Director, Regulatory Affairs

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
People Leader

All Job Posting Locations:
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

Job Description:

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.

Purpose:

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.

Responsibilities include:

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, Qual...