Principal Scientist, CMC Regulatory Affairs – Medical Devices & Combination Products

The Principal Scientist, CMC Regulatory Affairs – Medical Devices & Combination Products provides strategic leadership and execution for global regulatory activities supporting medical devices, drug-device combination products, and associated CMC regulatory programs across development, registration, commercialization, and lifecycle management. This role serves as the senior regulatory lead for complex device and combination product programs, shaping global regulatory strategy, influencing development and manufacturing decisions, and ensuring successful regulatory outcomes that support business objectives, patient access, and uninterrupted product supply. The Director reports to the Executive Director, and partners closely with Product Development, Device Engineering, Pharmaceutical Development, Quality, Manufacturing, Supply Chain, Clinical, Safety, Commercial, and Global Regulatory Affairs organizations to navigate complex and evolving regulatory requirements while advancing innovative products through the global regulatory landscape.

This position requires a strategic thinker who can influence senior stakeholders, resolve complex regulatory challenges, and lead regulatory approaches where precedent may be limited or regulatory expectations are evolving.

Regulatory Strategy Leadership

• →Develop and lead global CMC regulatory strategies for medical devices and drug-device combination products across all stages of the product lifecycle.
• →Drive regulatory approaches supporting development, clinical investigation, registration, commercialization, lifecycle management, and patient supply continuity.
• →Provide strategic regulatory guidance for complex device technologies, delivery systems, connected devices, and combination products.
• →Anticipate regulatory risks and develop mitigation strategies to support program objectives and business priorities.
• →Lead resolution of complex regulatory issues where regulations are evolving or established regulatory precedent is limited.

Global Regulatory Execution

• →Lead regulatory strategy and execution for major submissions and regulatory milestones, including:
  • →INDs and CTAs
  • →NDAs, BLAs, and MAAs
  • →Device constituent documentation
  • →Notified Body submissions and opinions
  • →Significant post-approval changes
  • →Global lifecycle management submissions
• →Oversee regulatory impact assessments for manufacturing, design, process, packaging, labeling, and device constituent changes.
• →Ensure regulatory requirements are integrated into development plans, control strategies, and commercialization activities.

Medical Device & Combination Product Leadership

• →Serve as the primary regulatory expert for medical device and combination product requirements.
• →Provide strategic oversight for:
  • →Design controls
  • →Risk management
  • →Human factors engineering
  • →Usability validation
  • →Clinical and performance evaluations
  • →Device verification and validation activities
  • →Labeling and Instructions for Use (IFU)
  • →Post-market regulatory activities
• →Guide teams on global requirements applicable to Class II and Class III devices, disposable medical devices, and combination products.
• →Ensure alignment of device constituent strategies with drug and biologic regulatory pathways.

Health Authority Engagement

• →Represent Regulatory Affairs during interactions with FDA, EMA, Health Canada, Notified Bodies, and other global regulatory agencies.
• →Lead strategy development, briefing preparation, agency responses, and regulatory negotiations.
• →Provide leadership during inspections, audits, and regulatory inquiries involving device and combination product requirements.
• →Influence regulatory approaches through effective engagement with health authorities and industry stakeholders.

Cross-Functional Leadership

• →Act as a strategic partner across Product Development, Manufacturing, Quality, Clinical, Safety, Supply Chain, Commercial, and Regulatory organizations.
• →Influence key development and lifecycle decisions through expert interpretation of regulatory requirements and business impact.
• →Drive alignment across global, regional, and functional stakeholders.
• →Communicate regulatory risks, opportunities, timelines, and decision points to senior leadership.
• →Lead cross-functional teams to achieve critical regulatory milestones and business objectives.

Regulatory Excellence & Capability Building

• →Monitor evolving global regulations, standards, and guidance impacting medical devices and combination products.
• →Translate regulatory requirements into practical, executable business strategies.
• →Drive regulatory process improvements and best practices.
• →Contribute to organizational capability development through mentoring, training, and knowledge sharing.
• →Represent the organization in industry forums, trade associations, and regulatory policy discussions as appropriate.

• Bachelor's degree or higher in Engineering, Pharmacy, Pharmaceutical Sciences, Biology, Chemistry, Biomedical Engineering, Regulatory Science, Life Sciences, and Related scientific discipline. Advanced degree preferred (MS, PharmD, PhD, MBA).
• At least 10 years of experience in Regulatory Affairs, pharmaceutical development, medical devices, combination products, or a related regulated industry.
• Significant experience leading global regulatory strategies for medical devices and combination products.
• Demonstrated success supporting products from development through registration and lifecycle management.
• Experience leading regulatory activities associated with FDA and global regulatory authorities.
• Experience supporting major submissions including NDAs, BLAs, MAAs, INDs, CTAs, and significant post-approval changes.
• Proven success influencing senior leaders and cross-functional stakeholders in complex matrix organizations.
• Experience managing multiple high-priority regulatory programs simultaneously.
• Experience with biologic, pharmaceutical, and combination product portfolios.
• Experience supporting global market expansion initiatives.
• Experience interacting with Notified Bodies and European regulatory frameworks.
• Knowledge of ISO 13485, ISO 14971, IEC 62366, and applicable combination product standards.
• Experience leading inspection readiness, audit support, and regulatory remediation activities.
• Participation in industry trade groups or regulatory policy initiatives.

Secondary Language(s) Job Description

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

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