Staff Regulatory Affairs Specialist

Hamilton, ON L9H 7L8 | Contract

Job ID: 58188 Industry: Other Area(s)

Staff Regulatory Affairs Specialist

Location: Hamilton, ON

Type: 1-Year Contract

Our client, a major healthcare equipment provider, has asked Bagg Technology Resources to assist them in finding a Staff Regulatory Affairs Specialist to join their esteemed organization on a 1-Year Contract in Hamilton, Ontario. This position is responsible for ensuring compliance with Health Canada regulations for the commercialization of medical devices. The Specialist will be responsible for guiding, advising, and mentoring members of the Specialist Team.

Why Join?

You will be able to work for a global company within the medical equipment industry. Their constantly growing business means more opportunities within the organization. They are also a Fortune 500 company and one of the largest medical technology companies.

Key Responsibilities:

  • Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation
  • Coach, guide, and advise RA team members
  • Responsible for overseeing all regulatory submissions, product technical files and devices licensing activities
  • Maintains updated knowledge of current regulations and identifies special requirements, that may exist based on product types, or current regulatory conditions and communicates these to appropriate personnel
  • Strategically expedite the registration of new products. support commercial activities while ensuring regulatory compliance
  • Plan, co-ordinate and chair pre-submission, registration, and post-market meetings with Health Canada, including the preparation of briefing materials, and meeting minutes to Health Canada
  • Represent Canada on international Regulatory teams to best ensure that the Canadian requirements are reflected in international and corporate projects
  • 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
  • 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
  • Advise on and coordinate the submission of the establishment license renewal as well as annual medical device license renewals
  • Communicate with all functional groups to ensure awareness of regulatory and quality requirements.
  • Oversee the special access program involving approvals, tracking, and final product release
  • Assist in SOP development and review
  • Monitor and maintain departmental metrics
  • Complete other regulatory activities as assigned by manager
  • Other duties as required

Requirements:

  • University Degree required
  • Post-graduate diploma in Regulatory Affairs or Quality Assurance
  • At least four to five years’ experience in a regulatory affairs and quality assurance environment required
  • 1 year of experience in people management and development an asset
  • Working knowledge of medical device regulations
  • Strong computer skills (Excel, Word, Power Point, Share point)
  • High standard of integrity and ability to meet deadlines
  • Highly organized and able to prioritize tasks
  • Project management and report writing; preferable
  • Strong oral and written communication skills with both internal and external contacts
  • Ability to make and support decisions with regards to regulatory and quality issues

 

To apply, please click Apply Online or submit your resume by email to: OBUresume@bagg.com

View all of our job postings at www.bagg.com

Accommodations are available upon request to support your participation during all stages   of the recruitment process.

 


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