Johnson & Johnson MedTech is recruiting for a Regulatory Affairs Specialist, located in Oberdorf, Switzerland or Raynham, USA! 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/. Are you ready to take your career in Regulatory Affairs to the next level and make a significant impact? Join our dynamic team at Johnson & Johnson, where your expertise will play a crucial role in ensuring our innovative products meet the highest standards of safety, efficacy, and compliance. This role will work a Flex/Hybrid schedule and must be based in Switzerland, Oberdorf or within a commutable distance of US, Raynham. There is no remote option. The Regulatory Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Synthes line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., Medical Device Regulation (EU) 2017/745, IDE, 510(k) and PMA) or internal regulatory assessment documentation. The regulatory specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities with regards to compliance to applicable regulations and company policies and procedures. DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world. Key Responsibilities + Ensures compliance to the applicable regulatory and corporate standards/requirements (e.g., European Quality Standards, ISO 13485, Medical Device Regulation (EU) 2017/745, FDA Quality System Regulations). + Prepares, reviews, and submits regulatory submission to regulatory authorities. + Serves as the Regulatory Affairs representative throughout the entire medical device life cycle, including market/ product discontinuation. + Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance. + Assist with the maintenance of the regulatory database with accurate and current regulatory information. + Reviews product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance. + Provides regulatory guidance to product development teams and responds to product information requests. **Qualifications** Experience and Education + Minimum Bachelor’s degree in science or engineering required + Two to four years of prior regulatory experience in medical devices + Knowledge of applicable medical device regulations and guidance + Excellent written and oral communication skills + Ability to handle multiple tasks and be detail oriented + Knowledge of applicable medical device regulations and guidance + Knowledge of PLM systems and electronic submission preparation + Knowledge of orthopedic implants preferred + Languages: English (fluent) What you will need to succeed We are looking for a dedicated and detail-oriented individual to join our team. The ideal candidate will possess excellent organizational skills and the ability to manage multiple tasks effectively. A key component of this role will involve applying risk-benefit analysis techniques to inform decision-making. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. The anticipated base pay range for this position is $74 000 to $119 600 based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. + Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). + Employees are eligible for the following time off benefits: o Vacation – up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Application If you are interested in this position, please apply with an updated CV and Cover letter. Please send in your application as soon as possible. We reserve the rights to close the advert earlier than February, 7th. All applicants can expect feedback on the application. If you have issues applying, please use Chrome Web Browser and reset your password. If that does not help you can get more guidance and contact us from this page: https://www.careers.jnj.com/contactus-faq. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.