Strategic Regulatory Affairs Specialist, MedTech (Canada)

NBSTSA; Markham; On-site; CAD 61,000 - 99,000; Full time

Job summary

Johnson & Johnson is seeking a Regulatory Affairs Specialist in Markham, Ontario, Canada. You will develop Canadian regulatory strategies for complex Class III and IV medical devices, manage lifecycle regulatory activities, and provide guidance to internal teams.

You will establish Health Canada relationships, coordinate submissions, and ensure compliance with regulatory requirements while supporting audits and continuous process improvements.

Qualifications

• University/Bachelor's or equivalent degree in a Life Science, Engineering, or Physical Science is required.
• Completion of a post-graduate program in Quality/Regulatory Affairs is preferred.
• 3–5 years of experience in Medical Device and/or Pharmaceutical/Biologics Regulatory Affairs is preferred.
• Sound knowledge of Food and Drugs Act and Regulations and relevant policies and guidelines is required.
• Experience in managing regulatory submission activities is required.

Responsibilities

• Develop and execute Canadian Regulatory strategies for complex Class III and Class IV medical devices.
• Manage all Regulatory aspects of the product lifecycle from pre-market to post-marketing including review of promotional material.
• Provide Regulatory consultation for business partners and internal stakeholders.
• Establish and maintain strong Health Canada relationships, driving submission strategies and regulatory pathways.
• Maintain the Quality Management System (QMS) at DePuy Synthes in line with Health Canada regulations and corporate requirements.
• Support internal and external audits, including Health Canada and MDSAP inspections.
• Monitor regulatory issues and communicate changes; coordinate comments on proposed regulations.

Skills

Analytical thinking

Business writing

Collaboration

Communication

Regulatory awareness

Problem solving

Product licensing

Public policies

Regulatory affairs management

Regulatory compliance

Regulatory environment

Regulatory reporting

Risk assessments

Strategic thinking

Education

Bachelor's degree in Life Science, Engineering, or Physical Science

Post-graduate program in Quality/Regulatory Affairs

Job description

Johnson & Johnson is seeking a Regulatory Affairs Specialist in Markham, Ontario, Canada. You will develop Canadian regulatory strategies for complex Class III and IV medical devices, manage lifecycle regulatory activities, and provide guidance to internal teams.

You will establish Health Canada relationships, coordinate submissions, and ensure compliance with regulatory requirements while supporting audits and continuous process improvements.