The KYDA Partners team is seeking a Director Regulatory Affairs for a growing Biotechnology company based in San Antonio, TX. Reporting into the GM you will be responsible for overseeing all regulatory matters including; regulatory framework, submissions, and functions to ensure that the quality management system and operational functions are compliant with FDA and state requirements, AATB Standards, and other applicable regulations.
Duties & Responsibilities:
- Create and implement regulatory strategies and solutions to ensure compliance with FDA and state requirements, AATB Standards, and other applicable regulations.
- Direct and oversee internal audit program.
- Facilitate external audits and collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
- Serve as primary regulatory contact and maintain effective relationships with regulatory
- agencies.
- Direct and oversee supplier management program.
- Oversee regulatory review and approval for closure of deviations, nonconformance,complaints, CAPAs, SCARs.
- Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
- Oversee management of submissions of FDA/AATB reportable events.
- Direct and oversee management of state license application submissions and renewals.
- Oversee management of unique device identifiers (UDI) submissions and renewals.
- Oversee management regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, etc.
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations.
- Manage direct reports.
- Establish and monitor objective annual goals for direct reports.
- Conduct performance reviews and establish performance improvement plans as needed.
- Recruit, interview, and select personnel for hire.
Education & Experience:
- Bachelor’s degree in a biological science or related field required.
- Master’s degree preferred.
- At least 5 – 10 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management responsibilities/experience.
- Extensive knowledge of applicable government regulations.
- Ability to inform and educate department heads on regulations and policies that require compliance.
