Senior Regulatory Affairs Specialist - Post Launch

Senior Regulatory Affairs Specialist - Post Launch

• 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.

• 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.)

• 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.

• 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.