Device Regulatory CMC – Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess CMC components of regulatory submissions to support both development and commercial device initiatives.

• Assist in formulating global regulatory CMC strategies for commercial drug-device combination products.

• Actively engage in cross-functional teams, collaborating with device product development, quality assurance, clinical development, human factors, analytical development, and marketing.

• Function as the main regulatory CMC liaison for assigned products and projects as necessary.

• Evaluate device development documentation to support design controls for drug-device combination products when required.

• Provide regulatory insight and guidance concerning product compliance issues, including change controls and process enhancements.

⛳️ Requirements

• A bachelor's degree is required, preferably in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or a related life-science discipline.

• Generally requires 4 years of experience within the medical device or pharmaceutical industry, or a relevant combination of education and experience.

• Experience in supporting regulatory submissions/filings for combination products, including autoinjectors, pre-filled pens, and/or pre-filled syringes is essential.

• Background in assisting Human Factors studies for devices and combination products is preferred.

• Experience with infusion systems/devices for drugs/cell therapies is advantageous.

• Excellent interpersonal skills to convey complex information and mentor others effectively.

• Familiarity with regulatory requirements for combination products and devices (FDA, EU MDR, GSPRs).

• Proficient understanding of regulatory guidelines (FDA, Notified Body, MDCG, EMA, ISO, etc.).

• Strong analytical and problem-solving abilities.

• Capacity to collaborate and communicate in an open, clear, thorough, timely, and consistent manner.

• A well-developed sense of planning and prioritization, with the capability to work alongside all management levels.

• Comprehensive knowledge of Design Controls, cGMP, FDA, EMA, and ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040, etc.).

• No C2C or third-party vendors are accepted.

🏝️ Benefits

• Eligibility for overtime pay in accordance with federal and state regulations.

• Compensation, medical benefits, fringe benefits, and other employment terms will be provided by the third-party agency partner upon offer.