Regulatory Affairs Specialist II – Class III Medical Devices (Ottawa)

Boston Scientific Gruppe; Ottawa; Hybrid; CAD 66,000 - 132,000; Full time

Job summary

A leading medical technology company is seeking a Regulatory Affairs professional for a 20-month contract in Ottawa, Canada. The role focuses on supporting regulatory submissions and compliance for Class III medical devices used in liver cancer treatment. Candidates should have at least 5 years of experience in the medical device industry, knowledge of FDA and EU regulations, and be skilled in technical writing and project management. The position offers a competitive salary range from $66,500 to $131,800.

Qualifications

• At least 5 years of Regulatory Affairs experience within the medical device industry.
• Strong written and verbal communication skills.
• Demonstrated ability to use AI tools to enhance efficiency.

Responsibilities

• Prepare, submit, and manage regulatory submissions.
• Support internal and external regulatory audits.
• Communicate with regulatory agency personnel.

Skills

Regulatory Affairs experience

Knowledge of FDA and EU regulations

Submission experience

Technical writing and editing

Project management skills

Education

Degree in a scientific, engineering, or technical discipline

Regulatory Affairs certification (e.g., RAC)

Tools

Microsoft Office

Adobe Acrobat

Job description

A leading medical technology company is seeking a Regulatory Affairs professional for a 20-month contract in Ottawa, Canada. The role focuses on supporting regulatory submissions and compliance for Class III medical devices used in liver cancer treatment. Candidates should have at least 5 years of experience in the medical device industry, knowledge of FDA and EU regulations, and be skilled in technical writing and project management. The position offers a competitive salary range from $66,500 to $131,800.