Regulatory Affairs Specialist
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
24 days ago
Vacancies:
1 Vacancy
Job Summary
- Regulatory Licensing and Submissions: Lead licensing efforts for medical device products in Canada and international markets. Prepare and manage regulatory submissions to Health Canada and other authorities. Support product classification registration and licensing for new product launches.
- Regulatory Compliance and Communication: Monitor regulatory updates and ensure ongoing compliance with Health Canada ISO FDA and EU MDR standards. Maintain accurate electronic documentation and support activities related to the companys Medical Device Establishment License (MDEL).
- Problem Reporting and Recalls: Assist with mandatory problem reporting recalls and communication with Health Canada and other regulatory agencies.
- Cross-Functional Collaboration: Work closely with Quality Assurance Product Development and Supply Chain teams to ensure regulatory and quality requirements are met throughout the product lifecycle.
Requirements
- Post-secondary education in Regulatory Affairs Life Sciences or a related discipline.
- 2 years of experience in regulatory affairs within the medical device industry.
- Experience with Health Canada medical device licensing and registrations (MDEL).
- Previous involvement in recall activities and regulatory communications is an asset.
- Strong understanding of Canadian and international regulatory frameworks (Health Canada ISO 13485 FDA EU MDR).
- Excellent analytical organizational and documentation skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- High attention to detail with a commitment to accuracy and compliance.
- Exceptional verbal and written communication skills.
- Proficiency in Microsoft technology.
Benefits
- A Collaborative Culture: Work with a team dedicated to innovation and regulatory excellence.
- Compensation: A 12 month contract and a salary aligned with your expertise. There may be an opportunity for a permanent position.
- Meaningful Impact: Contribute to the success of medical devices that enhance lives globally.
Required Skills:
Work Experience & Accomplishments -2 years of experience in regulatory affairs within the medical device industry. -Experience with Health Canada medical device licensing and registrations (MDEL). -Previous involvement in recall activities and regulatory communications is an asset. Skills & Competencies -Strong understanding of Canadian and international regulatory frameworks (Health Canada ISO 13485 FDA EU MDR). -Excellent analytical organizational and documentation skills. -Ability to manage multiple priorities and meet deadlines in a fast-paced environment. -High attention to detail with a commitment to accuracy and compliance. -Exceptional verbal and written communication skills. -Proficiency in Microsoft technology.
Required Education:
-Post-secondary education in Regulatory Affairs Life Sciences or a related discipline.
Company Industry
Aviation and Aerospace Component Manufacturing / Wellness and Fitness Services / Personal Care Product Manufacturing
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
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- IT Support
