Quality and Regulatory Affairs Manager (QMB)
|Job Title:||Quality and Regulatory Affairs Manager (QMB)|
|Salary:||€60000 - €70000 per annum|
|Contact Name:||Michael Burgstaller|
|Job Published:||January 22, 2021 08:56|
Cleint: A small medtech manufacturer in the field of interventional cardiology
- He/she improves procedures that maximize quality and regulatory standards; directing development and manufacturing of class IIb medical devices.
- Ensures the promotion of awareness of applicable requirements throughout the company and reports to top management.
- Provides leadership in responding to regulatory agencies (EU and worldwide) and manages international audit programs.
- Executes control over the following systems: company policy, notifiable events, CAPA, change control, documentation control, product complaint investigation and analysis.
- External interaction includes customer/supplier audits, quality and regulatory agreements, identifying product quality and regulatory trends; recommending corrective actions, initiating and directing local market approvals with partner or 3rd party agencies.
- Reviews procedures of departments by recommending solutions to problems or changes in procedures.
- Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications; establishing personal networks and benchmarking of state-of-the-art practices.
- Education in engineering, science or QM
- Significant experience in Quality Management Systems (Medical Devices)
- Experience with notified bodies, audit procedures and problem solving
- Knowledge of European regulations and standards (Medical Device Directive, Medical Device Regulation and EN ISO13485:2016)
- Preferably knowledge of MDSAP, especially related to Australia, Brazil and USA
- Ability to conduct internal audits and supplier audits
- Ability to collaborate and communicate cross-culturally and cross-functionally
- Ability to work effectively in a quickly changing, demanding environment
- Hands-on mentality with pragmatic attitude, approachable and open-minded
- Demonstrated leadership skills and willing to work in a small QM team
- Business fluent German and English (spoken and written)
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