Compliance Specialist II - Regulatory Affairs
Compliance Specialist II - Regulatory Affairs
Posted on :
13-06-2025
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1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
This site-based role is a temporary assignment for 16-18 months through July 2026. Benefits are included in this opportunity. Talent must live near the Ottawa site to be on-site 5 days/week. As a Compliance Specialist II - Regulatory Affairs you will be responsible for the following tasks:
- Take part in all aspects of the Regulatory job function which involves reviewing items/products for onboarding addressing specific product inquiries and tracking team performance.
- Apply internal screening processes to perform daily comprehensive regulatory reviews of new products.
- Ensure product compliance with applicable federal state and international regulations including TDG CSA and Canadian medical device regulations NHP regulations etc.
- Assist with customer order approvals including restricted components as needed.
- Maintain required regulatory permits and licenses such as Precursor A & B Restricted Components Controlled Goods (CGP) Medical Device Licenses Medical Device Establishment Licence NHP Site Licence etc.
- Perform regulatory surveillance for new or changing regulations with federal agencies.
- Assist the Distribution Center Customs Compliance and Supply Chain Departments as required.
- Train collaborators customers partners and team members on new regulations.
- Assist with compliance audits both internal and external.
- Prepare various regulatory compliance reports for submission to government agencies.
- Participate in Regulatory Group projects PPI-Teams and system-application improvement initiatives.
- Develop Work Instructions for core Regulatory functions and update existing Standard Operating Procedures (SOPs) as needed.
- Work with internal and external departments to facilitate problem resolution.
Qualifications and Requirements:
The ideal candidate for the Compliance Specialist II - Regulatory Affairs role will possess the following qualifications:
- Bachelors degree in a related field or equivalent work experience.
- 3 proven experience in regulatory affairs ideally within the medical device or pharmaceutical industry.
- Strong understanding of federal state and international regulations.
- Outstanding attention to detail and ability to perform comprehensive regulatory reviews.
- Demonstrate ability to maintain regulatory permits and licenses.
- Strong interpersonal skills both written and verbal with the ability to provide training to collaborators.
- Ability to balance multiple projects and priorities simultaneously.
- Strong problem-solving skills and the ability to work collaboratively with various departments.
- Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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