Head of Quality and Regulatory Affairs 100% (m/f) in Basel

Our client is a start-up in vitro diagnostics company developing qualitative diagnostic tests for the detection and screening of various infectious diseases.

Therefor we are looking for a constructive and solution-oriented personality as Head of Quality and Regulatory Affairs. Our client offer an attractive working environment combined with a supportive and understanding team for Quality.

The jobholder will report directly to the CEO/CFO.

Responsibilities:

• Maintenance and performance monitoring of the Quality Management System
  according to EN ISO 13485
• Responsible for risk management according to EN ISO 14971
• Quality planning (verification and validation)
• Addressing quality issues and implementing quality controls
  to ensure continuous compliance
• Execution of audits (supplier audits)
• Initiation and monitoring of actions
• Organisation of Management Reviews and monitoring of resulting actions
• Process validation, QA and QC monitoring and product release
• Assuring communication with internal and external stakeholders
• Establishment of productive relationships with statutory and regulatory authorities

Qualifications:

• University Degree in Molecular Biology or similar education, preferably with Ph.D.
• Further education in Quality System Management
• At least 3 years of experience in Quality Management in IVD or Medical Device industry
• Additional experience in IVD product development and launch is strongly preferred
• In depth knowledge of EN ISO 13485 requirements and relevant international standards, regulations and directives
• Hands on experience in quality assurance
• Regulatory, legal and QC support and working closely with other stakeholders on different level
• A team player with assertiveness and strong communication skills who shows flexibility especially within a start-up company
• strong Analytical thinking
• strictly goal oriented as well as self-motivated
• High accuracy in management of data
• Fluent in English and German, spoken and in writing
• Willingness to travel worldwide

Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to Petra Ognjenovic: p.ognjenovic@sciproglobal.de

In case of any further question, please do not hesitate to contact
Petra Ognjenovic: 0049 89 2109 4906.