Device Regulatory CMC – Manager (Contract) 793

About This Opportunity

We are representing a confidential biopharmaceutical organization seeking a Device Regulatory CMC Manager for a contract engagement. This role supports global regulatory strategy and submissions for drug-device combination products, working across development and commercial portfolios. Our talent team is looking for a regulatory professional with strong device and combination product experience to join cross-functional teams and drive CMC documentation excellence.

Responsibilities

• Review CMC sections of regulatory submissions supporting development and commercial device programs
• Contribute to global regulatory CMC strategies for commercial drug-device combination products
• Serve as the primary regulatory CMC contact for assigned products and projects on cross-functional teams including device development, quality, clinical, human factors, analytical development, and marketing
• Review device development documentation to support design controls for combination products
• Provide regulatory assessment and guidance on compliance topics including change controls and process improvement initiatives

What We're Looking For

Required Qualifications:

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life-science field
• Typically 4+ years of experience in the medical device or pharmaceutical industry
• Demonstrated experience supporting regulatory submissions and filings for combination products including autoinjectors, pre-filled pens, and/or pre-filled syringes
• Experience supporting Human Factors studies for devices and combination products
• Knowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs)
• Proficiency with regulatory guidelines from FDA, Notified Bodies, MDCG, EMA, and ISO standards
• Sound knowledge of Design Controls, cGMP, and relevant ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040)

Preferred:

• Experience with infusion systems and devices for drugs or cell therapies

Key Skills:

• Strong interpersonal and communication skills to exchange complex information and guide stakeholders
• Excellent problem-solving capabilities
• Strong planning, prioritization, and collaboration abilities across all management levels

How We Work With You

Candidates apply directly through Get A Job.ai. Our recruiting team will conduct an initial screening to understand your background and career goals. Qualified candidates will be submitted to our client for consideration. Please do not attempt to contact the client directly, as all communication and coordination will be managed through our team to ensure a professional and streamlined process.

Pay

Pay via Get A Job.ai: $75–$80/hour. This is a contract position; the actual rate will be based on skills, competencies, experience, and other job-related factors. Overtime pay will be provided in accordance with federal and state requirements.

Location: United States (remote options may be available)

Equal Employment Opportunity: Get A Job.ai is committed to providing equal employment opportunities to all applicants regardless of race, color, religion, sex, national origin, age, disability, genetics, veteran status, or any other protected characteristic under applicable law.