AI Regulatory Program Manager responsible for supporting regulatory submissions for AI - driven medical software and devices. Collaborating across teams to ensure compliance and streamline regulatory processes.
About the role
- Senior Program Manager leading high-impact programs for innovative healthcare technology. Driving product development and operational excellence in medical device portfolios across global teams.
Responsibilities
- Lead large, complex programs that drive product development, lifecycle management, and global execution across multiple medical device portfolios.
- Develop and implement program and portfolio strategies that improve design efficiency, operational scalability, and product performance across global teams and manufacturing sites.
- Own all program elements—including scope, schedule, budget, resourcing, and risk management—ensuring alignment with business needs, customer expectations, and R&D objectives.
- Partner with cross-functional teams (e.g., R&D, operations, quality, marketing) to streamline processes, improve quality, and ensure successful delivery of next-generation medical device solutions.
- Influence stakeholders at all levels through clear communication of program progress, challenges, priorities, and strategic recommendations.
- Champion best-in-class program management practices, fostering collaboration, transparency, and continuous improvement across the organization.
Requirements
- 7+ years of experience leading large-scale programs or portfolios within medical devices, healthcare technology, or product development in a matrixed organization.
- Bachelor’s degree (Master’s in Engineering, Science, or related field preferred).
- PMP certification is a plus.
- demonstrated success driving complex product initiatives and enabling cross-functional teams toward shared outcomes.
- understanding of medical device product development processes, including design, engineering, quality systems, manufacturing, and commercialization.
- strong strategic thinking, problem-solving abilities, and experience with process improvement methodologies (Lean, Six Sigma, Agile, or similar).
- ability to navigate complexity, influence diverse teams, and deliver results in fast-paced environments.
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
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