What are the responsibilities and job description for the Regulatory Affairs Specialist position at NATUS?
Regulatory Affairs Specialist (12-Month Contract – Hybrid)
Location: Oakville, Ontario, Canada
Work Arrangement: Hybrid (Remote & On-Site)
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.
#LI-DNP
