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Senior Regulatory Affairs Specialist

Temecula, CA 92591

Posted: 04/01/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 603150 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges between $26-31/hr
 
Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs

?Skills:
  • Have working knowledge in EU MDR
  • Have working knowledge in Regulatory Change Assessment in
  • 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

Education: BA Degree Required

Duties:
  • 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, including directing development of 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 opportunity for regulatory affair processes and drive changes to completion.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Temecula, CA

Ready to advance your career in the vibrant Temecula, California area? Discover exciting job opportunities right here! Temecula, nestled in the heart of Southern California, offers a perfect blend of picturesque vineyards, historic Old Town charm, and a thriving job market. With easy access to renowned wineries, hot air balloon rides over Wine Country, and cultural attractions like the Temecula Valley Museum and the Old Town Temecula Community Theater, this region provides a unique backdrop for professional growth. Imagine enjoying delectable cuisine at local eateries, exploring art galleries, catching a show, or cheering on the local sports teams. Embrace the endless possibilities for career success and personal fulfillment in the Temecula area. Dive into our list of job opportunities today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.