Beschreibung
One of the largest healthcare organisations in the world is currently in need of a Medical Device Quality Risk Manager to step in for a fixed term temporary assignment in the greater Munich area, Germany. This is a fantastic opportunity for a seasoned Medical Device/Combination Products professional to impact the technical development and quality practices in a highly innovative environment.The Role:
- Responsible for Medical Device Risk Management
- Utilize proactive risk management tools and approaches to minimize impact on global supplies and patients
- Ensure risk management processes for medical devices according to ISO 14971 and IEC 62366
- Evaluation of risk associated to non-conforming products
- Evaluation of risk values for specific Medical Device defects
- Periodic risk management reporting for all MDs
- Product assessments, medical device reporting and recall activities per global standards and policies
- - Responsible for all quality related risk evaluation processes starting from development (hazard analysis) until life cycle management (incident risk analysis)
Your Profile:
- At least 3 years of relevant experience
- Fluent English in both written and spoken form
- Degree in Chemistry, Pharmacy, Microbiology, Biotechnology, or related sciences
- Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations
- Good knowledge of medical device development and lifecycle management
- Strong regulatory, technical, and scientific knowledge in a specific area
Desirable Skills:
- French and German Skills
Should you match the above requirements, please submit and updated version of your CV and we will be in contact shortly.
Key Words: GMP, GxP, ISO 14971, IEC 62366, Medical Device, Med Dev, Combination Products, cGMP, Risk Management, Product Assessments, Risk Evaluation, Hazard Analysis, Quality, SOP, Regulatory, Regulatory cGMP, ISO 13485, English, French, German
Mehr Informationen über Real Staffing erhalten Sie unter www.realstaffing.com/de