Senior Regulatory Affairs Program Lead (DePuy Synthes) - Medical Device Business Services, Inc.

DescriptionDePuy Synthes is currently recruiting for a Senior Regulatory Affairs Program Lead.  The preferred location for this role is Warsaw, IN however candidates may also be located within a commutable distance of the DePuy Synthes offices in Raynham, MA, West Chester, PA, Palm Beach Gardens, FL, Leeds, UK, Oberdorf, SZ, or Lyon/Grenoble, FR.  This role will work a Hybrid/Flex schedule with 3 days in office each week.DePuy Synthes, the Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive orthopedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.The Senior Regulatory Affairs Program Lead will perform regulatory activities to support currently marketed devices and new product development in the DePuy Synthes VELYS Digital Surgery line of products. This role involves a multifaceted set of skills including sound regulatory judgment and cross-functional collaboration. In addition, this candidate must exhibit a high degree of independent judgment and must plan/oversee/execute projects & activities that directly impact the operational results of the business.Key Responsibilities:Under minimal supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:·         Directs and coordinates activities concerned with the submission and approval of products to government regulatory agencies.·         Coordinates the preparation and maintenance of regulatory submissions and files.·         Provides guidance to project team members regarding regulatory and compliance issues by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.·         Establishes accountability for the preparation of necessary outlines, summaries.· Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.·         Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.·         Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.·         Responsible for communicating business related issues or opportunities to next management level.·         Works with team members to determine regulatory impact of manufacturing and/or changes on products, prepare and submit applications, and the assess the impact product changes have on the status of regulatory licenses.·         Interprets regulatory requirements and determines strategies to obtain clearances and approvals.·         Independently makes decisions regarding work processes or operational plans and schedules.·         Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.QualificationsMinimum Qualifications:·         Minimum of a Bachelors level degree is required; Advanced Degree strongly preferred.·         Minimum 4+ years relevant experience in a highly regulated (MedTech/Pharma/Consumer) industry is required. Previous experience with medical devices is strongly preferred.·         Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) required.·       Demonstrated expertise in medical device regulatory requirements and processes.·         Outstanding project management skills by demonstrated competence in managing multiple projects simultaneously.· Outstanding written and oral communication skills.·         Capable of providing direction and training to junior colleagues.·         Connect by cultivating external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the SC, R&D, Clinical Affairs, and other partners.·         Shape by executing strategies developed by the Regulatory Policy Team.·         Lead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive manner.·         Deliver results for timely clearances and approvals; change tasks, process improvements for regulatory matters.Preferred:·         Experience in worldwide regulatory systems.·         Demonstrated expertise in orthopaedics and orthopaedic device regulatory requirements.Other:·         Up to 10% domestic or international travel may be required.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.For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit Field: Regulatory AffairsOrganization: Medical Device Business Services, Inc (6029)Travel: Yes, 10 % of the Time