Senior Regulatory Affairs Specialist
$80,955–$109,290 year
HybridOttawa, Ontario, Canada
Job Summary
Oversee regulatory activities for the Olympus Canada Inc. portfolio, including the preparation of submission documents for product registration and the maintenance of product licences throughout their life cycle. Provide guidance to global product RA SMEs on deliverables, assess impacts of changes to Canadian laws, and support regulatory reviews of marketing materials and labelling. Liaise with cross-functional teams to integrate Canadian regulatory requirements into product design controls and maintain regulatory files and databases. Participate in internal and third-party audits, functional improvement projects, and mentoring of junior staff while providing reports on key deliverables to senior management.
Required Qualifications
- BS/BA required preferably in engineering or life sciences, or advanced degree and/or other relative experience
- Minimum of 5 years prior regulatory affairs experience in the medical device industry
- Working knowledge of Canadian medical device regulatory requirements
- Ability to travel up to 10% of time domestically and internationally
Desired Qualifications
- Additional working knowledge of US regulatory requirements
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