Director, Regulatory Affairs

Regulatory Affairs Group

Regulatory Affairs

People Leader

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

We are searching for the best talent for a
Director, Regulatory Affairs to join our Orthopaedics team located in
Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA.

The Director, Regulatory Affairs is responsible for setting regulatory strategy, and in partnership with cross-functional teams, driving excellence in product innovation, launch and portfolio management. This position is also responsible for providing direction and leadership to the Regulatory Staff in the development and implementation of global regulatory strategies and processes to assure timely commercialization of products in key markets in compliance with current and appropriate worldwide regulatory expectations.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Leads and manages activities concerned with the submission and approval products to government regulatory agencies. Develops world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
• Administers Regulatory Affairs operations including setting strategic direction and communicates business goals and objectives.
• Oversees the preparation and maintenance of regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of orthopaedic products, including Class III devices.

• Defines the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget
• Partners with R&D, Quality, Supply Chain, Global Strategic Marketing leaders and other cross-functional leaders to develop and implement strategy for pipeline development and global launch excellence
• Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages, oversees and balances resource allocation across critical projects; and is responsible for regulatory aspects of product lifecycle management
• Lead and develop Regulatory staff to become future leaders
• Partners with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's research and development programs to management
• Establish and ensure deployment of learning initiatives and training of cross functional partners on current and emerging regulatory and related requirements.
• Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies
• Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements
• Assures timely regulatory clearances for key product launches in all key markets and assesses the current state of the department (organizational structure, competencies and skills) and implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives.
• Inspires, motivates and communicates vision to regulatory associates, peers.
• Identify and assess external innovation opportunities connected to the area of responsibility– both screening & technical due diligence (or…