Regulatory Affairs Specialist

Catalyst

Home / Jobs / Regulatory Affairs Specialist

Regulatory Affairs Specialist


  Cumming, Georgia   $100,000 - $125,000

Apply Now

  Regulatory Affairs    Permanent

Opportunity to join a Class III Medical Device organization that manufacture complex life-saving cardiovascular devices. Having acquired competitors with equally-as-cool-tech, they're increasing their regulatory capacity with people motivated to advance their career and help battle coronary disease!

Key Responsibilities 

  • Participating in defining regulatory strategies and submission activities (510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian License, international registrations for complex new product development activities in the Class II/III space.
  • Teaming up with global partners and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products.
  • Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address questions from regulatory agencies.

Experience Required

  • 1-3 years' in a Regulatory Affairs position, with previous Class III device experience.
  • Motivated to work on international submissions, new product submissions (IDEs & PMAs) and EU MDR transition.
  • Attention to detail, team player, and proven ability to work remotely.

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