Senior Consultant Regulatory Affairs MedTech

Vor 4 Tagen

Munich, Deutschland ARCONDIS Vollzeit

Tasks and responsibilities

We are looking for an experienced Regulatory Affairs professional to join our dynamic international consulting team and play a key role on a project for one of our key clients.

Consult our clients in development and implementation of regulatory strategies, identifying the most efficient and compliant regulatory pathways to bring clients’ products to the market

Advise our clients on the regulatory data (e.g. EUDAMED) and information necessary to support dossier submission mainly to EU and US health authorities

Perform gap analysis on existing dossiers for regulatory approvals or clearance

Support clients in the liaison with health authorities, facilitating effective communication and swift resolution of issues

Consult and support our clients in implementation of additional components beyond the standard ISO 13485, that are required for a Quality Management System (QMS) that incorporates Artificial Intelligence (AI), e.g. focus on data management, AI-specific risk management, ethical considerations

In close collaboration with our clients support from regulatory perspective implementation and maintenance of clients’ Quality Management Systems acc. to ISO 13485

Keep abreast of changes in global regulatory guidelines, standards, and policies, interpreting their implications for client projects

Provide training to clients' internal teams on global regulations, guidelines, and processes

Be a driver of our business development and regulatory affairs services

Studies

Your profile

Bachelor's or Master's degree in Life Sciences, Regulatory Affairs or correlated field

Minimum of 10 years' experience in Regulatory Affairs within the MedTech industries

In-depth knowledge and understanding of EU and US MedTech regulations and submission processes

Experience in communication and exchange with Health Authorities for SaMD, AI, Robotics submissions, like FDA, EMA

Demonstrated success in preparing and managing EU and US submissions and approvals, incl. 510k

High degree of quality awareness

Strong attention to detail, self-contained, and responsible way of working

Good understanding of Good Manufacturing Practices (GMP)

Proficiency in project management and ability to handle multiple projects simultaneously

Excellent English written, and verbal communication skills, German and other languages are a plus

Ability to work in international and interdisciplinary teams

Willingness to continuously improve and to grow with new challenges

Willingness to travel, including overseas

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