Compliance Specialist II - Regulatory Affairs

Thermo Fisher Scientific; Ottawa; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading company in the medical device sector is seeking a Compliance Specialist II for a temporary assignment in Ottawa. This role involves comprehensive regulatory reviews, ensuring compliance with local and international regulations, and requires strong interpersonal skills to train collaborators. The position offers competitive benefits and the opportunity to work closely with various departments to facilitate product compliance and address inquiries.

Benefits

Benefits included

Office environment

Qualifications

• 3+ years proven experience in regulatory affairs, ideally in the medical device or pharmaceutical industry.
• Strong understanding of federal, state, and international regulations.
• Proficiency in preparing regulatory compliance reports.

Responsibilities

• Responsible for regulatory reviews, compliance audits, and maintaining required regulatory permits.
• Assist with customer order approvals and train team members on new regulations.
• Participate in Regulatory Group projects and system-application improvements.

Skills

Attention to detail

Regulatory compliance

Interpersonal skills

Problem-solving

Education

Bachelor's degree in a related field

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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:

• Bachelor's 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.