Regulatory Affairs Specialist

Regulatory Affairs Specialist: 12-month Contract Job Description

Posted Monday, January 19, 2026 at 8:00 AM

FOR MORE THAN 80 YEARS
, Natus has been working in collaboration with clinicians to deliver industry‑leading neuro solutions that help providers more easily make sense of the body’s signals.

Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.

Location:

Oakville, Ontario, Canada
Work Arrangement:
Hybrid – must be able to commute to our Oakville Office
Contract Length: 12 months

We’re currently seeking a Regulatory Affairs Specialist for a 12‑month contract position to support and manage international regulatory submissions and registration processes 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.

• Manage international regulatory submissions and registration processes, including regions such as LATAM (e.g., Brazil ANVISA), APAC (e.g., Japan PMDA, China NMPA), and EMEA markets.
• 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.
• Support audits from Notified Bodies, Competent Authorities, and other regulatory agencies.

• Bachelor’s degree in Regulatory Affairs, Quality, Life Sciences, Engineering, or a related field.
• Minimum of 1 year of relevant experience in medical device regulatory affairs.
• Strong knowledge of medical device regulations: ISO 13485, MDD, MDR, and other international frameworks.
• Technical writing skills and attention to detail.
• Ability to work methodically and drive continuous improvement.
• Regulatory Affairs Certification (RAC) is a plus.

Travel up to 10% (as needed).

Canada Pay Transparency Clause:
This posting is for an existing vacancy. The expected annual base salary for this position is $55-75K CAD. This role may also be eligible for a company bonus or commission plan, as applicable to the position. Canadian work experience is not required. Automated or artificial intelligence–assisted tools may be used in the screening or assessment of applicants. Candidates who participate in an interview will be advised whether a hiring decision has been made within 45 days of the final interview, in accordance with applicable law.

Be the People part of the Neuro Solution. Apply Today.

Accessibility:
Natus is committed to creating an inclusive environment that accommodates all individuals, including those with disabilities. We support the goals of the Accessibility for Ontarians with Disabilities Acts (AODA) and have established policies, procedures and practices which adhere to the accessibility standards set out in the AODA. Should you require any accommodation throughout the recruitment process please do not hesitate to contact our Human Resources Department.

EEO Statement:
Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.