A leading Medical Device company are actively seeking a motivated candidate to fill their Senior Regulatory Affairs Specialist role. This is an initial 9-month contract role with opportunity to extend/ convert to FTE. This is an onsite role based in Irvine, CA working full- time standard office hours. Salary range between $45-50 /hour depending on experience.
Education and Experience Requirements:
- B.Sc. Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry) and 5-7 years of experience.
- Technical skills; Excel spreadsheet, Design history files, and International regulatory.
- Solid knowledge and understanding of global regulations relevant to Medical Devices, Class II and/or Class III devices, and new products or product changes.
- 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.