Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

Role Description:
The Senior Program Manager, Medical Device Regulatory Affairs will lead the planning, execution, and governance of the Regulatory Affairs program across the full product lifecycle. This role focuses on program management excellence--owning important metrics, deliverables, commitments, and timelines--while coordinating with regulatory, quality, and cross-functional leaders. The roler ensures that program roadmaps align with company strategy, drive worldwide compliance, and consistently achieve outcomes such as on-time submissions, market launches, productivity gains, and fulfillment of regulatory, quality and business requirements.
Responsibilities:

• Establish and own the program roadmap, including scope, achievements, important metrics, risks, and dependencies across pre-launch and post-market activities.
• Direct program planning, prioritization, and resource coordination for Quality & Regulatory teams.
• Coordinate and track preparation, review, and delivery of regulatory dossiers to ensure timely, high-quality submissions.
• Govern post-market surveillance programs, ensuring robust tracking and reporting.
• Own program dashboards for regulatory data management, ensuring transparency, data integrity, and timely renewals.
• Coordinate program governance for document control and records management.
• Coordinate environmental and chemical compliance initiatives.
• Lead automation and digitalization projects within Regulatory & Quality.
• Establish and run regular program reviews (steerco, governance forums), providing clear status, risk/issue customer concern, and data-driven recommendations to senior leadership
• Mentor and guide project managers and team leads within the program, building strong execution rigor, ownership of important metrics, and a culture of continuous improvement.

Qualifications & Experience:

• Bachelor's degree or equivalent experience in Life Sciences, Pharmacology, Engineering, or a related field; advanced degree preferred.
• 15+ years of experience in lab, industrial, medical device and/or IVD environments.
• Solid understanding of medical device regulatory and compliance requirements.
• Demonstrated success leading complex, multi-region regulatory programs.
• Proven leadership experience in program or portfolio management.
• Excellent written, verbal, and presentation skills.
• Strong interpersonal skills along with effective planning, prioritization, and follow-through capabilities.
• Program/project management certification (e.g., PMP, PgMP, or equivalent) and/or regulatory certification such as RAC preferred.
• High adaptability, resilience, and facilitation skills; able to lead cross-functional teams, drive alignment, resolve conflicts, and deliver results under time pressure.

Skills Required