Regulatory Affairs Specialist II

Job description

Job Description

Requisition ID: 9918190102

DePuy Synthes is recruiting for a Regulatory Affairs Specialist II, located in West Chester, Pennsylvania, United States.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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 phenomenal 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 inspired to advance patient care in greater ways than either company could accomplish on its own.

In this role, you will:
·  Provide support to the Regulatory Affairs Trauma/CMF/Biomaterials Team, and have the opportunity to be part of a team responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
·  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.
·  Act as a liaison between multiple project teams and bring together registration deliverables to support product registrations and act as conduit for Q&A that may originate from cross-functional teams or Global Health authorities.
·  Assist in obtaining Certificates of Export from FDA, Certificate of Analysis, Apostille, or other applicable import/export notifications as needed
·  Support maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
·  Be 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.
·  Participate in training of business unit associates, both inside and outside of Regulatory Affairs, on country requirements
·  May involve acting as lead for implementation of new country regulations and requirements. This can include process 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.
·  Assist in development of regulatory processes and work instructions/SOPs and training material for Countries, and in the preparation of global registration dossiers to obtain product registrations in Priority /G9 and other markets worldwide.
·  Provide progress of work-plans and the status of key project deliverables
·  Assist with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required
·  Provide assistance in staying ahead of changes and proposed changes to the worldwide regulatory requirements related to company products and processes
·  Support compliance activities related to global regulations and international standards; May assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions.

Desired profile

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 3 years' experience) or Master's (minimum 2 year of experience) Degree in engineering or life sciences is required. Advanced Degree (PhD with 1-2 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) is a plus
·  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
·  Uses diverse experience to meet deadlines and be detailed orientated
·  Strong critical thinking and analytical skills are preferred
·  This job will be located in West Chester, PA and may require up to 10% travel (domestic and international)

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.

Primary Location
United States-Pennsylvania-West Chester-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Affairs
Requisition ID
9918190102