Regulatory Affairs Specialist

2 weeks ago

Irvine, United States Trinus Corporation Full time
Looking for someone who is going to be responsible for obtaining and maintaining regulatory approvals for medical devices. Key Responsibilities:

  1. Represent regulatory interests on product development teams, offering insights on requirements and resolving conflicts while keeping management informed of alternatives.

  2. Review and approve protocols, reports, engineering drawings, and manufacturing documentation to ensure compliance and accuracy.

  3. Guide regulatory strategy for planning, prepare documentation for global submissions, and track milestones for regulatory approvals.

  4. Interact with regulatory agencies during submission reviews and on-site audits (e.g., US FDA, EU notified bodies).

  5. Monitor global regulations and assess their impact on projects, suggesting updates to expedite approvals.

  6. Review labeling, product changes, and documentation for compliance and consistency.

Experience:
  • Strong preference for experience with EU MDR.
  • Required training in government or trade associations.
  • Proficient in Microsoft Office and Adobe.
  • Preferred experience with product lifecycle management systems (e.g., Agile, Teamcenter) and labeling software.
  • Strong written, verbal, and interpersonal communication skills.
  • Excellent problem-solving, organizational, and analytical skills.
Education and Experience:
  • Bachelor's Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
  • 5-7 years of relevant experience.
Top Skills:
  • Experience with commercial Class II and III medical devices.
  • Previous experience with product registration and license renewals.
  • Manufacturing experience, particularly in OUS transfer solutions.
  • Familiarity with compliance initiatives and supporting FDA or EU audits.

Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE/MBE/SBE/SDB firm accredited by WBENC, NMSDC, and SBA.

Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.

At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit.

To learn more about us, please visit our website www.

Regulatory Affairs Specialist - Contract - Irvine, CA (Onsite)

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