Regulatory Project Manager

23 hours ago

Cupertino, CA, United States Pride Global Full time
Job Title: Regulatory Program Manager
Location: Cupertino, CA - Hybrid
Duration: 6+ Months with Possibility Extension
Pay Range: $70 - $80/hr on W2

Job Description:
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 collaborate closely with multiple cross-functional teams to drive global product launch readiness, including regulatory submissions, DHF preparation, and medical device policy/advocacy support. In addition, you will drive day-to-day program activities and timelines, generate and own reporting, and conduct risk assessments to meet overall program objectives.

Responsibilities include:
  • Oversee regulatory submissions, design changes, and medical device policy activities 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, regulation and policy efforts, 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 & Experience
  • BS/MS in Engineering, Biomedical Science or equivalent science degree.

Benefits Info
Pride Global offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance, and employee discounts with preferred vendors.

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