Regulatory Affairs Specialist - Johnson & Johnson - located in Switzerland or United States

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 th...