Regulatory Affairs Specialist

2 weeks ago


Reston, Virginia, United States GForce Life Sciences Full time

Job Title: Regulatory Affairs Specialist

Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GForce Life Sciences. The ideal candidate will have a strong background in regulatory compliance and quality systems.

Key Responsibilities:

  • Implement and maintain quality systems to ensure compliance with regulatory requirements.
  • Support day-to-day manufacturing and operations activities related to change control.
  • Provide consultation and advice to regulatory specialists regarding change control and product development.
  • Offer regulatory direction and interpretation on team activities.
  • Apply regulatory knowledge to support product-related activities.
  • Prepare regulatory submissions and registration documents for international affiliates and government agencies worldwide.
  • Manage regulatory activities related to documentation, labeling, and field support.
  • Apply regulatory and technical knowledge to complex work assignments.
  • Ensure compliance with the appropriate quality system for supported medical devices.
  • Maintain and demonstrate knowledge of site and division-level policies and procedures.

Requirements:

  • Collaborate effectively with cross-functional teams.
  • Stay informed about changes in regulations and standards affecting medical devices.
  • Participate in audits and inspections as needed.
  • Contribute to continuous improvement initiatives within the regulatory affairs function.
  • Ability to prioritize tasks and manage multiple projects simultaneously.

Education and Experience: Bachelor's degree preferred in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, or related field. 2-5 years of regulatory experience and/or 2 years of relevant industrial experience, typically within a quality, product development/support, or scientific affairs function.

Work Environment: This is a full-time position that requires on-site work in Alameda, CA, 5 days per week. Must be able to work on a W2. We offer a competitive salary and benefits package.



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