Regulatory Affairs Specialist
Adecco Canada
Job Description
Adecco is currently hiring a full-time Regulatory Affairs Specialist to join our client's team in a highly regulated industry. This is an exciting opportunity for a detail-oriented regulatory professional who is passionate about compliance, product quality, and supporting innovative product development. In this role, you will work closely with cross-functional teams to manage regulatory submissions, support product development initiatives, maintain compliance with global regulations, and ensure timely approvals across multiple markets.
If you have experience navigating FDA, EU, and international regulatory requirements and enjoy working in a collaborative, fast-paced environment, we'd love to hear from you. Pay Rate: $85,000 - $90,000/year based on experience)Location: Ottawa, ONShift: Monday - Friday | 8am-5pm Job type: Temporary | Full-time | 10=8-month contract Vacancy Status: This posting is for an existing vacancy . Here's why you should apply: Paid weekly accurate and on time Strong health and safety programs Medical and dental benefits once qualified Free training programs New and quicker onboarding process Responsibilities: Prepare, submit, and manage regulatory submissions through approval and renewal processes Ensure product registrations remain current and compliant with applicable regulatory requirements Support internal and external regulatory and quality audits Communicate directly with regulatory agencies to facilitate approvals and respond to inquiries Serve as a key regulatory resource on product development teams, providing guidance throughout the product lifecycle Conduct regulatory assessments related to product modifications, design changes, manufacturing changes, and process improvements Collaborate with cross-functional departments including Quality, Engineering, Manufacturing, and Product Development Build strong relationships with regional and global Regulatory Affairs partners to support timely project execution Maintain compliance with company quality systems, procedures, and regulatory requirements Support ongoing initiatives that promote patient safety, product quality, and regulatory excellence Contribute to process improvements and special projects as required Qualifications and Skills: Bachelor's degree in a Scientific, Engineering, Technical, or related disciplineMinimum 3 years of Regulatory Affairs experience within a regulated industryWorking knowledge of:FDA regulationsEuropean Union (EU) regulationsInternational regulatory requirementsHands-on experience preparing and supporting regulatory submissions, including:PMA submissions510(k) submissionsTechnical FilesDesign DossiersInternational submissionsStrong attention to detail and organizational skillsExcellent verbal and written communication abilitiesAbility to manage multiple priorities and meet project deadlinesRegulatory Affairs Certification (RAC)Experience with Class III Medical DevicesUnderstanding of product development processes and design control methodologiesExperience working within quality management systems and document control environmentsProficient with:Microsoft Office SuiteAdobe AcrobatDocument control systemsQuality management softwareStrong technical writing, editing, and document review capabilitiesExcellent research, analytical, and problem-solving skillsExperience leveraging AI tools to improve efficiency, regulatory research, document generation, data organization, and workflow optimizationMu st be legally eligible to work, and reside in Canada Are you interested in this position?
Apply now! Our dynamic team of recruiters will reach out if you qualify for this role. At Adecco our purpose is simple: to make the future work for everyone.
We live our values, Passion, Collaboration, Inclusion, Courage, and Customers at Heart, by fostering a workplace where diversity is celebrated and every voice matters. We encourage applications from individuals of all backgrounds and identities. Together, we're making the future work for everyone.
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