Associate Director, Regulatory Affairs

DePuy Synthes is recruiting for an Associate Director, Regulatory Affairs for Mitek Sports and Shoulder Reconstruction business unit in Raynham, MA. DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com. This position will be responsible for partnering with R&D and Global Strategic Marketing platform leaders as well as other cross-functional team members/leaders to develop and execute global regulatory strategies to drive pipeline development and global launch excellence. Products supported are orthopedic medical devices. Primary responsibilities will include the development and execution of regulatory strategies to obtain market access for new/modified products and lifecycle management activities required to maintain existing products globally. The Associate Director is also responsible for evaluating the impact of current and emerging standards and regulations and determining the most effective and efficient strategies for obtaining or maintaining product clearances/approvals/registrations in key markets. Key Responsibilities: Act as a strategic partner with colleagues in R&D, Preclinical Research, Clinical Development, Global Strategic Marketing, Supply Chain, and Health Economics Market Access teams to develop and execute global regulatory strategies for new and existing products to assure on-time regulatory approval/clearance and post-marketing activities with a focus on strategic markets. Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products. Develop and submit US and EU regulatory filings such as Pre-submissions, 510ks, and EU MDR TDs. Partner with regional leaders on regulatory strategy and submissions to successfully obtain marketing approvals for all other markets. Lead technical writing team in IFU and manuals. Partner with regional leaders and the Regulatory Affairs Policy Intelligence team to monitor the regulatory environment globally and assess and communicate the impact of current and emerging regulations on the company's portfolio of products, define the future vision, and drive innovative thinking. Review product design, labeling, and manufacturing changes to existing products to assess the impact to safety and efficacy. Collaborate with Legal, Medical and Quality partners regarding product safety and quality issues. Contribute to risk management plans and failure mode analysis during safety signal detection. Manage, oversee, and balance resource allocation across critical projects. Provide key input for product claims and evidence support, and review and approve Advertising and Promotional materials in accordance with local regulations. Lead, inspire, and mentor RA staff members, directly or indirectly. Influence and collaborate to bring about process and technical improvements within the organization. Represent the company and influence regulations and health authority guidance through industry trade association(s) in partnership with the Policy Intelligence team. Ensure that company policies, procedures and practices are compliant with appropriate regulatory requirements. Qualifications Education: Bachelor’s degree (required) Advanced degree (preferred) Degree in a technical related discipline (preferred) Required Skills: Minimum 10 years relevant / regulated industry experience is required or 8 years with an advanced degree. Proven track record of developing and executing global regulatory strategies that align with business deliverables. Preferred Skills: Previous experience with medium and high-risk medical devices (including regulatory submissions) Previous experience with digital, electromechanical and software products. Experience working closely with and negotiating with Health Authorities. Experience working with professional and trade associations. 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. 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 www.careers.jnj.com. Primary Location United States-Massachusetts-Raynham-325 Paramount Drive Organization Medical Device Business Services, Inc (6029) Job Function Regulatory Affairs Requisition ID 2206025448W