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

📋 Description

• Evaluate CMC components of regulatory submissions that support both development and commercial device initiatives.

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

• Engage in cross-functional teams that include device product development, quality assurance, clinical development, human factors, analytical development, and marketing.

• Act as the main regulatory CMC point of contact for assigned products and projects when necessary.

• Assess device development documentation that supports design controls for drug-device combination products.

• Provide regulatory evaluation and advice on product compliance issues, including change controls and process enhancements.

⛳️ Requirements

• A Bachelor's degree, ideally in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another related life-science discipline.

• Generally requires 4 years of experience in the medical device or pharmaceutical industry, or a comparable mix of education and experience.

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

• Background in supporting Human Factors studies for devices and combination products.

• Understanding of combination product and device regulatory standards, including those set by FDA, EU MDR, and GSPRs.

• Proficiency in regulatory guidelines from FDA, Notified Body, MDCG, EMA, ISO, and others.

• Familiarity with Design Controls, cGMP, and regulatory standards from FDA, EMA, and ISO, such as ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, and ISO 11040.

• Excellent interpersonal, problem-solving, collaboration, communication, planning, and prioritization abilities.

• Capability to interact effectively with all management levels.

• No C2C or third-party vendors.

🏝️ Benefits

• Eligible for overtime compensation in line with federal and state regulations.

• Details regarding compensation, medical benefits, fringe benefits, and other employment conditions will be provided by the third-party agency partner upon offer.