Regulatory Affairs Specialist-Contract

Clear Destination Inc.; Oakville; Hybrid; CAD 60,000 - 90,000; Full time

Job summary

Clear Destination Inc. in Oakville, Ontario, is seeking a Regulatory Affairs Specialist on a 9-month contract to manage international regulatory submissions and registration processes and ensure ongoing compliance across global markets.

This hybrid role requires coordinating with cross-functional teams and maintaining thorough documentation. You will work with regions such as LATAM, APAC, and EMEA, apply EU MDR 2017/745, and support audits.

Qualifications

• 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.

Responsibilities

• Coordinate and prepare documentation for regulatory submissions across global markets.
• Develop, update, and maintain technical files and design dossiers for CE marking and registrations.
• Support audits and ensure ongoing compliance with EU MDR and other frameworks.

Skills

Regulatory writing

Regulatory submissions

Cross-functional collaboration

Attention to detail

English language proficiency

Education

Bachelor’s degree in Regulatory Affairs or Life Sciences

Tools

Regulatory databases

Job description

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 escalating 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.