regional Municipality, ON; Ontario, Canada Prollenium Medical Technologies Inc. Full-timeProllenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium hyaluronic acid (HA) dermal fillers and cosmetic products. We are proud to address all of our client's needs through streamlined innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady...
-
Regulatory Affairs Specialist
3 days ago
Richmond Hill, ON, York Regional Municipality, ON; Ontario, Canada Prollenium Medical Technologies Inc. Full-timeCompany Overview Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium hyaluronic acid (HA) dermal fillers and cosmetic products. We are proud to address all of our client's needs through streamlined innovation. Prollenium is able to ensure a continual flow of creation, unique...
-
Senior Regulatory Affairs Specialist
4 hours ago
Richmond Hill, Ontario, Canada Olympus Corporation Full-timeWorking Location: Ontario, Ottawa; Ontario, Hamilton; Ontario, Toronto Workplace Flexibility: Hybrid For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere...
-
Global QA
1 day ago
Kitchener, ON, Waterloo Regional Municipality, ON; Ontario, Canada Intellijoint Surgical Inc. Full-time €68,000 - €83,000 TemporaryA fast-growing medical technology company in Kitchener is seeking a Quality Assurance Analyst to manage key Quality Management System processes and support regulatory compliance for innovative products. Ideal candidates should have 3-5 years of relevant experience in a regulated industry with knowledge of medical device standards. This role offers a...
-
Regulatory Affairs Analyst/Specialist
1 day ago
Ottawa, ON, Ottawa Census Division, ON; Ontario, Canada Sanmina Full-time €80,000 - €100,000 TemporarySanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment...
-
Olympus Regulatory Affairs Senior Specialist
9 hours ago
Richmond Hill, Ontario, Canada Olympus Corporation Full-timeBecome a key player at Olympus as a Senior Regulatory Affairs Specialist in a hybrid role across Ontario. Your expertise in regulatory compliance will be essential for product registrations throughout Canada. In this role, you’ll be responsible for managing regulatory requirements and submissions for Olympus Canada Inc. You will serve as a subject matter...
