Regulatory Affairs Specialist
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.
Synaptive is seeking a qualified person 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, EU and other international regulatory bodies. You will liaise with international partners for submission compilation activities in international markets and provide regulatory support to the project team for a complex electromechanical medical imaging device. As a member of the Regulatory team, you will also support other development projects and post-market surveillance activities in compliance with the EU MDR. 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.
What You’ll Do
- Coordinate and assist in the preparation, compilation, and submission of regulatory applications for product approvals domestically and internationally
- Draft sections of DHF and work closely with project teams for development projects to provide regulatory support
- Review high risk complaints for regulatory reporting
- Conduct post market surveillance activities on existing and new products
- Update clinical evaluation reports
- Conduct change assessments for updates to regulatory cleared products to determine filing needs
- Assist in responding to requests for additional information from regulatory authorities
- Review, write and contribute toward departmental SOPs and policies
- Provide support with day-to-day departmental activities as required
- Participate in quality systems audits as a regulatory SME as required
- Other duties as assigned
What You’ll Need
- Post-secondary Electrical, Systems or Biomedical Engineering, Life Sciences degree or equivalent. Advanced degree such as a master’s highly preferred
- 3-5 years of medical device experience in a similar role
- Submission writing experience
- Strong attention to detail and problem-solving skills
It’d Be Amazing If You Had
- 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
- 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 in order to capture and document various regulatory submission materials such as technical files and 510k documentation
- Ability to distill complex concepts into clear messaging
Synaptive has a special duty to take a leadership role in protecting the health and wellbeing of its employees and the public. The COVID-19 vaccines are an important public health measure for mitigating the spread of COVID-19 in the workplace and society. As a condition of employment, the successful candidate will be asked to provide proof of vaccination or a reason protected by legislation why they cannot be vaccinated against COVID-19.
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.
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.
- Job Family Quality
- Pay Type Salary