Ville : Ottawa

Catégorie : Yearly Temporary/Contract

Industrie : Recruitment/Staffing

Employeur : The Adecco Group

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, ON

• Shift: 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 discipline

• Minimum 3 years of Regulatory Affairs experience within a regulated industry

• Working knowledge of:

  • FDA regulations

  • European Union (EU) regulations

  • International regulatory requirements

• Hands-on experience preparing and supporting regulatory submissions, including:

  • PMA submissions

  • 510(k) submissions

  • Technical Files

  • Design Dossiers

  • International submissions

• Strong attention to detail and organizational skills

• Excellent verbal and written communication abilities

• Ability to manage multiple priorities and meet project deadlines

• Regulatory Affairs Certification (RAC)

• Experience with Class III Medical Devices

• Understanding of product development processes and design control methodologies

• Experience working within quality management systems and document control environments

• Proficient with:

  • Microsoft Office Suite

  • Adobe Acrobat

  • Document control systems

  • Quality management software

• Strong technical writing, editing, and document review capabilities

• Excellent research, analytical, and problem-solving skills

• Experience leveraging AI tools to improve efficiency, regulatory research, document generation, data organization, and workflow optimization

• Must 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.

Please reach out to learn how the Aspire Academy can upskill you into your next role.

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