Quality and Regulatory Affairs Manager

Company Description

Bryan Medical, the market leader in innovative airway and ENT solutions, including the Aeris™ Balloon Dilation System, Tenax™ Laser-Resistant Endotracheal Tube, and  Infinity™ Esophageal Dilation System. Our products are designed in collaboration with leading physicians to improve patient safety, clinical efficiency, and surgical outcomes. In 2024, Bryan Medical was acquired by Spiggle & Theis Medizintechnik GmbH (STM) and serves as the U.S. commercial and regulatory entity responsible for bringing Spiggle & Theis products to the American market. With its critical products, Bryan Medical empowers physicians to make significant, positive impacts on patient outcomes.

Role Description

This is a full-time, hybrid role for a Quality and Regulatory Affairs Manager. The role involves managing compliance with regulatory standards, establishing and maintaining quality control processes, and ensuring adherence to quality assurance and management systems. The manager will collaborate with internal teams and regulatory agencies to ensure product certification and operational excellence in all regulatory and quality initiatives. This is a hands-on individual contributor role without direct reports, reporting directly to the President of Bryan Medical.

Duties & Responsibilities:

• 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

The ideal candidate will have:

• Bachelor’s degree (minimum) 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

We offer:

• Generous compensation package
• Company-provided health and dental benefits
• Paid time off and company-paid holidays
• 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