Regulatory Affairs Specialist

Natus Medical Incorporated; Oakville; Hybrid; CAD 75,000 - 90,000; Full time

Job summary

A leading healthcare technology company is seeking a Regulatory Affairs Specialist for a 12-15 month contract in Oakville, Ontario. This hybrid role involves supporting compliance with EU MDR initiatives and collaborating on regulatory projects. Candidates should possess a relevant bachelor's degree and a strong background in medical device regulations. This position offers the opportunity to work within a collaborative team focused on quality and patient care.

Benefits

Opportunity to work on meaningful projects

Collaborative team environment

Experience in a global environment

Qualifications

• 6 months of relevant experience in medical device regulatory affairs.
• Strong knowledge of medical device regulations including ISO13485.
• Ability to monitor project progress and report on compliance milestones.

Responsibilities

• Support planning and execution of EU MDR projects.
• Interpret and apply regulatory requirements.
• Develop and maintain internal quality procedures.

Skills

Technical writing skills

Interpersonal skills

Knowledge of ISO13485

Critical thinking

Education

Bachelor’s degree in a relevant field

Job description

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Regulatory Affairs Specialist (12-Month Contract – Hybrid Role)

Location : Oakville, Ontario, Canada

Work Arrangement : Hybrid- must be able to commute to our Oakville Office

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).

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.

Seniority level

Seniority level

Not Applicable

Employment type

Employment type

Contract

Job function

Job function

Legal

Industries

Hospitals and Health Care and Medical Equipment Manufacturing

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