Regulatory Affairs Specialist

7 days ago

Irvine, California, United States Trinus Full time
Job DescriptionJob DescriptionJob Description:
The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.

Key Responsibilities:
  • Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
  • Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
  • Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
  • Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling contents and guidance on process improvement projects, based on prior experience and responses from affiliates.

Additional Skills:
  • Coursework, seminars, and/or other formal government and/or trade association training required
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
  • Good written and verbal communication skills and interpersonal relationship skills
  • Good problem-solving, organizational, analytical and critical thinking skills
  • Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
  • Solid knowledge and understanding of global regulatory requirements for new products or product changes.
  • Solid knowledge of new product development systems
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education and Experience:
  • Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
  • 5-7 years of experience required

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

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