Project Leader Regulatory Affairs
Location:
Warsaw , Indiana
Posted:
April 02, 2017
Reference:
8572170131-en-us

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Project Leader, Regulatory Affairs, located in Warsaw, IN.

 

Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales.  The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products. 

 
:
 
  • Under little or no supervision, responsible for independently preparing and submitting regulatory submissions for the U.S., including 510(k)s, PMAs, PMA Supplements, coordinating IDE submissions, and interacting with regulatory agencies regarding submissions. 
 
  • Responsible for preparing original STEDs, EU technical files, design dossiers, and technical file revisions for the Global market.
 
  • Obtains approval of new products and provides regulatory requirements to help ensure efficient use of product resources. 
 
  • Reviews labeling to ensure compliance with regulatory requirements. 
 
  • Provides product information and regulatory guidance and support to project core teams including processing ECOs, providing guidance and review of promotional materials, and communicating regulatory pathways. 
 
  • Serves as a consultant and technical expert on Regulatory Affairs matters. 
 
  • Provides assistance in preparation and submission of global regulatory documents
 


Qualifications
  • A minimum of a Bachelor’s degree is required, preferably in a biological/life sciences or engineering discipline.
  • 6+ years of Regulatory Affairs experience in a regulated healthcare environment or industry; or minimum 4 years with advanced technical degree is require. 
  • Experience with US FDA Regulations and European Medical Device Directives required.
  • Experience in worldwide regulatory systems preferred.
  • Demonstrated expertise in medical device regulatory requirements and processes required.
  • Demonstrated expertise in orthopaedics and orthopaedic device regulatory requirements preferred.
  • Outstanding project management skills by demonstrated competence in managing multiple projects simultaneously required.
 

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-Indiana-Warsaw
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Affairs
Requisition ID
8572170131

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