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Job ID :
60901BR
Location :
US - California - Carlsbad
:
Job Description

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.

Thermo Fisher Scientific products are shipped and sold globally. The Regulatory Specialist I is responsible for In-Vitro Diagnostic Medical Device regulatory submission and regulatory compliance activities including SKU management processes relating to new and existing product assessment and approval.

Essential Functions:

The Regulatory Change Specialist essential functions include but are not limited to;

  • Complete product regulatory assessments and approval to comply with global and regional regulatory and company requirements
  • Serve as a team contact to gather product regulatory information into appropriate systems, spreadsheets and documents
  • Responsible for ensuring that product regulatory data input and approvals for SKU requests are processed within agreed-upon service level agreements.
  • Accountable for ensuring that all SKU launches and extensions are expedited on schedule
  • Review product labelling for compliance with applicable regulations and standards
  • Review new and existing EMEA regulatory guidance documents and prepare comments on new documents as required
  • Participate in Project Teams as required
  • Provide regulatory support for the core SKU Management processes including SKU creation and discontinuation
  • Responsible for driving key initiatives to clean existing SKU data and create tools, processes and mechanisms for maintaining clean SKU data over time
  • Provide regulatory support in process improvements that drive efficient, timely SKU management processes
  • Keep abreast of new or revised regulations regarding IVD Medical Devices
  • Conduct training and/or communicate appropriate material to internal staff to aid in compliance
  • May be required to perform other related duties as required and/or assigned
  • Some travel may be required (10%)

Education:

  • A degree in Biology, Chemistry, bio-engineering or related science or equivalent work experience would be an advantage but not essential.

Experience:

  • A minimum of 1 year of relevant experience in the life science industry would be an advantage but not essential.

The Regulatory Specialist I-

  • Should be well organized with a high level of attention to detail
  • Will able to work on multiple projects with tight deadlines
  • Has a positive attitude; works well under stress; is a strong communicator
  • Has a balance of strategic planning, analytical skills and ability to execute efficiently
  • Is hands-on, action-oriented, and able to implement change effectively
  • Able to work autonomously in a matrix-managed organization
  • Have good computer skills with working knowledge of Microsoft Excel and Word

Contacts:

The Regulatory Specialist I will liaise extensively with people at all levels/departments within the organization on matters relating to the regulatory product assessment and approval process.

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.
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