Senior Regulatory Affairs Specialist, Medical Devices

Regulatory Affairs Long Beach, California


Description

Position at The HydraFacial Company

Are you a detailed oriented logical thinker that can understand and navigate challenging regulations? If you love exploring regulations around the world, working with world class cross functional teams to fulfill regulatory requirements and bring exciting new products to the world, then we’ve got the job for you! HydraFacial is currently looking for a Regulatory Affairs Specialist to join our team of regulatory pros. You will take the lead in helping to bring new products to market and ensure we’re on top of all the dynamic regulations globally. Apply with us today!

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

What else can you expect with HydraFacial?

PERKS! We proudly offer full health benefits, that’s medical, dental, vision, FSAs, HSAs, Accident Insurance, and even Pet Insurance for your furry family to name a few. We also provide Basic Life/AD&D and Long-Term Disability coverage at no cost to you! Top these benefits off with an Employee Stock Purchase Plan. A 401(K) plan with an Employer Match because your retirement is just as important to us. The best part about it, you will be fully vested immediately!

Every person here is a key player in our success. We are firm believers in making the little things count each day, so that the big things will follow. If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.

We mean it when we say you’ll love this role!