Senior QA & Regulatory Affairs Leader - Hybrid (Toronto)

MIMOSA Diagnostics Inc.; Toronto; Hybrid; Full time

Benefits offered by this job

Comprehensive benefits program (medical, dental, vision)

Discretionary time off

MIMOSA Days

Job summary

A healthcare technology company in Toronto is seeking a Senior Quality Assurance/Regulatory Affairs Specialist to ensure compliance with regulatory standards and quality assurance processes. This full-time hybrid position requires strong experience in the medical device industry, with responsibilities ranging from developing quality strategies to conducting audits. The ideal candidate will have a Bachelor’s degree in a relevant field and a minimum of 3 years of experience. The company values diversity and offers a comprehensive benefits program.

Qualifications

• Minimum of 3 years experience in quality assurance and regulatory affairs.
• In-depth knowledge of regulatory requirements like FDA, ISO.
• Experience with regulatory submissions for medical devices.

Responsibilities

• Develop quality assurance strategies and compliance programs.
• Conduct internal audits and inspections for quality adherence.
• Prepare regulatory documents and collaborate cross-functionally.

Skills

Quality assurance management

Regulatory affairs knowledge

Analytical skills

Communication skills

Interpersonal skills

Education

Bachelor’s degree in Science or related field

Tools

Electronic quality management system

Job description

A healthcare technology company in Toronto is seeking a Senior Quality Assurance/Regulatory Affairs Specialist to ensure compliance with regulatory standards and quality assurance processes. This full-time hybrid position requires strong experience in the medical device industry, with responsibilities ranging from developing quality strategies to conducting audits. The ideal candidate will have a Bachelor’s degree in a relevant field and a minimum of 3 years of experience. The company values diversity and offers a comprehensive benefits program.