Senior Regulatory Affairs Manager

Catalyst

Home / Jobs / Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager


  San Antonio, Texas   $150,000 - $175,000

Apply Now

  Regulatory Affairs    Permanent

Opportunity with an established Class III medical device organization in near San Antonio, TX who have been going through some recent growing pains, and looking for a seasoned regulatory affairs professional who wants to drive new product submissions and overall regulatory process improvement for some pretty cool technology!

Main Responsibilities

  • Primary responsibilities of the successful candidate include supporting the International Registration Team in managing, implementing, maintaining and improving the Company’s Texas Regulatory Affairs procedures and objectives.
  • Manage 3 experienced Regulatory specialists through new product submissions and global registrations of Class III devices.
  • This will include working together with staff across functions and across sites in the organization. 
  • Autonomously shape the regulatory function how you see fit.

Suggested Experience Required
 

  • Minimum of 7 years’ experience in North American registration processes e.g. (PMA, 510(k)) with U.S.FDA Class III and II medical devices regulatory affairs within cardiovascular.
  • Proven experience with U.S. FDA regulated Class III cardiovascular devices
  • Previous team leadership experience.
  • Thorough knowledge of U.S. FDA and safety guidelines related to Class III & II medical devices.
  • Bachelor’s Degree in Engineering or Life Sciences

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Callum.Sparkes

  Apply with Linkedin   Apply with Indeed