Compliance Specialist II - Regulatory Affairs

Thermo Fisher Scientific Inc.; Waltham (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in the healthcare industry is seeking a Compliance Specialist II - Regulatory Affairs for a temporary role lasting 16-18 months. The position involves ensuring product compliance with regulations, performing regulatory reviews, and training stakeholders. Ideal candidates should have a Bachelor's degree and significant experience in regulatory affairs within the medical device or pharmaceutical fields.

Benefits

Benefits included in the opportunity

Qualifications

• 3+ years in regulatory affairs, ideally in medical devices or pharmaceuticals.
• Strong understanding of federal, state, and international regulations.
• Ability to perform regulatory reviews and maintain compliance.

Responsibilities

• Review items/products for onboarding and regulatory compliance.
• Prepare regulatory compliance reports for submissions.
• Train team members on new regulations and audit processes.

Skills

Attention to detail

Interpersonal skills

Problem-solving

Regulatory compliance

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.