Job Details

Regulatory Affairs Specialist, Junior

Title
Regulatory Affairs Specialist, Junior
Length
Full Time
Employer

Synaptive Medical Inc.

Salary
not disclosed
Location
Toronto
Ontario
Date Posted
13/11/2017 - 10:00
Closing Date
01/06/2018 - 10:00
Accepting BioReady
Yes
Job Description
Summary: 

Synaptive Medical is a newly-formed company based in Toronto, Canada, focused on developing medical equipment and applications for neurosurgical procedures. Together, these devices form a full and complete solution of visualization technologies for the operating room. In the past 10 years, the core members of Synaptive Medical have founded and grown multiple successful medical start-ups into international markets. The company is growing rapidly and has a number of opportunities 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.

Job Description

Synaptive is looking to grow its regulatory team to support the expansion of its product portfolio in global markets. The Regulatory Affairs Specialist will assist the Director of Regulatory Affairs in the creation and compilation of regulatory submissions to the FDA, Health Canada, EU and other international regulatory authorities. 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 and be a supportive team member. We need individuals who will feel comfortable in a highly technical fast-paced environment. Are you up for the challenge?

Education & Qualifications: 

Required

  • Educated to a degree level within life sciences or engineering
  • Minimum 2-3 years of medical device experience in a similar role

Highly Beneficial

  • 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, ISO standards, etc.

Beneficial

  • Past experience with Medical Device Navigation Software, instruments and/or surgical tools will be an asset

Interpersonal Skills

  • 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
Duties & Responsibilities: 
  • 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 engineering, quality and product management 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 Files
  • 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
Other Information: 

To submit an application please visit our Careers page at www.synaptivemedical.com/Careers

This job description is not intended to be all-inclusive. The employee may perform other related duties as necessary to meet the ongoing needs of the organization.

Synaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities. Applicants who require reasonable accommodation should notify a member of the Human Resources or Recruitment Team by emailing jobs@synaptivemedical.com. Please include your full name, contact information and details about your request.
We would like to thank everyone who submits a resume for these positions. Due to the volume that we receive, only those candidates selected for interviews will be contacted.