[Hiring] Regulatory Device CMC Manager @Syneos Health Careers

Role Description

The Device CMC manager will support strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for the device part of the combination device. This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.

Qualifications

• Bachelor's degree, with a preference in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another related life-science field.
• Typically requires 4 years of experience in the medical device, pharmaceutical industry or related field, or the equivalent combination of education and experience.
• Experience supporting regulatory submissions/filings for combination products, including autoinjectors, pre-filled pens, and/or pre-filled syringes.
• Experience supporting Human Factors studies for devices and combination products.
• Preferred experience with infusion systems/devices for drugs/cell therapies.

Requirements

• Strong interpersonal skills to exchange complex information with others and to guide others.
• Knowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs).
• Proficiency in regulatory (FDA, Notified Body, MDCG, EMA, ISO, etc.) guidelines.
• Strong problem-solving skills.
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.
• Strong sense of planning and prioritization, and the ability to work with all levels of management.
• Sound knowledge of Design Controls, cGMP, FDA, EMA, ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040, etc.).

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.