Regulatory Affairs Specialist

4 days ago


Lake Forest, Illinois, United States Collabera Full time

We are seeking a Regulatory Affairs Specialist to join our team in the Infectious Disease business unit.

The successful candidate will be responsible for preparing documentation for EU Technical Files and international product registrations.

This is an excellent opportunity for a skilled Regulatory Affairs professional to take their career to the next level with a leading global company.

Key Responsibilities:

  • Preparation of technical documentation for regulatory submissions
  • Research and analysis of regulatory requirements
  • Development of regulatory strategies for products
  • Collaboration with cross-functional teams to ensure compliance
  • Management of regulatory databases and records

Requirements:

  • Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or related field
  • 4+ years' experience in Regulatory Affairs
  • Strong knowledge of IVDR and EU regulatory requirements

Salary: $80,000 - $110,000 per year, depending on experience. Benefits include health insurance, retirement plan, and paid time off. Located in a major US city, this role offers a great work-life balance and opportunities for growth and development.



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