"Caring for the world… one person at a time”inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
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. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
For the Regulatory Affairs department in Zuchwil (SO), we are looking for a Senior Regulatory Affairs Program Lead(m / f)
In this position as the Senior Regulatory Affairs Program Lead, you will be 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 Notified Bodies and regulatory authorities (e.g., Design Dossier, IDE, 510(k) and PMA) or and generation of Technical Files . The Regulatory Affairs Program Lead is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of Synthes products for compliance to regulations and company policies and procedures. Other tasks include:
- Represent regulatory affairs on product development teams by attending team meetings and providing the global regulatory plan, regulatory assessments and regulatory decisions
- Prepare regulatory documentation for Synthes devices, including Design Dossier, Technical file as well as IDE, 510(k) and PMA documentation for submission to the Food and Drug Administration (FDA). This includes the resolution of regulatory issues and questions from regulatory agencies and Notified Bodies during the pre-market product development phase
- Assist in the preparation of approval documents to support rest of world registrations. Additional activities may require notarization and legalization of documents, and requesting of Certificates to Foreign Government and Free Sale Certificates
- 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
- Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with relevant regulations and guidance
- Assist with the maintenance of the regulatory database with accurate and current regulatory information
- Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/ requirements (FDA Quality System Regulations, European Quality Standards, ISO 9001/13485, MDD, CMDCAS/CMDR, etc.)
- Attend conferences, seminars, professional meetings, and other public forums that are relevant to the regulatory interests of Synthes.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer
- BA/BS Degree preferred or equivalent
- Six to eight years of relevant regulatory experience in medical devices
- Knowledge of MDD/MDR and relevant guidance
- Knowledge of U.S. FDA medical device regulations and guidance
- Knowledge of orthopedic implants a plus
- Excellent written and oral communication skills in English and German or English and French
- Ability to handle multiple tasks and be detail oriented
If you are a creative and innovative mind passionate about medical technology and want to become part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.)
Synthes GmbH (7111)