Thermo Fisher Scientific Regulatory Compliance Specialist in Oakwood Village, Ohio
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
This position is located in Tewksbury, MA
How will you make an impact?
You will be responsible for the deployment of policies and programs to ensure compliant business operations and minimize risk. The ideal candidate will have global compliance experience in areas such as ROHS, and REACH, Prop 65, China and other regional specific requirements applicable to the Field and Safety Instruments portfolio
What will you do?
Maintain critical documentation as it pertains to global sales, distribution, and product safety. Particular focus is on products containing lithium ion and lithium metal batteries as well as radioactive by-product material, X-Ray devices and laser devices.
Keep current with changing global regulations and standards and communicate proposed & impending changes to ensure business continuity and compliance is maintained.
Represent the business in global standards organizations.
Work with regional teams to ensure company compliance with local regulatory guidelines and communicate with product management and product development teams to ensure alignment
Create programs and systems to manage compliance requirements. Implement performance metrics to identify areas of improvement or areas that could lead to non-compliance.
Keeping updated with the latest changes in regulatory requirements and trends
Participate in Risk Assessment activities such as Hazard Analysis and FMEA’s.
Assist in identification & selection of new and alternate components.
Learn and evaluate cutting edge devices and standards, and apply applicable standards for both commercial and development products
Respond to customer inquiries
Collaborate in a team environment and assist in development and improvement of test methodologies, reporting, and coordination of various tasks.
How will you get here?
Minimum bachelor’s degree in an engineering or a scientific discipline is required
5+ years working in a closely related compliance capacity
Must be U.S. Citizen or Green Card Holder
Must have knowledge of local certification processes and must be able to interact with local certification authorities
Working knowledge of regulatory requirements and industry standards preferred.
Must be able to write technical documents clearly and concisely.
Strong problem solving skills
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.