Johnson & Johnson Careers
Senior Regulatory Affairs Specialist
Requisition ID: 1905730457W
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 Senior Regulatory Affairs Specialist, located in Zuchwil, 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.
Your tasks as a SENIOR REGULATORY AFFAIRS SPECIALIST may include:
- Preparing regulatory documentation to support the market distribution of new and modified medical devices (510(k)/NTF) in US, Canada, and EU
- Supporting global registrations in rest of world. Review device labeling, including all graphic material
- Preparing export certificates, medical device listings, annual establishment registrations for submission to the U.S. Food and Drug Administration (FDA)
- Assisting group in maintaining regulatory database for all products. Provide support to Regulatory Manager for special projects as needed
- You will be compiling, preparing, reviewing and submitting regulatory submission to regulatory authorities
- Monitoring and submitting applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices
- Collaborate with Product Development to obtain necessary information for regulatory submissions.
- Review/approve Custom Device Requests
- Review/approve Engineering Change Requests/Notices
- Review/approve labeling: device labels, brochures, technique guides, bulletins, updates, etc.
- Review trade publications for Regulatory news (Gray Sheet, GMP Letter, etc.)
- Respond to requests for information on import detentions
- Maintain regulatory database - ongoing update of database with regulatory information
- Assist in the development and implementation of SOPs and systems to track and manage product-associated events
- Assist in the development of regulatory strategy and update strategy based upon regulatory changes
- You will provide regulatory input to product lifecycle planning
- Evaluate regulatory impact on proposed products
- Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval
- Determine and communicate submission and approval requirements
- Begin to participate in risk-benefit analysis for regulatory compliance
- Submit and review change controls to determine the level of change and consequent submission requirements
- Continue to revisit and compare regulatory outcomes with initial product concepts to advise on future actions.
- Provide training for staff on current and new regulatory requirements
- Communicate regulatory agency/industry positions within the regulatory department
- Problem-solve with and advise internal partners on regulatory issues
- Identify standards for the organization’s products
- Participate in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations
- 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:
- BS Degree in Science or Engineering required
- Four to six years related regulatory experience in medical devices or relevant medical device industry experience
- Excellent written and oral communication skills
- Excellent organizational skills preferred
- Ability to handle multiple tasks and be detail oriented
- Ability to apply risk-benefit analysis techniques
- General knowledge of Submission types and requirements
- Knowledge of clinical research, clinical operations, and nonclinical, quality, and regulatory requirements and GxPs (GCPs, GLPs, GMPs)
- Fluency in English and 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)