16 Sep
|
Prollenium Medical Technologies
|
Richmond Hill
16 Sep
Prollenium Medical Technologies
Richmond Hill
Embark on your journey as a Regulatory Affairs Specialist at Prollenium Medical Technologies in Richmond Hill. This hybrid position entails managing regulatory documentation for our premier medical products. Reporting to the Chief Regulatory, Clinical, and Medical Affairs Officer, you'll be responsible for preparing and maintaining essential regulatory submissions and ensuring compliance with Health Canada and US FDA standards.
You will work closely with cross-functional teams to drive effective results and meet project timelines. Key Responsibilities:
- Prepare regulatory documentation for medical devices
- Manage risk documentation and labeling for devices
- Support submissions and registrations for multiple authorities
- Assist in regulatory audits and external inspections
- Maintain equipment technical files and specifications
Requirements:
- Bachelor’s degree in a relevant field
- 2–4 years of experience in Regulatory Affairs
- Solid knowledge of medical regulations
- Excellent organizational and technical writing skills
- Experience in validation and testing documentation
Utilize your skills to support Prollenium in achieving regulatory excellence.
📌 Prollenium Regulatory Affairs Specialist Position (Richmond Hill)
🏢 Prollenium Medical Technologies
📍 Richmond Hill