Regulatory Affairs Specialist

Natus Medical Incorporated; Oakville; Hybrid; CAD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist for a 12-15 month hybrid contract. This role focuses on supporting EU MDR initiatives and ensuring compliance across global markets. You'll work collaboratively on meaningful projects, interpreting regulatory requirements, and maintaining internal quality procedures. Join a dynamic team committed to innovative healthcare technologies, where your contributions will significantly impact patient care and quality. If you have a passion for regulatory affairs and a desire to make a difference, this opportunity is perfect for you.

Qualifications

• Minimum of 6 months of relevant experience in medical device regulatory affairs.
• Strong knowledge of medical device regulations and frameworks.

Responsibilities

• Support planning and execution of EU MDR projects.
• Prepare and maintain Technical Files for regulatory submissions.
• Provide MDR training to cross-functional teams.

Skills

Regulatory Affairs

Technical Writing

ISO13485

MDD

MDR

FDA QSR

Communication Skills

Education

Bachelor's degree in Regulatory Affairs

Bachelor's degree in Quality

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Job description

Regulatory Affairs Specialist (12-Month Contract – Hybrid)

Location: Oakville, Ontario, Canada

Work Arrangement: Hybrid

Contract Length: 12 -15 month

About The Role

We’re currently seeking a Regulatory Affairs Specialist for a 12-15month contract position to support our EU MDR (Medical Device Regulation) initiatives and ensure ongoing compliance across global markets. This role is hybrid, based in Oakville, Ontario, and offers the opportunity to work on meaningful projects in a collaborative and dynamic environment.

Key Responsibilities

• Support planning and execution of EU MDR projects in collaboration with the site lead.
• Interpret and apply regulatory requirements, with a focus on EU MDR 2017/745 and global standards.
• Develop, update, and maintain internal quality procedures and product-specific documentation.
• Collaborate with global Regulatory Affairs teams to ensure consistency and compliance.
• Prepare and maintain Technical Files and Design Dossiers for CE Marking and regulatory submissions.
• Monitor project progress and report on MDR compliance milestones.
• Provide MDR training/briefing sessions to cross-functional teams.
• Contribute to international submissions and registration processes.
• Support audits from FDA, Notified Bodies, Competent Authorities, and other regulatory agencies.
  
  

What You Bring

• Bachelor’s degree in Regulatory Affairs, Quality, Life Sciences, Engineering, or a related field.
• Minimum of 6 months of relevant experience in medical device regulatory affairs.
• Strong knowledge of medical device regulations: ISO13485, MDD, MDR, FDA QSR (21 CFR Part 820), Health Canada, and other international frameworks.
• Technical writing skills and attention to detail.
• Ability to work methodically and drive continuous improvement.
• Excellent communication and interpersonal skills.
• Regulatory Affairs Certification (RAC) is a plus.
  
  

Other Requirements

• Travel up to 10% (as needed).
• Must be eligible to work in Canada.
• English language fluency required.
  
  

Why Join Natus?

• Make an impact by supporting innovative healthcare technologies.
• Join a collaborative team committed to quality and patient care.
• Gain valuable experience in a global, regulated environment.
  
  

Accessibility & Equal Opportunity

Natus is committed to providing an inclusive and accessible workplace. If you require accommodation during the recruitment process, please contact our Human Resources team. We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, gender identity, sexual orientation, disability, or any other protected status.