The Regulatory Affairs Specialist will support the programs and processes that ensure that DNA Genotek products are in compliance with applicable global medical device and IVD regulatory requirements for currently engaged and target markets.
- Complete updates and annual renewals to medical device registration & licenses including Health Canada Medical Device Establishment Licence and FDA Establishment registration and listing.
- Complete updates to regulatory technical files, declarations of conformity, classification rationales to new EU IVD & medical device regulations.
- Create and maintain classification rationales for all products.
- Assist or lead completion of new global registrations and registration renewals to support strategic objectives.
- Review and approve labeling e.g. labels, blogs, marketing materials.
- Complete regulatory assessments for product or process changes impacting medical devices.
- Update risk management files & reports as needed e.g. for product or process changes of medical devices or addition of new risks.
- Assist in review and approval of product change request.
- Assist in review and approval of customization requirements documents.
- Complete annual product reviews for regulatory compliance.
- Review and approve Device master records, Design history files.
- Assist in review and approval of 510(k) Letter-to-File (Memo to File).
- Support implementation of Unique Device Identifier (UDI) requirement across all products per ISO13485:2016 and EU IVDR / MDR.
- Maintain UDI data entry to FDA GUDID, EU Eudamed & related databases.
- Review complaint assessments to determine per country reportability and impact to current risk assessment.
- Supports Quality Management System processes focused on regulatory compliance.
- Other duties deemed appropriate for a Regulatory Affairs Specialist.
- 1-2 years regulatory affairs experience
- A B.Sc. (or equivalent) in a relevant area of chemical or biological sciences is preferred.
- Regulatory affairs certification (RAC), certificates, diploma or ongoing training in regulatory affairs.
- Strong technical writing, analytical and planning skills.
- Excellent oral and written communication skills.
- Familiarity with ISO 9001, ISO 13485 and medical device
At DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment.
Accommodations are available to support prospective employees during the recruitment and hiring process. Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.