Regulatory Affairs Consultant

ID# DCCA26578

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Provide support for nMARQ generator, cable and other non-catheter products: 

  • Develop Technical File amendments. 
  • Provide RA input for design, manufacturing and labeling changes. 
  • Represent RA in core team and project meetings, as required. 
  • Review/approve ECOs and produce RA Assessments as required. 
  • Assist in development of IDE submissions and Design Dossier amendments. 


Required education/training and/or experience: 

  • Five (5) to seven (7) years experience in the medical industry with at least five (5) years in Regulatory Affairs of Medical Devices. 
  • Bachelors Degree in Engineering, Physical or Biological science or related field of study MS degree preferred. 

Required, skills, abilities, abilities, and certifications/licenses: 

  • Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations. 
  • International clinical and regulatory experience desired. 
  • Good working relationship with regulatory authorities (Notified Bodies, FDA, etc.). 
  • Prefer experience in the cardiovascular/cardiology field.

Position Details:

Medical Device

Clinical Research

Start Date: 
8-20-2013
End Date: 
8-22-2014

IRWINDALE, CA

CON_W2

40

DCCA26578

No

No