Quality and Regulatory Affairs Manager
vor 1 Woche
Quality and Regulatory Affairs Manager (m/f/d) – Medical Devices
Location: Hamburg or remote
Who we areLITERO 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
- 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: -
DatenArt der Beschäftigung:
Stellenangebot
Befristung:
Unbefristet
Bereich:
Medizintechnik
Einsatzort:
Hamburg, Hamburg or Remote
Beginn:
Wochenstunden:
Teil- oder Vollzeit
KontaktUnternehmen:
LITERO GmbH
Ansprechpartner:
Dr Kristijana Milovic-Holm
E-Mail:
k.milovic--
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