The Regulatory Affairs Specialist will lead the regulatory activities to obtain and maintain product registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures. You will lead and support product registration and serve as the subject matter expert for Regulatory Affairs and provide guidance to local and global business partners. The Specialist will develop and implement regulatory strategies to meet project deliverables.
Our client is a leading North American Manufacturer of Medical Devices marketed to Hospitals. They are looking for a Regulatory Affairs Specialist based in GTA. If you’re a Regulatory Affairs Specialist with 2 or more years experience in the Medical Device or Pharmaceutical Market. This is a great opportunity to join a true Market Leader!
Your essential responsibilities will include the following:
·Author submissions and other regulatory documents to obtain approval to bring new or modified products to market. (Class II, III and IV applications)
·Assess changes made to the device post launch to determine if the changes which are being made impact device license
·Utilize time management skills to effectively write, coordinate, and execute regulatory items
·Work with Marketing to develop annual product submission plans
·Advise on and coordinate the submission of the establishment license renewal as well as annual medical device license renewals
·Stay abreast of regulatory procedures, evolving regulations and guidelines and changes in the regulatory climate
·Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
·Investigate regulatory history of similar products to assess approval implications
·Attends to internal and external regulatory and licensing inquiries
· Communicate with all functional groups to ensure awareness of regulatory and quality requirements.
·Ensures scheduled submission dates are met and reports to management and marketing staff on regulatory product status and submission progress
·Coordinates special access program involving approvals, tracking, and final product release.
·Respond to RA information requests
·Assist in SOP development and review
·University Degree required .
·Post Graduate Regulatory Affairs Certification (RAC).
·A minimum of 2 years hands-on experience with Regulatory Affairs and Quality Assurance.
·Excellent communication, interpersonal and time management skills.