What are the responsibilities and job description for the Regulatory Affairs Specialist position at ACE Partners?
Regulatory Affairs Specialist
Irvine, CA | On-Site
I’m currently partnering with an innovative medical device company developing next-generation technologies in the cardiac space, and they’re looking to add a Regulatory Affairs Specialist to their growing team in Irvine.
This is a strong opportunity for someone who enjoys working in a fast-paced, collaborative environment and wants direct exposure to complex Class III regulatory submissions and product development activities.
Key areas of focus include:
- IDE & PMA submissions
- FDA and EU regulatory activities
- Technical documentation & design history files
- Cross-functional support across R&D, Quality, and Engineering
- Regulatory strategy for new and existing products
- Direct interaction with FDA and notified bodies
What they’re looking for:
- 3 years of medical device regulatory affairs experience
- Hands-on experience with IDE/PMA submissions
- Strong understanding of FDA regulations and quality systems
- Experience supporting Class III devices preferred
- Ability to thrive in a highly collaborative environment
The team is growing, the technology is genuinely interesting, and the role offers strong visibility and career progression within a cutting-edge device company.
If you’d be interested in learning more, feel free to message me directly.