Regulatory/Senior Regulatory Affairs Specialists (Medical Technology)
Location: Carlsbad, CA - Hybrid Schedule
Join a medical tech company that is revolutionizing surgery methods as we know them! With their deep resources and the latest technologies, there is no limit to what you can accomplish here!
*Gorgeous new "state-of-the-art" facility
*Employee stock purchase program
*Awesome company culture / work-life balance
They are looking to hire a talented and detail-oriented Regulatory Affairs Specialist and Senior Specialist…WILL THIS BE YOU!?
ABOUT THE POSITION…
In the role, you will develop submissions for domestic and international clearances for surgery products, including Alpha Informatix (AIX) technologies. Additionally, you will support daily activities such as the product design teams, change control, and post-market surveillance.
THE RIGHT CANDIDATE HAS…
- Bachelor's degree in a life science or engineering field.
- A minimum of 3 years (Specialist) or 5 years (Senior Specialist) of experience working with medical devices.
- Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485, MDD 93/42/EEC, and EU MDR.
- PMA & 510K preparation experience.
- RAC Certification preferred
- SaMD/ IEC 62304 experience a plus
WHAT YOU'LL RECEIVE…
- Attractive salary + bonus.
- Rich comprehensive benefits package.
- The ability to work remotely!
I'm interviewing NOW!