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

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

Job Title: Head of Quality and Regulatory Affairs 100% (m/f) in Basel
Contract Type: Permanent
Location: Basel,
Salary: Swiss Franc124000 - Swiss Franc144000 per annum
Start Date: ASAP
Reference: SPPO0901
Contact Name: Petra Ognjenovic
Contact Email:
Job Published: January 09, 2017 12:39

Job Description

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.


  • 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


  • 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:

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