Regulatory Change Management Program Manager, Vice President
State Street
Senior Program Manager – Product Compliance Projects
Philips
full-time
Posted on:
Location Type: Hybrid
Location: Murrysville • Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $124,000 - $199,000 per year
Job Level
Senior
Tech Stack
PMP
About the role
- Lead large-scale compliance and remediation programs tied to EU-MDR (European Medical Device Regulation) and U.S. Consent Decree initiatives.
- Develop and execute program strategies that drive simplification, standardization, and product quality across global manufacturing sites.
- Oversee complex project portfolios, by owning and aligning scope, schedule, and risk management with business and R&D goals.
- Partner with cross-functional teams to integrate audit findings, enhance Quality Systems, and improve CAPA and design control processes.
- Serve as a key voice within the PMO, communicating program status, risks, and results to senior leadership and stakeholders.
Requirements
- A minimum of 7+ years of experience leading program or portfolio management within product development, quality, or operations in a matrixed environment.
- A Bachelor’s degree is required or Master’s in Engineering, Science, or related field preferred (PMP certification is a plus).
- Proven success in problem solving and process improvement methodologies (Lean, Six Sigma, or Hoshin) and managing compliance-driven programs (e.g., EU-MDR, consent decrees, or recalls).
- Strong understanding of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR 803/806/820, EU-MDR) and medical device development processes.
- Technical depth of electromechanical design, design history file requirements, and CAPA management is a plus.
- A collaborative leadership style with the ability to navigate complex challenges, influence stakeholders, and drive measurable impact.
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
program managementportfolio managementprocess improvementLeanSix SigmaHoshinelectromechanical designCAPA managementQuality System Regulationsdesign history file
Soft skills
collaborative leadershipproblem solvinginfluencing stakeholdersnavigating complex challengescommunication
Certifications
PMPBachelor’s degreeMaster’s in EngineeringMaster’s in Science
