Senior Manager Of Regulatory Affairs

Chicago  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

A world leading Medical Device company are on the look out for a Senior Reg Affairs Manager.

This position will focus on U.S. regulatory affairs as it relates to medical device, OTC drug, and other product development with an emphasis on 510(k) submissions, plus unique device identification, clinical study and testing review, medical device and OTC drug manufacturing, and regulatory aspects of medical supply product outsourcing to contract manufacturers.

Responsibilities include:
  • Responsible for review and oversight of all 510(k) submissions to FDA
  • Responsible for oversight of all labeling and advertising/promotional activities for Medline products
  • Interpret laws, regulations and guidance and assess application to company business units and products, ensuring development of appropriate policies and procedures for compliance
  • Responsible for review of various protocols and reports, including stability/shelf life testing, biocompatibility testing, and various testing done for claim substantiation
  • Guide and influence product divisions in decisions concerning primarily medical device, but also OTC drug/cosmetic and nutritional product development and promotion, including scientific and clinical considerations
  • Initiate and maintain appropriate communication within the RA department and with business units and other functions within the company
  • Provide direct supervision of individuals including mentoring and performance management
  • Interact with regulators, trade associations, and external customers as a representative of Medline
  • Reports directly to VP, Regulatory Affairs
Desired Skills and Experience

Requirements
  • Five years of experience in the management of Regulatory Affairs personnel
  • Past experience in Quality Assurance helpful but not required
  • Bachelor's degree; Master's degree desirable
  • Sound basis of scientific knowledge in multiple areas
  • Expert knowledge of FDA laws and regulations, and experience in interpretation and application
  • Additional knowledge of FTC, CPSC, and EPA regulations a plus
  • Experience in negotiating the submission process for 510(k)'s with regulatory authorities, including verbal and written communications and face-to-face meetings
  • Excellent written and verbal communication, presentation, and facilitation skills
  • Risk identification and problem solving skills


To find out more about Real please visit www.realstaffing.com
Start date
10/2013
From
Real Staffing
Published at
19.09.2013
Project ID:
601074
Contract type
Permanent
To apply to this project you must log in.
Register