Why a Great Opportunity
40 year old Canadian Company manufacturing essential biological products for the international diagnostics industry.
Close to 100 employees, big enough to be effective, small enough to be able to recognize and reward individual contributions.
Job Description
Join a rapidly expanding, successful Canadian Biologics developer and manufacturer. Our client supplies the international clinical diagnostic marketplace with biological drugs and Dx testing products, promoting and enhancing human health.
As a Senior Medical Device Regulatory Affairs Associate, you will (1) help both Compliance and QA maintain the QMS, ensuring it meets current ISO 13485 and 9001 standards and (2) be involved in updating and creating new regulatory submissions to Health Canada, the FDA, and the (European) EU Notified Body (MDD to MDR).
ROLE AND RESPONSIBILITIES:
- Help prepare regulatory submissions to Health Canada, the FDA and the EU Notified Body.
- Update EU submissions, especially with respect to the EU-MDD to EU-MDR transition.
- Ensure that the Quality Management System (QMS) meets current regulatory requirements.
- Handle regulatory submissions, correspondence, and change control requests.
- Assist R&D, QC, S&M, and Operations with regulatory support.
- Make sure design and development processes conform to Policies and Procedures.
- Risk management and internal audits.
- Batch product records review.
- Help QC and Manufacturing coordinate product release.
Qualifications
REQUIREMENTS:
- 4 to 6 years in medical device (Class I) regulatory affairs.
- Management experience preferred.
- Very up to date on European, Canadian, US regulatory guidelines.
- KEY: Especially au courant re recent EU changes in MDD, requiring transitioning to MDR.
- Design Dossier and CE Technical File knowledge.
- Excellent MS Office, English communication, interpersonal, team work, attention to detail skills.
