Regulatory Device CMC Manager (EMEA or US based)

About the role

The Device CMC Manager will support regulatory strategies for marketed and development combination products, focusing on the device component. This role prepares and submits CMC documentation and provides regulatory guidance to cross‑functional teams.

Key responsibilities

• Prepare and submit regulatory CMC documentation for device parts of combination products.
• Provide regulatory support and guidance to ensure global requirements are incorporated into development and commercial programs.
• Support human factors studies and infusion system/device projects for drugs and cell therapies.

Required profile

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs or related field.
• Typically 4 years of experience in medical device or pharmaceutical industry, including regulatory submissions for combination products such as autoinjectors, pre‑filled pens or syringes.

Required skills

• Knowledge of FDA, EU MDR, GSPRs, EMA, Notified Body, MDCG and ISO regulatory guidelines.
• Understanding of design controls, cGMP, ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040.
• Strong problem‑solving, planning and prioritization abilities, and excellent interpersonal communication.