Senior Regulatory Affairs Specialist - Post Launch
As a member of our Regulatory Affairs team, you will provide accurate, relevant, and timely information internally and externally, to maintain product regulatory compliance, and to support approval of regulatory submissions for global product markets.
Regulatory Approval Maintenance
- Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed.
- Complete annual review of Health Canada (HC) Medical Device Licenses, HC Medical Device Establishment License, FDA establishment registration, and international registration updates as necessary
- Evaluate impact of changes on regulatory compliance.
- Evaluate temporary deviations and nonconformance reports for Adverse Effects and regulatory compliance.
- Support regulatory and customer audits.
Post Market Surveillance Activities
- Act as Post Market Surveillance (PMS) Agent
- Review Customer Feedback within established timeframes for reportability
- Approve Complaint Closure Reports
- Report trends from product feedback to support continuous improvement, vigilance activities and management reviews.
- Actively participate in Annual Risk Reviews
- Compile PMS Reports and PSURs (Periodic Safety Update Reports)
- Perform appropriate Vigilance Activities (reports, advisory notices, etc.)
Regulatory Research and Guidance
- Research and advise project groups of relevant regulatory requirements that require interpretation and provide guidance on this interpretation throughout the product lifecycle.
- Research regulatory requirements for new potential markets or new market regulatory requirements
- Prepare summary of regulatory requirements changes for management reviews.
- Establish and maintain positive working relationships with external stakeholders.
- Ensure accurate and efficient coordination of the internal process related to the preparation of all materials required in regulatory submissions, inspections, license renewals, and annual registrations.
- Prepare, submit, and track regulatory submissions and assist in gathering information for pending regulatory submissions.
Health and Safety
- Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
- Degree in health or biological sciences, or a related field
- Certificate in Regulatory Affairs or equivalent work experience
- Minimum of 5 years of regulatory experience in a medical device environment
- Developed strategies and documentation to support submissions and approval of medical device applications globally.
- Knowledge and understanding of regulations governing medical devices in Canada, US and Europe is an asset
- Knowledge of the requirements of an ISO 13485 quality program
- Excellent oral and written communication skills, including technical writing.
- Computer literate with:
- Advanced experience in a Windows environment
- Advanced experience in MS Word
- Advanced experience in MS Excel
- Basic knowledge of Enterprise Resource Planning (ERP) software, e.g. Great Plains Dynamics is and asset
- Experience using database software to manage data and records is an asset.
- Strong organizational and general administrative skills
- Demonstrated attention to detail.
- Strong interpersonal skills with ability to communicate effectively with internal personnel and external parties, e.g., customers.