BioTalent is partnered with a globally recognized device manufacturer seeking a QA/RA director to join their team. You'll be leading a small team as they continue to blend technology from their EU counterparts into their US product.
Responsibilities
Ensure that all products and processes comply with applicable regulatory requirements (e.g., FDA, EU MDR, ISO).
Prepare and submit regulatory documentation and applications, including product registrations, certifications, and renewals.
Ensure proper documentation of quality incidents, deviations, non-conformances, and corrective actions.
Develop and deliver quality-related training programs to employees, ensuring a thorough understanding of quality policies and procedures.
Develop, implement, and maintain the company's QMS in compliance with ISO standards and other relevant regulations.
Qualifications
7+ years experience in Quality, Manufacturing, Engineering or related field, including leadership experience.
In-depth knowledge of ISO 13485/14971, FDA 21 CFR Part 820, and other relevant regulations and standards. Including international standards (APAC, MDR, Health Canada).
Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) credentials are a plus.
Regulatory Affairs Certification (RAC) or equivalent preferred.