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Job ID :
36633BR
Location :
US - California - Fremont|US - Michigan - Kalamazoo|US - New Hampshire - Portsmouth
:
Job Description

Company Information

About Us

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Position Summary:

  • Write, prepare, and manage regulatory submissions and filings required for U.S. FDA and other international authorities (i.e. 510(k), CE Marking, etc.)
  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
  • Prepare documentation to support international registration dossiers and maintain product registration files and electronic databases.
  • Act as core member on project teams to provide regulatory guidance and strategic regulatory planning in support of new product development and existing product support.
  • Participate in inspections/audits by the notified body or other international regulatory agencies to include USDA by producing requested documents or answering any inquiries for information.
  • Assist in the development of regulatory best practices, processes and procedures.
  • Perform other duties as required.

Minimum Requirements/Qualifications:

  • Minimum of a Bachelor’s degree is required; majors in Science or Engineering are preferred.
  • Minimum of four (4) years of experience working in a regulated environment/industry are required.
  • RAPS certification preferred
  • 510k Submission Experience preferred
  • ISO 13485 Lead Auditor Certification preferred
  • Experience in a manufacturing environment preferred
  • Excellent communication and attention to detail
  • Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude
  • Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
  • Must demonstrate leadership skills
  • Proficient in MS applications (Excel, Word, Outlook)

Non-Negotiable Hiring Criteria:

  • Bachelor of Science degree in Quality engineering or related field
  • Minimum of four (4) years of experience working in a regulated environment/industry are required.
  • Regulatory Affairs (Class I Medical Devices) experience or equivalent required (5+ years)
This position has not been approved for relocation assistance.

*IND-SDG

*LI-KP1

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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.
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