Senior Regulatory Affairs Specialist

4 weeks ago


Temecula, United States SMS Staffing Inc. Full time
Job DescriptionJob DescriptionSMS Staffing Inc is Hiring Immediately for a skilled Senior Regulatory Affairs Specialist. Job Title: Senior Regulatory Affairs SpecialistJob Location: Temecula, CA, U.S.A.Job Type: Contract (possible extension)Pay: Starts at $31.00 an hourShift Structure: 8:00 am - 5:00 pm; ONSITE, Monday to Friday, 40 hours per weekAbout the Senior Regulatory Affairs Specialist Role: This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
  • Assist the strategy implementation and operations for regulatory affairs activities, product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
  • Identify opportunities for regulatory affair processes and drive changes to completion.
About You: The ideal candidate will have the following skills and experience:
  • BA Degree required
  • Must have 3-5 years of experiences in Medical Device Regulatory Affairs
  • Have working knowledge in EU MDR
  • Have working knowledge in Regulatory Change Assessment
  • Have working knowledge in US and EU medical device submissions
  • Have experience supporting internal and external inspections
  • Work cross-functionally and in a matrixed environment
  • Have experience with continuous improvement activities
Come join the SMS team It takes more than top-notch facilities, modern equipment, and innovative technologies to become our customer’s most trusted supplier. It takes people who are committed to our customer’s success and who are willing to go the extra mile to get the job done right.

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