"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 SynthesCompanies 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.
Based in our site in Zuchwil we are looking for a highly committed
Regulatory Affairs Specialist
As a Regulatory Affairs Specialist you ensure that regulatory requirements for the approval of medical devices after product development and post market phase are met.
Your main tasks will include:
- Review of product design changes of marketed products and preparation of internal regulatory assessments for necessary regulatory activities
- Review and approve product labeling, advertising and promotional materials after evaluating compliance to the relevant European and internal regulations
- Collaboration with US and other RA partners to develop world-wide regulatory strategies to ensure timely approval of devices and continued regulatory support of marketed devices
- Communicate effectively at all levels within Regulatory as well as cross functionally with departments such as R&D, Quality, Manufacturing, and Marketing
- Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility
- Review and analyze clinical evaluations reports, market preference evaluation documents, technical protocols, data and reports generated by R&D, Quality or other related departments
- Part of cross functional teams by providing regulatory guidance in the understanding of medical device regulations
- Support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities
- A minimum of a Bachelor's degree in a Technical or Scientific discipline will be required
- 2 to 3 years practical experience (work, internship, co-op, etc.) in a medical device Regulatory Environment will be required
- Solid Knowledge of European regulations will be required
- Knowledge of US or international regulations is preferred.
- Problem solving and decision-making skills will be required
- Interpersonal skills that foster conflict resolution as it relates to technical situations will be required
- Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
- English: fluent; German is an advantage
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.) by clicking on Apply.
Synthes GmbH (7111)