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Regulatory Project Manager

Cupertino, CA 95014

Posted: 08/29/2024 Employment Type: Contract Job Category: Project Management Job Number: 612614 Is job remote?: Yes Country: United States

Job Description

Target Pay Rate: 80-100/hr **salary will be commensurate with experience 
Job Description:
The Program Manager will provide regulatory and quality support for product submissions, approvals, and launch readiness. You will work hand in hand with cross- functional teams and may provide hands-on individual contribution to meet the team’s objectives. You will be responsible for developing program timelines, tracking submission deliverables, and providing support for regulatory submissions by coordinating with various team members. You will collaborate closely with multiple cross-functional teams to drive global product launch readiness. In addition, you will drive day-to day program activities, generate and own reports and score cards, and conduct risk assessments to meet overall program objectives.

Responsibilities include:
  • Oversee regulatory submissions and approvals for portfolios of work
  • Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners
  • Communicate program status and escalate risks to a variety of stakeholders
  • Establish and manage Quality Design History File documentation timelines and successful execution across multiple cross-functional stakeholders

Key Qualifications:
  • 8+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health
  • Proven track record of driving regulatory submissions, approvals, and launches with multi-disciplinary teams
  • Outstanding communication and organizational skills. Ability to optimally manage multiple projects simultaneously
  • Excellent analytical and problem-solving capabilities, with a keen eye to detect and mitigate risks
  • Independent self-starter who thrives in ambiguous environments
  • Hands-on experience in the use of project management and reporting software

Additional Requirements:
  • Experience with Design Controls and Quality Systems
  • Solid understanding of regulatory process for different classes of medical devices in both the US and internationally
  • May require occasional travel
Education and Experience:

BS/MS in Engineering, Biomedical Science or equivalent science degree.


**CO/NY candidates may not be considered 
 

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 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.