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Regulatory Program Manager I

Cupertino, CA 95014

Posted: 02/06/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 617630 Is job remote?: Yes Country: United States

Job Description

Target Pay Rate: 45-54/hr **salary will be commensurate with experience 

Job Description:

The Post Market Surveillance Specialist is part of the post market surveillance (PMS) team supporting client's medical products. The post market team is responsible for performing the domestic and international product surveillance activities. 

In this key role of the Post Market Surveillance Specialist:
  • Be responsible for all administrative activities associated with the complaint handling process including, but not limited to, reviewing, managing and closing complaints records in the complaint handling system.
  • Work with cross functional teams such as clinical, engineering and customer service  groups to ensure product investigations are completed as well as maintain ongoing tracking and trending of complaints.
  • evaluate post market data and update risk management documentation 
  • Evaluate complaint documentation for completeness and consistency, and execute additional actions as necessary to close the complaint file.
  • Submit timely Adverse Event Reports to the US FDA, when appropriate
  • Conduct Post Market Surveillance activities to analyze post-market quality issues and trends
  • Identify potential issues to continuously improve product safety
  • Serve as the Subject Matter Expert to the Company for Complaints and Post Market Surveillance
  • Assist in the preparation and sending of post-market reports and submissions
  • Assist in different project work and process improvements as needed
Key Qualifications:
  • BS/MS degree in Engineering, Math, Statistics, science-related field, or equivalent technical experience
  • 3+ years of direct work experience in medical device quality functions, CAPA, complaint handling, or field action is preferred.
  • Thorough knowledge of FDA’s 21 CFR 820, 21 CFR 803, ISO 13485:2016, ISO 14971, MDD, EU MDR, MDSAP
  • Direct experience with receiving, evaluating, and investigating complaints
  • Direct experience with submitting Adverse Event Reports to the US FDA
  • Experience developing and implementing post market processes for new product development activities
  • Proficiency in utilizing IMDRF codes and a comprehensive clinical grasp of handling complaints
  • Ability to take initiative in an ambiguous and fast paced environment 
  • Excellent verbal and written communication skills with ability to lead meetings
  • Strong organizational, time management, and influence skills
  • Experience with risk management is highly preferred
  • Experience with high volume complaints environment

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 is an equal opportunity employer. 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 Cupertino, CA

Ready to kickstart your career in the vibrant city of Cupertino, California? This bustling tech hub, situated in the heart of Silicon Valley, offers unparalleled growth opportunities and a dynamic work environment. Home to tech giants like Apple Inc., this area boasts a unique blend of innovation, culture, and charm. Explore job opportunities near iconic landmarks like the Apple Park Visitor Center, indulge in the diverse cuisine of the local restaurants, and catch a show at The Flint Center for the Performing Arts. With proximity to picturesque parks like Memorial Park and Rancho San Antonio Preserve, Cupertino is the perfect place to balance work and leisure. Discover your next career move in this thriving community 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.