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Regulatory Affairs Specialist

2 months ago

Seattle, Washington, United States BioTalent Full time
About the Role

We are seeking a detail-oriented Regulatory Affairs Associate II to join our team at BioTalent. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with FDA and international regulations for our in-vitro diagnostic (IVD) products.

Key Responsibilities:

  • Represent and lead Regulatory Affairs in product life cycle teams.
  • Draft and review protocols for analytical studies supporting regulatory submissions.
  • Assist with the preparation and submission of regulatory documents such as EUAs and 510(k)s.
  • Support international product registrations, maintain technical files, and prepare product dossiers.
  • Lead Risk Management initiatives and ensure regulatory compliance in labeling and marketing materials.
  • Set regulatory strategies for new product development.
  • Stay informed about the latest regulatory trends and requirements.
  • Communicate with regulatory authorities, including the FDA, regarding product submissions.

Requirements:

  • Bachelor's or Master's degree in life sciences or bioengineering, with at least 5 years of experience in an FDA-regulated IVD environment, or a Ph.D. with 2 years of relevant experience.
  • Preferred certification in regulatory affairs.
  • In-depth knowledge of US and international IVD regulations.
  • Strong communication skills, both written and verbal.
  • High attention to detail and excellent organizational skills.
  • Proficiency with technical systems (e.g., MS Office, statistical tools, online research).
  • Experience with regulatory submissions (EUA, 510(k), De Novo, PMA) for lateral flow and PCR assays.
  • Ability to identify and manage compliance risks.

Work Environment:

This position requires on-site work, primarily in an office setting with long periods at a computer. Some tasks involve working in a BSL-2 laboratory and controlled environments.

Compensation and Benefits:

  • Annual Salary: $90,000 - $125,000
  • Comprehensive benefits including medical, dental, vision, life insurance, and long-term disability coverage.
  • Enrollment in retirement savings plans (401k/Roth IRA) and Flexible Savings Accounts (FSA).
  • Paid vacation: 2 weeks annually, plus 11 paid holidays, including a winter break at the end of the year.