Senior Regulatory Affairs Cybersecurity AI Manager mfd - Clinical Business
Senior Regulatory Affairs Cybersecurity AI Manager mfd - Clinical Business
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Job Description
Headquartered in Tokyo Japan Evident employs around 4500 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 nondestructive testing techniques and for Xray 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 organizations 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/MLenabled products.
- Guide regulatory submissions for AIbased 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.
PostMarket Surveillance
- Implement postmarket 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
- Bachelors degree in a relevant technical field.
- Certifications in regulatory affairs or cybersecurity are desirable.
- 710 years of experience in regulatory affairs for medical devices or IVDs.
- Proven track record in regulatory submissions for cybersecurity and AIenabled devices.
- Strong analytical project management and communication skills.
Benefits
- Flexible working hours incl. mobile work
- 30 days of holiday time each year
- 135 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.
Employment Type
Full Time
