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DePuy Synthes is recruiting for a Senior Regulatory Affairs Program Lead, 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.
Based on our site in Zuchwil we are looking for a highly committed:
SR. REGULATORY AFFAIRS PROGRAM LEAD
In this role, you will provide support to the Regulatory Affairs Trauma/CMF/Biomaterials Team, and have the opportunity to be part of a Global team responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
Responsibilities:
The Senior RA Program Lead will support global regulatory affairs activities, including but not limited to: assisting in providing regulatory expertise to new product development and sustaining engineering team's preparation and submission of regulatory documentation for product registration/licensing in US, EU, Japan, Russia/CIS, China, Brazil, AZN and other non G9 EU countries.
The individual will act as a global strategist providing liaison between multiple project teams to support product registrations. You shall act as a conduit for Q&A that may originate from cross-functional teams or Global Health authorities. You will participate in design and risk review meetings to assess products technical documentation including V&V, Biocomp, usability etc. This role requires maintaining a strong knowledge of applicable global external standards and assist in performing gap analysis / impact assessment of external standards, regulatory requirements.
The individual will assist in obtaining Certificates of Export from FDA, Certificate of Analysis, Apostille, or other applicable import/export notifications as needed. And support maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information.
Responsible for communicating design changes and introducing new products to in-country/regional Regulatory Affairs teams. May involve leading routine calls with Marketing and Regulatory leadership to discuss registration status and priorities.
You shall participate in training of business unit associates, both inside and outside of Regulatory Affairs, on country requirements and may act as a lead for implementation of new country regulations and requirements. This can include regulatory process, procedure(s) updates and training.
Work with cross-functional teams to obtain significant information and subsequent review of submission content as needed; assist in review of international product Technical Documents, marketing, and labeling materials.
Provide progress of work-plans and the status of key project deliverables
Provide assistance in staying ahead of changes and proposed changes to the worldwide regulatory requirements related to company products and processes
May assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions.
Qualifications
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:
Bachelor's (minimum 7 years’ experience) or Master’s (minimum 4 year of experience) Degree in Engineering or Life Sciences is required or Advanced Degree (PhD with 1-3 years of experience) preferred.
Strong Knowledge of ISO 13485, ISO 9001, MDR, MEDDEV, QSR, US regulatory, CE marking required. Deep understanding of Risk Management process, label and labeling, change management is desired.
Familiarity with Global Medical device Regulations for China, Japan, Brazil, AXN, and Canada preferred. Experience with Remediation activities preferred.
RAC accreditation (through RAPS) or PMP certification desired.
Strong Project Management skills required and experience with SAP, Oracle PLMs, Agile, Windchill is desirable.
Proficient in oral and written communication, and in Microsoft Office (Word, Excel, PowerPoint), with good planning and organization skills
Self-starter with an Ability to work in team environment and on problems of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
Uses diverse experience to meet deadlines and be detail orientated
Strong critical thinking and analytical skills required
Willingness to travel up to 10% of the time (domestic and international)
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.) by clicking here.
Please click on DePuy Synthes and Johnson & Johnson if you want 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
