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

USA

Vollzeit

Festanstellung

Ihre Aufgaben

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

Ihr Profil

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

Warum wir?

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

Über uns

Seit der Firmengründung 1994 haben wir uns als führender Anbieter von innovativen Medizinprodukten in der Hals-Nasen-Ohren-Chirurgie etabliert. Ambition, Teamgeist, Kundenorientierung und Internationalität stellen seither ein nachhaltiges und globales Wachstum sicher. Mit der Akquisition der Bryan Medical LLC in den USA im Juli 2024, einem innovativen Hersteller und Anbieter von HNO-Produkten, speziell im Bereich des Atemwegsmanagements - verfügen wir nun über einen direkten Zugang zum US-HNO-Markt und einem noch breiteren Sortiment.