Regulatory Affairs Manager Medizintechnik (m/w/d)
Core
Managing product approvals and regulatory compliance for medical devices in the EU and international markets.
Role type
Regulatory Affairs Manager (via careerplan.io/jobs/2739184-regulatory-affairs-manager-medizintechnik-mwd-at-pmx-gmbh)
Builds
Regulatory submissions and compliance documentation for medical device products
Domain
Medical Devices / Regulatory Affairs
Required skills
Product regulatory strategy, Post-market surveillance, Risk management, Technical documentation, Project management, Standards interpretation
Preferred skills
Knowledge of MDR (EU) 2017/745, ISO 14971, IEC 60601-1, IEC 62304, ISO 10993
Technologies
MDR (EU) 2017/745, ISO 14971, IEC 60601-1, IEC 62304, ISO 10993
Responsibilities
Steer product approvals and regulatory requirements, Monitor product changes and post-market surveillance activities, Evaluate relevant standards and regulatory provisions, Define product requirements for new developments, Assess regulatory changes and implement necessary measures, Coordinate risk management processes in development projects, Organize and accompany external audits, Create and maintain technical documentation according to standard requirements
Seniority
Mid-Senior, hands-on IC