Senior Regulatory Affairs Specialist

DePuy Synthes, Inc. is currently recruiting for a Senior Regulatory Affairs Specialist to support Life Cycle Management and New Product Development. The preferred position location is Raynham, MA however remote work options in the US may be considered on a case-by-case basis and if approved by the company. 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. Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow. The Senior Regulatory Affairs Specialist will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Sports Medicine and Shoulder Reconstruction line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business. Position Duties and Responsibilities Act as RA lead on multi-platform LCM and NPD projects with varying complexities. Support project teams by defining regulatory requirements to achieve compliance. Work with project team to identify and address critical path or road block issues. Create robust global regulatory strategies. Ensure changes are effectively communicated to global partners for registration impact. Ensure project plans and deliverables are compliant with appropriate design control procedures and other global regulation requirements as applicable. Compiles regulatory submissions, filing amendments and correspondence with US and EU regulatory authorities. Interact with regulatory agency personnel to expedite approvals of pending application and to resolve regulatory matters. Support International team with product re-registration. Communicate effectively with Management. Participates in process improvement and corporate initiatives as appropriate. Support various audits. Maintains knowledge of current applicable regulations and guidance documents. Maintains the highest levels of professionalism, ethics and compliance at all times. Qualifications A minimum BA/BS Degree with at least 5 years of regulated medical device industry experience (or related) Knowledge of orthopedic implants a plus Knowledge of U.S. FDA and EU MDD & MDR regulation and guidance is required Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus Strong problem-solving skills and the ability to provide efficient escalation of issues to the appropriate accountable part. Familiarity with electronic submission preparation a plus Excellent written and oral communication skills Ability to handle multiple tasks and be detail oriented This position is located in Raynham, MA and may require up to 10% travel, domestic and/or international. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. The base pay range for this position is $83k to midpoint $116K. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefits 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. Primary Location United States--- Other Locations United States-Massachusetts-Raynham Organization Medical Device Business Services, Inc (6029) Job Function Regulatory Affairs Requisition ID 2206000752W