Exton Senior Specialist, Regulatory Affairs, Medical Devices PA 19341

Job description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity. Who We Are: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job Summary The Regulatory Affairs Senior Specialist is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, Post Market Submissions, China NMPA Registrations, Technical Documentation for CE Marking, technical packages.