BioTalent is partnered with a medical device manufacturer focusing on next-generation technology for the IVF industry. You will be focused on the production of class III devices while leading an existing team through QA/RA endeavors.

Please note that 510k submission experience is a firm requirement and will be screened for upon applying.

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
• Highly organized with excellent attention to detail