Device Regulatory CMC - Manager in New York at Jobgether

his position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Device Regulatory CMC - Manager based in United States.

This contract role supports global regulatory CMC activities for marketed and development-stage drug-device combination products.
You will help shape regulatory strategies and ensure submissions meet applicable requirements across key global markets.
The role sits at the intersection of regulatory affairs, device development, quality, clinical, analytical, and human factors teams.
You will review technical documentation, contribute to regulatory filings, and provide guidance on product compliance and change controls.
The position offers an opportunity to work with complex combination products such as autoinjectors, pre-filled pens, and pre-filled syringes.
Success requires strong regulatory judgment, technical understanding, collaboration skills, and the ability to manage multiple priorities effectively.
This is a remote opportunity suited to a regulatory professional who thrives in a cross-functional, science-driven environment.

• Review CMC sections of regulatory submissions supporting development and commercial device programs, ensuring documentation is accurate, complete, and aligned with applicable requirements.
• Contribute to global regulatory CMC strategies for commercial drug-device combination products and support their effective execution.
• Serve as a regulatory CMC contact for assigned products and projects, providing guidance to cross-functional stakeholders.
• Collaborate with device product development, quality, clinical development, human factors, analytical development, marketing, and other relevant teams.
• Review device development documentation as needed to support design controls for drug-device combination products.
• Provide regulatory assessment and guidance on product compliance topics, including change controls and process improvement initiatives.
• Evaluate regulatory considerations across global markets and help ensure development and commercial programs incorporate applicable requirements.
• Communicate complex regulatory information clearly and provide practical guidance to stakeholders and management.
• Support planning, prioritization, and execution of regulatory activities across multiple projects and timelines.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another relevant life-science or technical discipline; equivalent education and experience may also be considered.
• Typically 4+ years of experience in the medical device, pharmaceutical, or related industry.
• Demonstrated experience supporting regulatory submissions or filings for drug-device combination products, particularly autoinjectors, pre-filled pens, and/or pre-filled syringes.
• Experience supporting Human Factors studies involving medical devices or combination products.
• Preferred experience with infusion systems or devices used for drugs or cell therapies.
• Strong knowledge of regulatory requirements for combination products and medical devices, including FDA requirements, EU MDR, and applicable GSPRs.
• Proficiency interpreting and applying guidance and standards from organizations and bodies such as the FDA, Notified Bodies, MDCG, EMA, and ISO.
• Strong working knowledge of Design Controls, cGMP, and relevant technical standards, including ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, and ISO 11040.
• Excellent interpersonal and communication skills, with the ability to exchange complex information clearly and guide stakeholders across functions and levels of management.
• Strong problem-solving, planning, prioritization, and organizational skills.
• Ability to work collaboratively in an open, clear, timely, and consistent manner within a complex, cross-functional environment.

• Remote contract opportunity based in the United States.
• Competitive compensation of $75–$80 per hour.
• Opportunity to contribute to global regulatory strategies for complex drug-device combination products.
• Exposure to development and commercial programs spanning medical device, pharmaceutical, quality, clinical, analytical, and human factors disciplines.
• Opportunity to work with internationally recognized regulatory frameworks and standards.
• Cross-functional environment with collaboration across technical and business teams.
• Potential eligibility for overtime pay in accordance with applicable federal and state requirements.
• Temporary assignment through a third-party agency partner; specific employment terms and benefits are provided by the agency upon offer.