Regulatory Affairs Manager (all genders)

LARALAB; München; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A growing international company in the medical software field seeks a Regulatory Affairs Manager to oversee regulatory submissions and compliance for AI products. The role requires expertise in the certification process and knowledge of relevant medical device regulations. The position offers flexible working hours, an office in central Munich, and a chance to make a positive impact on healthcare innovation.

Leistungen

Flexible working hours

Remote working possibilities

Company sports program

Free snacks and drinks

Qualifikationen

• Initial professional experience in Regulatory Affairs and medical device certification.
• Experience with CE and FDA regulatory submissions.
• Knowledge of applicable laws and regulations for medical software.

Aufgaben

• Drive regulatory clearance for new AI products focused on CE and FDA.
• Contribute to technical documentation, clinical evaluation, and risk management.
• Support the improvement of the Quality Management System.

Kenntnisse

Attention to details

Problem-solving

Team-working

Self-motivation

Ausbildung

Degree in life science, engineering, informatics, or medicine

Tools

Adobe Acrobat

Jobbeschreibung

Would you like to play a central role in this growth process Were looking for a Regulatory Affairs Manager to join our team of medical and software experts. In this role youll play a key part in bringing new AI products to global markets - driving regulatory submissions and strategy building technical documentation and helping evolve our quality processes to support rapid innovation. Join us to actively shape the next generation of medical software.

• Drive regulatory clearance for new AI products and modules focussed on CE and FDA
• Stay ahead of the fast-paced evolution of regulatory requirements and AI capabilities to ensure the compliance of our medical device software
• Contribute to key regulatory areas such as technical documentation clinical evaluation risk management and performance evaluation
• Support the continuous improvement and efficient operation of our Quality Management System

Your Skills

• Degree in life science engineering (medical) informatics medicine or similar
• Initial professional experience in Regulatory Affairs and certification of medical device software
• Experience with regulatory submissions and approval processes (esp. CE and FDA)
• Knowledge of laws standards and regulations applicable to medical device software (e.g. MDR 2017 / 745; 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971)
• Initial professional experience in Quality Management is a plus
• Attention to details and problem-solving mindset
• High level of self-motivation team-working attitude ability to adapt in a fast-paced environment

Be Part of Our Story there is a lot in it for you!

• Using your Regulatory Affairs expertise to make a positive impact on peoples lives
• The chance to be part of a growing international company and a passionate highly skilled team
• Flexible working hours and remote working possibilities
• Company sports program (Wellpass JobRad) and free snacks and drinks
• An office conveniently located in the heart of Munich

Application and Contact

Sounds interesting Wed love to hear from you! Send us your CV a brief motivation letter and any relevant certificates. Have questions Well be happy to answer them! -

About us

LARALABs goal is to revolutionize the planning of cardiac interventions and improve the lives of patients worldwide. We are developing cloud-based planning software powered by deep learning technology to support the innovation of new minimally invasive cardiac procedures and to make these procedures available to patients in need. We have collaborations with leading clinics and medical companies and are backed by strong investors.

Required Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1