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Regulatory Affairs Leader - AI Software Devices (f/m/d)

Remote, Germany R

EUR 63K-90K (estimate) Senior-level Full Time

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Found 2d ago

Tasks

Apply regulatory requirements to submissions
Assess product changes impact
Determine new or revised licenses registrations
Develop regulatory strategy
Ensure postmarket compliance
Ensure premarket submissions compliance
Manage notified body audits
Optimize regulatory submission pathways
Plan registration submissions
Provide regulatory leadership
Research and analyze regulatory background information
Review advertising and promotion materials
Support quality system audits
Write and edit technical documents

Perks/Benefits

N/A

Skills/Tech-stack

Advertising review | Clinical data | Medical Device | Medical device regulations | Postmarket Compliance | Premarket Compliance | Project Management | Quality System | Regulatory Submissions | Regulatory strategy | Risk Assessment | Technical documentation

Education

Bachelor of Engineering | Bachelor of Science | Bachelor of Science in Software Engineering

Roles

Manager | Regulatory Affairs Manager | Regulatory Affairs Specialist | Specialist

Regions

Countries

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