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Head of Regulatory Compliance

2 months ago

Texas, United States Talently Recruiting Full time

Position Title: Director of Regulatory Affairs

Location: San Antonio, TX

Compensation: $140K - $160K+ based on experience, plus a performance bonus of 25%

Required Expertise: Regulatory Affairs, Leadership, Medical Devices, FDA Compliance

Company Overview:

We are a pioneering organization in the medical devices sector, specializing in regenerative medicine. We are seeking a skilled Director of Regulatory Affairs to spearhead our regulatory initiatives and foster innovation within our expanding team.

As the Director of Regulatory Affairs, you will play a crucial role in shaping our regulatory framework, ensuring adherence to FDA regulations, state mandates, and AATB standards. You will oversee internal and external audit processes, act as the main regulatory contact, manage state licensing applications and renewals, and supervise the unique device identifiers (UDI) program. Working in close collaboration with product development and other departments, you will help us achieve project milestones and advance our objectives.

Core Responsibilities:

  • Supervise direct reports, including setting and tracking annual objectives, conducting performance evaluations, developing performance enhancement plans, and participating in the recruitment process.
  • Formulate and execute regulatory strategies.
  • Serve as the primary liaison for regulatory bodies.
  • Oversee the supplies management program and update procedures in line with FDA regulations.
  • Evaluate validation and verification plans and protocols.
  • Stay informed about FDA 21 CFR 1271, FDA 21 CFR 820, and AATB standards.

Essential Qualifications:

  • Bachelor's degree in biology, biomedical sciences, or a related discipline.
  • A minimum of 5 years of regulatory experience within an FDA-regulated setting.
  • Experience in the medical devices field.
  • Proven leadership capabilities.
  • Familiarity with FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and other relevant regulations.

Preferred Qualifications:

  • Master's degree.