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

Quality and Regulatory Affairs Manager (m/f/d) – Medical Devices
Location: Hamburg or remote

Who we are

LITERO GmbH is a specialized consulting company supporting medical device manufacturers in meeting global quality and regulatory requirements. Our team provides expert guidance in quality management, regulatory compliance, and clinical affairs according to ISO 13485, IEC 62304, MDR, FDA, and other international standards. From developing and maintaining Quality Management Systems to preparing technical documentation and navigating global registrations, we help our clients bring safe, compliant, and innovative products to market.

Your responsibilities

Preparation and maintenance of quality management documentation according to ISO 13485 and related standards
Preparation of regulatory documentation and support of submissions in line with MDR, FDA, and other international regulations
Conducting regulatory gap analyses and supporting the integration of global requirements into client QMS
Advising clients on product classification, conformity assessment, and international market access

Your profile

University degree in life sciences, engineering, medical technology, or a related field
At least 2 years of professional experience in Quality and/or Regulatory Affairs for medical or pharmaceutical products
Solid understanding of MDR, ISO 13485, ISO 14971, IEC 62304, and risk management processes
Independent, structured, and proactive working style
Fluent in English (German proficiency is a plus) What we offer
Flexible and remote working options
A small, supportive, and dynamic team
Opportunities for professional growth and specialization
Regular training programs
30 days of annual leave

If you are passionate about regulatory excellence and want to contribute to advancing safe and compliant medical devices, we look forward to receiving your application!
Apply by sending your CV: info@litero-agency.com