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Prin Regulatory Affairs Spec

Irvine, CA 92617

Posted: 08/30/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 614269 Is job remote?: No Country: United States

Job Description


HM's Top Needs:
1. US and EU regulatory requirements for product modifications
2. IDE and PMA Annual Reports, IDE Supplement, PMA Supplement
3. MDD and MDR STED updates
  • regulatory assessment of change orders emphasis on US and EU, experience with MAP Agile, Familiar with ISO 13485, FDA Medical Devices Part 820 and medical Device Good Documentation Practices

 

Education Required: Bachelors 

Years’ Experience Required: 7+



Principal RA Specialist will play a key role in sustaining the current product portfolio. He/She has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions.  Sustaining regulatory responsibilities include reviewing changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. Responsibilities may include the following and other duties may be assigned.
  • Provide strategic input and guidance on regulatory requirements for product modifications
  • IDE and PMA Annual Reports, IDE and PMA Supplements, 510k, LTF, MDD and MDR STED updates and EU MDR submissions.
  • Manage multiple projects and prioritize tasks to meet project schedules
  • Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilitie
  •  
  • Minimum of 7 years of experience medical device regulatory affairs Or advanced degree with a minimum of 5 years of experience medical device regulatory affairs

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 Irvine, CA

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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.