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.
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.
If you interested in this employment opportunity, please apply through LinkedIn At the applicant's request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities. Please send your résumé only once per position. Résumés will be accepted throughout the process, but only candidates selected for interviews will be contacted. TMI is an equal opportunity employer. We thank all applicants in advance for their interest in joining our team.