Hybrid Senior Program Manager – Product Compliance Projects

Posted 3 weeks ago

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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

Job title

Senior Program Manager – Product Compliance Projects

Job type

Experience level

Senior

Salary

$124,000 - $199,000 per year

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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