Russell Tobin ยท 2 months ago
Regulatory Project Manager
Cupertino, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$70/hr - $80/hr
8+ years expConfidential company is seeking a Regulatory Program Manager to provide regulatory and quality support for product submissions and launch readiness. The role involves collaborating with cross-functional teams to drive global product launch readiness, manage program activities, and conduct risk assessments.
ConsultingHuman ResourcesLegalStaffing Agency
Responsibilities
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
Qualification
Required
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
Experience with Design Controls and Quality Systems
Solid understanding of regulatory process for different classes of medical devices in both the US and internationally
BS/MS in Engineering, Biomedical Science or equivalent science degree
Preferred
May require occasional travel
Benefits
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
Employee discounts with preferred vendors
Company
Russell Tobin
Russell Tobin is a staffing and recruiting company that provides recruitment and staffing advisory services.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Woronowich, JD
Vice President - Search, Staffing & Embedded Partnerships
Ashley Steger
Director of Talent Acquisition and People Operations- Embedded Partnerships
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