Device Regulatory CMC – Manager

Job not on LinkedIn

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $75 - $80 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Vertex Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1989

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.

📋 Description

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

🎯 Requirements

• 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 • 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.) • No C2C or Third-Party Vendors

🏖️ Benefits

• Overtime pay eligibility in accordance with federal and state requirements • Compensation, medical benefits, fringe benefits and other employment terms presented by the third-party agency partner upon offer