Global Regulatory Affairs Associate — 9-Month 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

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.