Johnson & Johnson Careers
Requisition ID: 1905742204W
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
DePuy Synthes is recruiting for a Regulatory Specialist, located in Oberdorf, Switzerland. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. We offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two outstanding companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop creative, comprehensive solutions, we are encouraged to advance patient care in greater ways than either company could accomplish on its own.
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 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 of Synthes products for compliance to FDA regulations and company policies and procedures.
Other responsibilities may 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
- 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
- Review 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 US 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
- 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
Are you passionate about gaining experience across the entire life cycle of a product? Do you work well in a dynamic, collaborative environment? This is what you should have:
- BA/BS Degree preferred or equivalent work experience
- 3 to 5 years of prior regulatory experience in medical devices
- Good knowledge of MDR, ISO 13485
- Excellent written and oral communication skills
- Ability to handle multiple tasks and be detail oriented
- Fluency in English and a high level of German preferred
If you feel attracted by this challenge and want to be part of a successful and growing organization with excellent working conditions then please send us your online application (CV, Motivation Letter, Working References etc.)
Please click on DePuy Synthes and Johnson & Johnson if you would like to learn more about our business and check our new career channel on YouTube www.youtube.com/user/CareersAtJNJ to understand our working culture!
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. You will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and not be discriminated against on the basis of disability.
Synthes GmbH (7111)