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

Organon

. Develop and lead global CMC regulatory strategies for medical devices and drug-device combination products across all lifecycle stages .

Posted 11/3/2026full-timeUnited StatesLead💰 $168,000 - $285,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in developing and leading global regulatory strategies for medical devices and combination products, ensuring compliance with FDA and international regulations. Proven ability to influence cross-functional teams and senior leadership while managing complex regulatory submissions and lifecycle management.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentRegulatory Submissions ManagementFDA Interaction and ComplianceMedical Device and Combination Product ExpertiseRisk Management and Mitigation

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsMedical Device RegulationsCombination Product RegulationsSubmission Preparation (INDs, NDAs, BLAs, MAAs)Regulatory Impact AssessmentISO 13485 KnowledgeISO 14971 KnowledgeIEC 62366 KnowledgeClinical EvaluationPost-Market Regulatory Activities

Soft Skills

LeadershipInfluencing StakeholdersCross-Functional CollaborationCommunicationMentoring

Industry Keywords

Pharmaceutical DevelopmentRegulated Industry ExperienceGlobal Market ExpansionInspection ReadinessAudit Support

About the role

Key responsibilities & impact

Develop and lead global CMC regulatory strategies for medical devices and drug-device combination products across all lifecycle stages
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
Lead resolution of complex regulatory issues where regulations are evolving or precedent is limited
Lead regulatory strategy and execution for major submissions and regulatory 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
Ensure regulatory requirements are integrated into development plans, control strategies, and commercialization activities
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, labeling and IFU, and post-market regulatory activities
Guide teams on global requirements for Class II and Class III devices, disposable medical devices, and combination products
Ensure alignment of device constituent strategies with drug and biologic regulatory pathways
Represent Regulatory Affairs in 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
Act as a strategic partner across Product Development, Manufacturing, Quality, Clinical, Safety, Supply Chain, Commercial, and Regulatory organizations
Influence 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
Monitor evolving global regulations, standards, and guidance
Translate regulatory requirements into practical business strategies
Drive regulatory process improvements and best practices
Contribute to capability development through mentoring, training, and knowledge sharing
Represent the organization in industry forums, trade associations, and regulatory policy discussions

Requirements

What you’ll need

Bachelor's degree or higher in Engineering, Pharmacy, Pharmaceutical Sciences, Biology, Chemistry, Biomedical Engineering, Regulatory Science, Life Sciences, or 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 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
US and PR residents only
No visa sponsorship
Ability to satisfy applicable travel and credentialing requirements, including associated vaccination prerequisites

Benefits

Comp & perks

Retirement savings plan
Paid vacation and holiday time
Paid caregiver/parental and medical leave
Medical, prescription drug, dental, and vision coverage
Flexible work arrangements: Flex Time, Hybrid
Domestic relocation
Equal Opportunity Employer inclusion, innovation, and belonging culture