Regulatory Affairs Specialist
45 Innovation Drive Hamilton, ON L9H 7L8 | Direct Hire
Regulatory Affairs Specialist
Location: Hamilton, ON
Our client, a major healthcare equipment provider, has asked Bagg Technology Resources to assist them in finding a Regulatory Affairs Specialist to join their esteemed organization in Hamilton, Ontario. This position is responsible for ensuring compliance with Health Canada regulations for the commercialization of medical devices. This individual must serve as a contributing member of the Regulatory Affairs team while championing the Client's Mission and Values.
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.
- Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation
- Responsible to live and exemplify the Client's Values: Integrity, Accountability, People, and Performance
- 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
- Monitor and maintain departmental metrics
- Completes other regulatory activities as assigned by manager
- 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
- University Degree required
- Post-graduate diploma in Regulatory Affairs or Quality Assurance
- Minimum of two years’ experience in a regulatory affairs and quality assurance environment
To apply, please click Apply Online or submit your resume by email to: OBUresume@bagg.com
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Accommodations are available upon request to support your participation during all stages of the recruitment process.