Team Lead, Regulatory Affairs - EMEA

Date: Aug 6, 2022

Location: Naples, FL, US, 34108

Company: Arthrex

Requisition ID: 51626 
Title: Team Lead, Regulatory Affairs - EMEA 
Division: Arthrex, Inc. (US01) 
Location: Naples, FL

 

 

 

 

Position Summary:

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Team Lead of Regulatory Affairs (RA) for the Europe, Middle East and Africa (EMEA) region.  The Regulatory Affairs Team Lead is responsible for supervising the daily operations of an International Regulatory Affairs Facilitation Team for the EMEA region to support timely regulatory registration in compliance with all applicable regulations and guidance for the commercial distribution of all products within the region.  This position is based out of the Arthrex headquarters in Naples, Florida. Relocation assistance may be available along with Arthrex’s exceptional employee benefits and work culture. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Duties and Responsibilities:

  • Supervise the Regulatory Affairs Facilitation Team for the EMEA region.
  • Ensure the timely preparation and processing of documentation required for product registration of products in applicable markets such as Certificate to Foreign Government (CFGs) and the Apostille and Legalization of required documents.
  • Collaborate and communicate with Business Unit (BU) partners and regional partners to ensure efficient and timely global product registrations and release.
  • Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
  • Prepare submission related documents for new product introductions, license renewals and product changes in the region.
  • Ensure compliance to UK and Swiss Regulatory requirements.
  • Interact with the in-country EMEA RA teams.
  • Work with international regulatory staff and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
  • Review Change Orders and assess regulatory impact of product changes on international regulatory licenses and submissions.
  • Research and respond to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.).

 

Requirements:

  • Bachelor’s Degree required, preferably in Life Sciences or Engineering.
  • Advanced Degree (MS, ME, MBA) preferred.
  • Regulatory Affairs (RAC) preferred.
  • 7 years direct experience in a Medical Device Regulatory Affairs role required.
  • Prior successful experience in Regulatory Affairs supervisory role preferred.
  • Experience in orthopedic medical device industry preferred.
  • Experience in independently preparing regulatory documentation required.
  • Experience with EMEA regulatory agencies submission process and regulatory strategy for medical devices required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


Nearest Major Market: Naples

Job Segment: Medical Device, Manager, MBA, QA, Quality Assurance, Healthcare, Management, Quality, Technology