Regulatory Affairs Specialist

ID# DCNJ27157

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 

The Regulatory Affairs Specialist prepares EU and US submissions including traditional, or special 510(k)s and EU Technical Files and Design Dossiers updates/notifications. Provides regulatory support to product manufacturing transfers. Provides regulatory support for product design, manufacturing, packaging, sterilization, kitting changes and labeling changes. Coordinates project efforts with EU, Swiss and Japanese counterparts and assess international impact of product changes. Reviews and provides regulatory authorization for Engineering Change Orders (ECOs). Reviews and analyzes technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments. Works with Management to develop appropriate regulatory strategies. 

Qualifications 

  • A minimum of a Bachelor's degree is required, preferably in a scientific or related discipline. 
  • A minimum of 2+ years experience working in a Regulatory environment is required; experience preparing or assisting in submissions for Class I/II medical devices is preferred. 
  • Knowledge of US and European regulatory processes is required. 
  • Experience in the preparation or assisting in the preparation of and submission of 510(k)'s, Technical Files or Design Dossiers is required. 
  • The ability to multitask, support multiple small projects and function on a global basis interacting with US, EU and Japan resources is preferred. 
  • Must have excellent written, verbal communication and presentation skills. 
  • Must be able to communicate clearly, succinctly and effectively over the phone and in writing. 
  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive will be needed. 
  • Must be able to work in a timeline-driven environment

Position Details:

Medical Device

Scientific

Start Date: 
9-30-2013
End Date: 
9-1-2014

SOMERVILLE, NJ

Full Time

40

DCNJ27157

No

No