Regulatory Affairs Director

Catalyst

Home / Jobs / Regulatory Affairs Director

Regulatory Affairs Director


  St. Paul,   $150,000 - $160,000

Apply Now

  Regulatory Affairs    Permanent

Opportunity with a clinical stage Medical Devices organization pioneering within an emerging field of neuromodulation. A newly created position, you'll have the opportunity to define the strategy for taking on the regulatory challenges of global clinical trials and domestic submissions.

Primary Responsibilities

  • Supporting the ongoing clinical trials for groundbreaking novel technology from a regulatory perspective. Outlining timelines upcoming De Novo / PMA submissions.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Lead and facilitate company interactions with regulatory agencies (e.g., FDA Q-submissions).
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.

Experience Required

  • Minimum of 7 years’ experience in North American registration processes e.g. (PMA, 510(k), De Novo) with global exposure a bonus. 
  • Proven experience with new product development and successful approvals gained using with global clinical data.
  • Previous experience liaising directly with the FDA for submissions and/or audits.
  • At least a Bachelor's Degree in a Life Sciences discipline
  • Only US Citizens may be considered 

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