Director of Regulatory Affairs

12 Nov, 2020

Jobs

Director of Regulatory Affairs

Network Partners
Remote

Due to tremendous growth, Network Partners is looking for a Director of Regulatory Affairs to help continuously develop and enhance our portfolio of industry leading talent!

About Us

Network Partners is a professional services firm that helps clients complete the work necessary to provide their products to patients. Serving the medical device, pharmaceutical and biopharmaceutical industries with core competencies in Regulatory Affairs, Packaging Engineering, Labeling, Quality and Project Management. www.networkpartners.com

 

The Opportunity

Network Partners is seeking to hire an experienced Regulatory Professional to our staff that will work remotely with our client partner to drive the success of their MDR program, as well as be an asset to the growth and development of our internal team.

Key Responsibilities:

  • Identify Regulatory specific business strategies to meet the company’s annual goals
  • Manage team of direct reports, including development activities and mentoring through goals and objectives
  • Provide Regulatory Affairs Expertise and partner with Sales teams for new business development activities
  • EU MDR readiness for Class I – III devices, including gap assessments of current regulatory documentation, Device Classification Review, Technical Files/Design Dossiers
  • Project management of regulatory remediation team(s) for Class I – Class III devices

Required Skills/Qualifications

  • 10+ years of medical device company experience
  • 15+ years of full-time project management experience (preferably in a product development role) with exposure to many different medical device cross-functional groups including: Regulatory, Quality, R&D, Labeling, IT, Operations, Marketing, Supply Chain, and Legal
  • Very strong team building and management skills with a demonstrable record of strategic thinking and robust, risk-adjusted project plan development
  • Be able to communicate clearly and effectively across the program and to executive leadership

Learn more here

Job posted: 2020-11-12