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

Organon•Florham Park, NJ

2d•$168,000 - $285,800•Hybrid

About The Position

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. The role serves as the senior regulatory lead for complex device and combination product programs, shaping global regulatory strategy, influencing development and manufacturing decisions, and supporting regulatory outcomes that advance business objectives, patient access, and uninterrupted product supply. The position partners closely with Product Development, Device Engineering, Pharmaceutical Development, Quality, Manufacturing, Supply Chain, Clinical, Safety, Commercial, and Global Regulatory Affairs organizations. It requires strategic judgment, the ability to influence senior stakeholders, and leadership in resolving complex regulatory challenges where precedent may be limited or expectations are evolving. The role leads global CMC regulatory strategies and execution for medical devices and combination products, including major submissions, regulatory milestones, manufacturing and design change assessments, and health authority interactions. It provides regulatory expertise across device requirements, including design controls, risk management, human factors, usability validation, clinical and performance evaluations, verification and validation, labeling, and post-market activities. The position also drives cross-functional alignment, communicates regulatory risks and decisions to senior leadership, monitors changing requirements, improves regulatory processes, and contributes to organizational capability through mentoring, training, and knowledge sharing. Organon is a global healthcare company focused on women’s health, biosimilars, and a diverse portfolio of health solutions. The position is listed as hybrid with flexible work arrangements and requires 10% travel. Relocation is domestic; visa sponsorship is not available.

Requirements

Bachelor’s degree or higher in Engineering, Pharmacy, Pharmaceutical Sciences, Biology, Chemistry, Biomedical Engineering, Regulatory Science, Life Sciences, or a related scientific discipline.
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 involving FDA and global regulatory authorities.
Experience supporting major submissions, including NDAs, BLAs, MAAs, INDs, CTAs, and significant post-approval changes.
Proven ability to influence 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.

Nice To Haves

Advanced degree (MS, PharmD, PhD, or MBA).
Participation in industry trade groups or regulatory policy initiatives.

Responsibilities

Develop and lead global CMC regulatory strategies for medical devices and drug-device combination products throughout the product lifecycle.
Drive regulatory approaches for development, clinical investigation, registration, commercialization, lifecycle management, and continuity of patient supply.
Provide strategic regulatory guidance for complex device technologies, delivery systems, connected devices, and combination products.
Anticipate regulatory risks, develop mitigation strategies, and lead resolution of complex issues where requirements or precedent are evolving.
Lead strategy and execution for major submissions and milestones, including INDs, CTAs, NDAs, BLAs, MAAs, device constituent documentation, Notified Body submissions and opinions, significant post-approval changes, and global lifecycle management submissions.
Oversee regulatory impact assessments for manufacturing, design, process, packaging, labeling, and device constituent changes.
Integrate regulatory requirements into development plans, control strategies, and commercialization activities.
Serve as the primary regulatory expert for medical device and combination product requirements, including design controls, risk management, human factors, usability validation, evaluations, verification and validation, labeling and IFUs, and post-market activities.
Guide teams on global requirements for Class II and Class III devices, disposable medical devices, and combination products, and align device constituent strategies with drug and biologic pathways.
Represent Regulatory Affairs in interactions with FDA, EMA, Health Canada, Notified Bodies, and other global agencies.
Lead agency engagement strategy, briefing preparation, responses, and regulatory negotiations.
Provide leadership during inspections, audits, and regulatory inquiries involving device and combination product requirements.
Partner across functional and regional teams, influence development and lifecycle decisions, and drive alignment on regulatory requirements and business impact.
Communicate regulatory risks, opportunities, timelines, and decision points to senior leadership and lead cross-functional teams toward regulatory milestones and business objectives.
Monitor evolving global regulations, standards, and guidance, and translate requirements into practical business strategies.
Drive regulatory process improvements and best practices.
Support organizational capability development through mentoring, training, and knowledge sharing.
Represent the organization in industry forums, trade associations, and regulatory policy discussions as appropriate.