Principal Scientist (Director), CMC Regulatory Affairs – Medical Devices & Combination Products
Organon
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Job summary
Organon is seeking a Principal Scientist, CMC Regulatory Affairs for Medical Devices & Combination Products in the United States. This role provides strategic leadership for global regulatory activities spanning development, registration, and lifecycle management of devices and drug-device combinations.
You will lead major submissions, guide health authority interactions, and partner with Product Development, Device Engineering, Quality, and Regulatory Affairs to shape strategy and ensure
Qualifications
- Bachelor's degree or higher in engineering, pharmacy, or life sciences.
- 10+ years in Regulatory Affairs or related regulated industries.
- Experience leading global regulatory strategies for devices and combination products.
- Experience with FDA and global authorities.
Responsibilities
- Develop and lead global CMC regulatory strategies for medical devices and drug-device combination products.
- Lead major submissions and regulatory milestones.
- Engage with health authorities and manage inspections.
- Collaborate with cross-functional teams to align regulatory requirements.
Skills
Education
Job description
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
$168,000.00 - $285,800.00
Regular
Domestic
No
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%
Flex Time, Hybrid
1
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