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

Job Description

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. 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.

Responsibilities

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.

Required Education, Experience and Skills

• 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

Who We Are:

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.

US and PR Residents Only

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

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.

Search Firm Representatives Please Read Carefully

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.

Applicable to United States Positions Only: 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.

Annualized Salary Range (US)

$168,000.00 - $285,800.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

10%

Flexible Work Arrangements:

Flex Time, Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1