Regulatory Affairs Specialist II – Spine
Location:
Raynham , Massachusetts
Posted:
February 08, 2017
Reference:
6408170120-en-us

DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II – Spine, 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.  To learn more, visit www.depuysynthes.com
 
 
:
  • 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 Engineering Change Orders (ECOs).
  • 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 is required, scientific discipline preferred.
  • Must have 2+ years working in medical device or regulated industry.  Candidates with <2 years of practical experience who currently possess an advanced degree in Regulatory Affairs will also be considered.
  • Knowledge of US and European regulatory processes is required.
  • Experience in the preparation, and submission of US Regulatory files (510(k)s, PMAs) as well as European technical files and design dossiers is preferred.
  • Experience with Medical Device Navigation Software and Instruments and/or Medical Device Software is preferred.
  • Must have excellent written, verbal communication and presentation skills.
     
    This position will be located in Raynham, MA, and may require up to 10% domestic/international travel.
     
    BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
     

Primary Location
United States-Massachusetts-Raynham
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Affairs

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

Know someone who would be interested in this job? Share it with your network.