Senior Regulatory Affairs Specialist
Location:
Raynham , Massachusetts
Posted:
February 03, 2017
Reference:
5792170110-en-us

DePuy Synthes is recruiting for a Senior Regulatory Affairs Specialist, located in Raynham, MA.
 
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.  For more information, visit www.depuysynthes.com
 
The Senior Regulatory Affairs Specialist provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches.  Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.  He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.  The Senior Regulatory Affairs Specialist helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.  The role assists in the development of best practices for Regulatory Affairs processes.
 
  • Prepare US and International regulatory submissions, including, but not limited to 510(k)’s, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, HDEs, IND/NDA Supplements, Design Dossiers/Change Notifications, and Technical Files.
  • Work with management to devise strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
  • Participate and provide guidance and support to product development teams on both US and international issues.
  • Review and approve labeling, manufacturing, marketing and clinical protocol procedures and documents.
  • Review and provide regulatory authorization for Change Orders (COs).
  • Review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments.
  • Submit Design Dossiers for up-classification of products in the EU.
  • Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.

Qualifications
  • A minimum of a Bachelor’s degree from accredited college or university is required.  A degree focused in science, biomedical engineering, medical/ scientific writing, public health administration preferred.
  • 4+ years working in regulated healthcare industry is required.  Candidates with 2+ years of practical experience will be considered if they possess an advanced degree in Regulatory Affairs or other scientific discipline.
  • Knowledge of US and European regulatory processes is required.
  • Experience in the preparation, and submission of US Regulatory files (510(k)s, PMAs) and/or European technical files and design dossiers is required.
  • Experience with Medical Device Navigation Software and Instruments and/or Medical Device Software is preferred.
  • Experience presenting at FDA meetings is preferred
  • This position is located in Raynham, MA and may require approximately 10% travel.
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Primary Location
United States-Massachusetts-Raynham
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Affairs

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