Regulatory Affairs Specialist, Senior

Canada/United States     ·     Full time

About Us

Synaptive Medical is a Canadian medical device company, based in downtown Toronto, focused on supporting healthcare professionals and systems in patient diagnosis and treatment. Synaptive’s suite of products include MRI, surgical planning, navigation, and robotic visualization – all of which can be seamlessly combined or used independently in the operating room. The company has a number of opportunities for innovative people to join the team and share in the development of technologies to solve surgical and imaging challenges in patient care. 

The Opportunity          

Synaptive is looking to grow its regulatory team to support growth of its product portfolio in global markets. The Regulatory Affairs Specialist will assist the Regulatory Affairs Manager in the creation and compilation of regulatory submissions to the FDA, Health Canada, and other international regulatory bodies. You will also liaise with international affiliates for submission compilation activities, maintain current registrations and submit documentation on schedule as directed. This is a hands-on role that may require you to roll up your sleeves from time to time to support the team. We need individuals who will feel comfortable in a fast-paced environment.

What You’ll Do          

• Coordinate and assist in the preparation, compilation, and submission of regulatory applications for product approvals domestically and internationally
• Compile all materials in an orderly fashion to facilitate timely submission of materials to regulatory authorities
• Review submission materials including labeling and technical documentation, etc. for errors prior to submission
• Assist in responding to requests for additional information from regulatory authorities
• Communicate with Systems Engineers, Design Engineers and Quality Engineers to understand product concepts and capture the learned material in regulatory submissions
• Maintain and update global product listings, facility, and establishment registrations
• Maintain and update CE Technical Documentation
• Participate in quality systems audits as a regulatory SME as required
• Review, write and contribute toward departmental SOPs and policies
• Assist with review of change controls, promotional materials, and labeling
• Participate in product development team meetings 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

What You’ll Need

• Electrical, Systems or Biomedical Engineering, Life Sciences degree or equivalent
• Minimum 5-7 years of medical device experience in a similar role

It’d Be Amazing If You Had

• Experience with regulatory submissions in other jurisdictions (i.e., Health Canada, CE, Asia Pacific)
• Familiarity with FDA’s medical device regulations, SOR/98-282, EU MDD and MDR, ISO standards, etc.
• Experience with Medical Device Navigation Software, instruments and/or surgical tools will be an asset

About You

• Friendly and positive attitude
• Excellent written communication skills
• Self-motivated and self-managing
• Excellent attention to detail
• Ability to work in a highly technical, fast-paced environment
• Ability to take ownership of a problem and see it through resolution
• Ability to communicate clearly and effectively with technical team members to capture and document various regulatory submission materials such as technical files and 510k documentation
• Ability to distill complex concepts into clear messaging

Diversity & Inclusivity

Synaptive is based out of one of the most diverse countries in the world. This includes differences related to race, ethnicity, national origin, gender, gender expression and presentation, sexual orientation, religion, age, ability and socioeconomic status. To us, diversity is one our strongest assets to our organization. We commit ourselves to promoting the recognition and appreciation of our diverse and rich culture. We believe that it is critical to our success to promote freedom of thought and opinion in a respectful environment. The decisions we make are rooted by respectfully considering each other’s thoughts and opinions and by working towards a greater common goal, saving lives.

Accommodation

Synaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities. We welcome and encourage applications from people with disabilities. If as a qualified job applicant, you request accommodation, Synaptive will consult with you to provide reasonable accommodations according to your specific needs. If you wish to make a request, you will be provided an opportunity if your application is selected to proceed in our hiring process.

How to Apply

Unless otherwise stated, applications will only be considered from candidates eligible to work in Canada, or the country in which they’re applying to, without sponsorship.

If you are interested in this position and can demonstrate that you meet or exceed the requirements defined in the job description, please include #GOBRAIN in the top right corner of your resume and then complete your online application by clicking “Apply Now” and following the prompts.

The successful candidate to this role will be asked to complete background checks, which may include criminal, credit, employment and/or educational checks. All offers of employment are conditional on the receipt of satisfactory results of any applicable background check.

We would like to thank everyone who submits an application. Due to the volume that we receive, only those candidates selected for interviews will be contacted.

Please click here to apply.