Regulatory Affairs Specialist, Junior

7 days ago

Toronto, Ontario, Canada Synaptive Medical Inc. 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 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 teams for software and electromechanical medical devices.

As a member of the Regulatory team, you will also support other regulatory development projects and post-market surveillance activities.

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

  • 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
  • Conduct change assessments
  • Assist in responding to requests for additional information from regulatory authorities
  • Review, write and contribute toward departmental SOPs and policies
  • Provide support with daytoday departmental activities as required
  • Participate in quality systems audits as a regulatory SME as required
  • Other duties as assigned
What You'll Need

  • Postsecondary Electrical, Systems or Biomedical Engineering, Life Sciences degree or equivalent. Advanced degree such as a master's highly preferred
  • 13 years of medical device experience in a similar role
  • Strong attention to detail and problemsolving 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/98282, 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
About You

  • Friendly and positive attitude
  • Excellent written communication skills
  • Selfmotivated and selfmanaging
  • Excellent attention to detail
  • Ability to work in a highlytechnical, fastpaced 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
COVID-19 Considerations

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

How to Apply

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