Regulatory Affairs - CO-OP
About The Position
Synaptive is looking for motivated people to join the team and share in the challenges and rewards of developing technologies to improve patient care and outcomes in neurosurgery. We are seeking a qualified person to support growth and maintain regulatory compliance with our product portfolio in global markets. The Regulatory Affairs Specialist will assist the Regulatory Affairs Lead in generating post-market surveillance reports and assist with the creation and compilation of regulatory submissions to the FDA, Health Canada, EU and other international regulatory bodies. As a member of the Regulatory Affairs team, you will provide regulatory support for regulatory development and RnD software, visualization technologies and electromechanical medical devices projects. This is a hands-on role that may require you to roll up your sleeves from time to time and be a supportive team member. We need individuals who will feel comfortable in a fast-paced environment. This is primarily an on-site role with the opportunity for remote work when timelines and deliverables permit. This posting is for a 12-month co-op term with the possibility of extension.
Requirements
- Registered in Post-secondary Electrical, Systems or Biomedical Engineering, Life Sciences degree or equivalent. Advanced degree highly preferred
- 1-3 years of medical device experience in a similar role
- Strong attention to detail and problem-solving skills
Nice To Haves
- Experience with complex regulatory submissions in different jurisdictions (i.e., Health Canada, CE, Asia Pacific)
- Familiarity with FDA’s medical device regulations, SOR/98-282, EU MDR, ISO standards, etc.
- Experience with Electromechanical devices such as Medical Imaging Systems, Medical Device Navigation Software, Robotics, SaMD, etc. will be an asset
- Formal education or certification in Regulatory Affairs
Responsibilities
- Assist in the preparation, compilation, and submission of regulatory applications for product approvals domestically and internationally
- Conduct post market surveillance activities on existing and new products
- Maintain and update CE Technical Files
- Review submission materials including labeling and technical documentation
- Assist with change orders for the Regulatory department
- Maintain and update global product listings, facility and establishment registrations
- Draft sections of DHF and work closely with project teams for development projects to provide regulatory support and regulatory change assessments to determine filing needs
- Review complaints for regulatory reporting, recalls, or CAPAs
- Assist in responding to requests for additional information from regulatory authorities
- Review, write and contribute toward departmental SOPs
- Participate in quality systems audits as a regulatory SME as required
- Stay abreast of regulatory procedures and changes in regulatory climate and update department
- Provide support with day to day departmental activities as required
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What This Job Offers
Career Level
Intern
