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

Since its foundation in 1994, SPIGGLE & THEIS Medizintechnik GmbH (STM) has established itself as a leading provider of innovative medical devices in the field of ear, nose and throat surgery. Driven by ambition, team spirit, customer focus and international collaboration, STM has achieved sustainable global growth.

With the acquisition of Bryan Medical, LLC in July 2024, an innovative manufacturer and supplier of ENT products, particularly in airway management, STM has further expanded its international presence and gained direct access to the U.S. ENT market.

Bryan Medical, LLC is a wholly owned subsidiary of Spiggle & Theis GmbH and serves as the U.S. commercial and regulatory entity responsible for bringing Spiggle & Theis products to the American market.

Innovative and safe medical devices are the foundation of our success. To strengthen our team in Cincinnati, we are looking for a dedicated

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

Full-time, location Cincinnati (Hybrid)

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.

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 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:

• 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