Regulatory Affairs Strategist, Medical Devices (Canada)

Biopharma Careers; Markham; Vor Ort; CAD 61.000 - 99.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Markham, Ontario, is seeking a Regulatory Affairs Specialist to lead Canadian regulatory strategies for complex medical devices. You will manage lifecycle regulatory activities from pre-market to post-market and advise internal partners.

You will maintain Health Canada compliance, support audits, and build strong relationships with Health Canada and stakeholders, while pursuing continuous improvement of the QMS and regulatory submissions.

Qualifikationen

• Bachelor’s or equivalent degree in Life Science, Engineering, or Physical Science.
• Post-graduate program in Quality/Regulatory Affairs is preferred.
• 3–5 years of Medical Device and/or Pharmaceutical/Biologics Regulatory Affairs experience.
• Knowledge of Food and Drugs Act and Regulations and relevant policies.
• Experience managing regulatory submission activities.
• Excellent verbal and written communication.
• Ability to develop and maintain strong working relationships with business partners and key stakeholders.
• Demonstrated leadership across functions.
• Experience with ISO 13485 or Quality Systems is an asset.
• Experience executing regulatory submission strategies aligned with business objectives.

Aufgaben

• Develop and execute Canadian regulatory strategies for Class III and Class IV devices.
• Manage regulatory aspects of the product lifecycle from pre-market to post-marketing.
• Provide regulatory consultation for business partners and internal stakeholders.
• Establish and maintain relationships with Health Canada and business partners.
• Maintain and continuously improve the Quality Management System (QMS) per Health Canada regulations.
• Participate in internal and external audits and inspections.
• Stay aware of regulatory issues and changes and communicate them to the business.
• Coordinate comments on proposed regulations and policies.

Kenntnisse

Analytical reasoning

Business writing

Collaboration

Communication

Problem solving

Regulatory affairs

Regulatory compliance

Regulatory environment

Strategic thinking

Risk assessments

Public policies

Product licensing

Legal support

Ausbildung

Bachelor’s degree in Life Science

Post-graduate Regulatory Affairs education

Jobbeschreibung

Johnson & Johnson in Markham, Ontario, is seeking a Regulatory Affairs Specialist to lead Canadian regulatory strategies for complex medical devices. You will manage lifecycle regulatory activities from pre-market to post-market and advise internal partners.

You will maintain Health Canada compliance, support audits, and build strong relationships with Health Canada and stakeholders, while pursuing continuous improvement of the QMS and regulatory submissions.