Regulatory Affairs Coordinator

A large medical device company in Irvine, CA is looking for a Regulatory Affairs Coordinator to provide administrative support to ensure operation of regulatory activities and compliance with industry standards. Their responsibilities will include but are not limited to:
- Supporting the regulatory department as a training coordinator and a records coordinator
- Open / understand purchase orders and timelines
- Assist with the documentation of technical FDA documents
- Prepare, review, and run team meetings
- Track and monitor regulatory submissions and approvals, ensuring timely follow-up and documentation.
- Liaise with internal departments and external partners to gather necessary information for regulatory submissions.
- Prepare and distribute regulatory reports, summaries, and presentations.
- Assist in the preparation of responses to regulatory inquiries and audits.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:


Required Skills & Experience

Experience in regulatory affairs or a similar administrative role coming from a medical device/biotech/pharmaceutical company
Strong organizational and time management skills.
Excellent written and verbal communication skills.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Bachelor's Degree


Nice to Have Skills & Experience

Experience working in the medical device industry


Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.