Senior Regulatory Affairs Specialist, Medical Devices
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