Job Title: Regulatory Affairs Director
Location: San Antonio, TX
Salary: $140K - $160K+ depending on experience, plus 25% bonus
Skills: Regulatory Affairs, Management, Medical Devices, FDA
About Company / Opportunity:
Join our cutting-edge medical devices company headquartered in San Antonio, TX! We are leaders in regenerative medicine, and hiring a talented Regulatory Affairs Director to lead and drive innovation within our growing team.
As our Regulatory Affairs Director, you will be the driving force behind our regulatory strategies, ensuring compliance with FDA, state requirements, and AATB Standards. You will lead internal and external audit programs, serve as the primary regulatory liaison, manage state license applications and renewals, and oversee the unique device identifiers (UDI) program. Collaborating closely with product development and other internal teams, you will help us meet project timelines and drive our mission forward.
Key Responsibilities:
- Manage direct reports, including establishing and monitoring annual goals, conducting performance reviews, creating performance improvement plans, and interviewing and hiring staff.
- Develop and implement regulatory strategies.
- Act as the primary contact for regulatory agencies.
- Manage the supplies management program and revise procedures according to FDA guidelines.
- Review validation and verification plans and protocols.
- Maintain up-to-date knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, and AATB standards.
Must-Have Skills:
- Bachelor’s degree in biology, biomedical sciences, or a related field.
- 5+ years of regulatory experience in an FDA-regulated environment.
- Experience in the medical devices industry.
- Strong management skills.
- Knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and other industry regulations.
Nice to Have:
