Quality & Regulatory Affairs Manager; m​/f​/d

To strengthen our team in Cincinnati
, we are looking for a dedicated

Quality & Regulatory Affairs Manager (m/f/d)

In this role, you will independently manage all quality and regulatory activities for existing products as well as new product introductions in the U.S. market. This is a hands‑on individual contributor role without direct reports, reporting directly to the President of Bryan Medical.

• Prepare and submit FDA 510(k) applications and lead Pre‑Submission meetings
• Serve as the primary point of contact for direct communication with the FDA
• Manage regulatory inquiries and maintain technical and submission documentation
• Support EU MDR activities in collaboration with the team in Germany
• Own ISO 18562‑related activities (test strategy, documentation, traceability)
• Maintain and continuously improve the Quality Management System (ISO 13485 / FDA), including SOPs, CAPA, audits, and complaint handling
• Implement and manage an electronic QMS (eQMS)
• Drive quality activities in manufacturing (e.g., NCRs, root cause analysis, corrective actions)
• Manage supplier quality, including qualification, monitoring, and SCARs
• Ensure timely handling of complaints and RMAs
• Plan and conduct internal and external audits and report quality metrics
• Support international product registrations, particularly in LATAM markets

• Bachelor’s degree in a relevant field or equivalent professional experience
• Proven experience in preparing and submitting FDA 510(k) applications as well as direct interaction with the FDA
• Strong knowledge of ISO 13485 and key quality system processes, including CAPA, audits, and document control
• Hands‑on experience in medical device manufacturing quality
• Experience with the implementation or management of eQMS systems
• Familiarity with EU MDR requirements
• Experience with ISO 18562 is desirable
• Experience with LATAM registrations (e.g., COFEPRIS, ANVISA) is an advantage
• Relevant certifications such as RAC, ASQ CQE, or CQM are a plus
• Independent, structured, and reliable working style with a high level of ownership
• Strong communication skills and the ability to collaborate effectively across teams, organizations, and cultures

• A key role with a high level of responsibility and autonomy
• Direct collaboration with executive leadership
• An international work environment with teams in the U.S. and Germany
• Short decision‑making processes and room for initiative
• Exciting opportunities in a growing medical device company