Senior Regulatory Affairs Specialist, Medical Devices

Company: Hydrafacial

Position: Senior Regulatory Affairs Specialist

Location: Long Beach, CA

Posted: January 11, 2022

Here's why you'll love this job:

  • You enjoy working in a fast-paced, deadline-driven work environment where accountability is a core value!
  • You will be working in a dynamic, never-boring company with a rapidly growing product portfolio!
  • You have a passion for learning new things and bringing ideas and strategies to the table.
  • You like to make smart decisions on your own.
  • You are a creative problem-solver with a keen eye for detail who loves a challenge!

Here's what you'll be doing: 

  • Manage multiple applications simultaneously and interface directly with regulatory bodies, agencies, distributors, and other stakeholders to resolve application issues.
  • Work on cross functional teams and communicate complex regulatory requirements and technical data in an understandable way for any audience to bring exciting new products to the market.
  • Author and compile technical documentation for submissions, licensing and re-licensing, and change reporting.
  • Research and report relevant regulations and conduct impact/gap analyses to ensure smooth implementations in assigned markets.
  • Support local partners on regulatory documentation for both compliance and importation where needed.

Here's what you'll bring to the role:  

  • 5+ years of Regulatory Affairs Experience at a Medical Device Company and/or Cosmetics Company
  • Working Knowledge of International Regulations and standards such as CFR 820, EU MDD/MDR, IEC, ISO, etc.
  • Keen communication skills including technical writing for global submission files
  • Ability to work independently and with minimal supervision
  • Ability to work in a face paced environment and manage multiple projects simultaneously
  • Familiarity with Document Control Systems, MS Office