Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.

The Senior RA Cybersecurity & AI Manager (m/f/d) will drive global regulatory strategies and compliance activities for In Vitro Diagnostic (IVD) and medical devices (MD) products with a focus on cybersecurity and artificial intelligence (AI). This role will ensure that the organization’s IVD and MD products meet regulatory requirements and standards in Europe, the United States, and other international markets. The position requires deep expertise in cybersecurity, AI/ML (Artificial Intelligence/Machine Learning), and regulatory frameworks such as the EU IVDR/MDR, FDA requirements, and other applicable global standards.

Tasks

Cybersecurity Compliance

Develop and implement cybersecurity strategies.
Maintain cybersecurity documentation.
Collaborate with teams to mitigate risks.
Handle regulatory submissions and audits.

AI/ML Regulatory Compliance

Develop strategies for AI/ML-enabled products.
Guide regulatory submissions for AI-based products.
Ensure compliance with global standards.
Monitor regulatory landscape for AI in healthcare.

Regulatory Strategy and Submissions

Lead preparation and submission of regulatory dossiers.
Develop market access strategies.
Liaise with regulatory bodies.

Post-Market Surveillance

Implement post-market cybersecurity and AI monitoring.
Respond to incidents and breaches.
Develop monitoring plans for AI/ML systems.

Leadership and Collaboration

Provide thought leadership on regulatory compliance.
Train and support internal teams.
Stay updated on trends and guidelines.

Requirements

Bachelor’s degree in a relevant technical field.
Certifications in regulatory affairs or cybersecurity are desirable.
7–10 years of experience in regulatory affairs for medical devices or IVDs.
Proven track record in regulatory submissions for cybersecurity and AI-enabled devices.
Strong analytical, project management, and communication skills.

Benefits

Flexible working hours, incl. mobile work
30 days of holiday time each year
13,5 salaries a year
Regular training courses
Extensive company pension scheme
Payments towards an employee savings plan
Preventive healthcare, free beverages & fresh fruit and vegetables daily
Joint company events and activities
Interesting, diversified field of activity in an international working environment

Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.

Jobs at EVIDENT Europe GmbH

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