Compliance Specialist I - Regulatory Affairs

Work Schedule

Environmental Conditions

Job Description

Please note this role is an 18-month Fixed Term Contract Starting in February 2025- August 2026

What Makes This Opportunity Unique

At Thermo Fisher Scientific Inc., we pride ourselves on our unwavering focus on innovation and excellence. Joining our team as a Compliance Specialist I - Regulatory Affairs means becoming part of a world-class organization with an ambitious vision for the future. Here, you will have the opportunity to work on exceptionally meaningful projects that have a global impact. You will collaborate with a diverse team of experts committed to advancing regulatory compliance and ensuring the flawless delivery of our products to market.

Key Responsibilities

As a Compliance Specialist I- 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 role will possess the following qualifications:

• Bachelor's degree in a related field or equivalent work experience.
• 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.
• Demonstrated ability to maintain regulatory permits and licenses.
• Strong communication 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.

Why Join Us?

At Thermo Fisher Scientific Inc., we offer a dynamic and inclusive work environment where your contributions are valued and recognized. We provide opportunities for professional growth and development, and we are committed to helping you succeed. Join us and be part of a team that is determined to make a positive impact on the world.