Sr. Regulatory Affairs Associate Director/Consultant-Medical Device

Company: System One
Location: King Of Prussia
Posted on: February 25, 2021

Job Description:

Sr. Regulatory Affairs Associate Director/Consultant-Medical Device Job Title: Sr. Manager/Associate Director Regulatory Affairs-Medical Device Location: 100% Remote Start Date: Immediate Responsibilities :

• Acting head of Regulatory and Quality Assurance
• Short term, this role will focus on the primary duty of overseeing implementation of Medical Device Regulations (MDR 2017/745).
• Own the process of updating the Technical File to conform to the MDR .
• Oversight of the 5-year shelf-life testing of company's product.
• Spearhead regulatory ownership with internal/external manufacturing. Requirements:
  • Typically, 10+ years' experience in the medical device industry.
  • Management and leadership experience at project/operational level, experience with strategic initiatives/issues.
  • 10+ years medical device regulatory affairs experience with regulatory processes including direct contact with regulatory agencies; full knowledge of FDA 510(k), EU CE Clearance & notified body regulations and guidelines, and the ability to provide interpretations of the information to others.
  • Strong knowledge of current MDR 2017/745 Regulations vs MDD 93/42/EEC
  • Experience with developing and implementing competitive regulatory strategies.
  • Solid understanding of dossier requirements for 510 (k), PMA, CTA, Design Master File, ISO 13485 and 21 CFR 820.
  • Ability to strategically interpret and respond to requests from regulatory agencies.
  • Demonstrated track record in securing product approvals and maintaining a complex portfolio.
  • Direct experience of leading regulatory authority meetings in different phases of drug development.
  • Proven leadership skills in a cross-functional team environment. International experiences a plus.
  • Ability to interact externally and internally to support global business strategy.

Keywords: System One, Philadelphia , Sr. Regulatory Affairs Associate Director/Consultant-Medical Device, Executive , King Of Prussia, Pennsylvania