Zuchwil, CHE
26 days ago
Specialist II Regulatory Affairs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job Category:** Professional **All Job Posting Locations:** Zuchwil, Switzerland **Job Description:** **About MedTech** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **About Orthopaedics** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **We are searching for the best talent for our Specialist II Regulatory Affairs position, located in Zuchwil, Switzerland.** **You will be responsible for:** + Assist by providing knowledge in implementing compliance with regulations to enable products that are developed, manufactured, or distributed meet regulatory agency requirements. + Apply functional analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market. + Contribute on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets. + Advise product development teams on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process. + Carry out the detailed regulatory submissions required for new and existing product approvals and registrations. + Coordinate Regulatory Affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports to support internal and external audits. + Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. **Qualifications / Requirements:** + Minimum 2 years experience in Regulatory Affairs in Medical Devices or Pharma + Engineering or Scientific education, PhD preferred + Good command of English, German and/or French are a plus + Strong communication skills + Teamplayer + Ability to work independently with little supervision
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