Regulatory Affairs Specialist-Contract

RiseMe; Oakville; Hybrid; CAD 60,000 - 70,000; Full time

Job summary

Natus Medical in Oakville, Ontario, is seeking a Regulatory Affairs Specialist for a 9‑month contract. The hybrid role supports international regulatory submissions across LATAM, APAC and EMEA, updating procedures and liaising with global teams. English fluency required and travel up to 10%.

The ideal candidate has a Bachelor's in Regulatory Affairs or related field, 1+ year in medical device regulatory affairs, and knowledge of ISO 13485/MDR/MDD. RAC is a plus.

Qualifications

• Bachelor's degree in Regulatory Affairs, Quality, Life Sciences, Engineering or related field.
• Minimum 1 year of experience in medical device regulatory affairs.
• Strong knowledge of ISO 13485, MDD, MDR and international frameworks.
• Regulatory Affairs Certification (RAC) is a plus.
• Excellent technical writing and attention to detail.

Responsibilities

• Coordinate and prepare document packages for regulatory submissions for new and mature products.
• Interpret and apply regulatory requirements across global markets; assist with EU MDR and other standards.
• Develop and maintain internal quality procedures and product documentation.
• Collaborate with global Regulatory Affairs teams to ensure compliance.
• Prepare Technical Files and Design Dossiers for CE marking and submissions.
• Monitor MDR milestones and support audits by Notified Bodies and authorities.

Skills

Regulatory knowledge

Technical writing

Attention to detail

Communication

Project management

Education

Bachelor's degree in Regulatory Affairs, Quality, Life Sciences, Engineering

Job description

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 atNatus Neuro.

Job Function: Quality Assurance & Regulatory

Job Family: Regulatory Affairs

About the Role

We’re currently seeking a Regulatory Affairs Specialist for a 9-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.

Job Overview:

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.

Responsibilities:

This entry-level professional role is focused on learning to apply formal training and foundational professional concepts to assigned tasks. The position involves gaining familiarity with standard problem-solving methodologies and learning to recognize and elevate issues or abnormalities to more experienced staff before acting on solutions.

The role requires clear and effective communication with coworkers, as well as active listening and the ability to provide factual responses. Project assignments are typically defined by others, and work is reviewed frequently to ensure alignment with expectations.

While independent responsibility is minimal, the individual is expected to contribute as a member of a team and begin developing basic work planning skills. Timely communication with leadership regarding potential delays or issues is essential. This role is designed to provide foundational experience and support professional growth in a structured environment.

Contribute to the team's success by embracing our guiding principles and behaviors and actively participating in a culture that puts our Patient first. You will demonstrate exceptional teamwork, agility, accountability, and respect, cultivating an environment where collaboration and continuous improvement thrive.

Location: Oakville, Ontario, Canada
Work Arrangement: Hybrid – must be able to commute to our Oakville Office
Contract Length: 9 months

Key Responsibilities

• 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 maintaininternal quality procedures and product‑specific documentation.
• Collaborate with global Regulatory Affairs teams to ensure consistency and compliance.
• Prepare and maintainTechnical 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.

What You Bring

• Bachelor’s degree in Regulatory Affairs, Quality, Life Sciences, Engineering, or a related field.
• Minimum of 1 yearof 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.

Other Requirements

• Travel up to 10% (as needed).
• English language fluencyrequired.

Experience Required:

This level is intended for individuals beginning their professional careers or transitioning into a new field. Candidates are expected to have recently completed formal education or training relevant to the role. No or limited prior professional experience may be required, though internships or academic projects may be beneficial. The role focuses on learning core concepts, following structured guidance, and developing the skills needed to perform assigned tasks reliably with support and oversight.

Canada Pay Transparency Clause

This posting is for an existing vacancy. The expected annual base salary for this position is $60-70K 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.

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. This posting is for an existing vacancy.

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