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Regulatory Affairs Executive

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 Device Regulations, FDA Compliance

Company Overview:

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

Role Overview:

As the Director of Regulatory Affairs, you will play a crucial role in shaping our regulatory frameworks, ensuring adherence to FDA regulations, state mandates, and AATB standards. Your responsibilities will include leading both internal and external audit initiatives, acting as the main regulatory contact, managing state licensing processes, and overseeing the unique device identifiers (UDI) program. You will collaborate closely with product development and various internal departments to ensure project timelines are met and our objectives are achieved.

Key Responsibilities:

  • Oversee a team of direct reports, including setting and evaluating annual objectives, conducting performance assessments, and managing recruitment processes.
  • Formulate and execute regulatory strategies.
  • Serve as the primary liaison for regulatory bodies.
  • Administer the supplies management program and update procedures in line with FDA standards.
  • Evaluate validation and verification plans and protocols.
  • Stay informed on FDA 21 CFR 1271, FDA 21 CFR 820, and AATB regulations.

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 sector.
  • Proven leadership capabilities.
  • Familiarity with FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and other relevant regulations.

Preferred Qualifications:

  • Master's degree.