Device Regulatory CMC - Manager

Accountabilities

• • 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.

  Requirements

  • 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.

  Benefits

  • 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.