An in vitro diagnostics product development company with a unique

technology platform

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Job profile: Date: January 5 , 2017

We are looking for a

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

Description:

Hutman Diagnostics AG is a start-up in vitro diagnostics company developing qualitative diagnostic tests for
the detection and screening of multiple pathogens and antibiotic resistance markers of various infectious
diseases.

We are looking for a constructive and solution-oriented personality as Head of Quality and Regulatory Affairs.
This position (100%) will be for an unlimited period of time, starting as soon as possible. Location: Basel,
Switzerland

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 timely and objective internal and external audits (supplier audits)
- Initiation and monitoring of corrective and preventive actions
- Organisation of yearly 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:

Education and experience

- 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 levels

Soft Skills
- A team player with assertiveness and strong communication skills who shows flexibility especially
within a start-up company
- Analytical thinking
- Goal oriented, self-motivated
- High accuracy in data management
- Well organized, plans with foresight
- Fluent in English and German, spoken and in writing
- Standard IT literacy
- Willingness to travel worldwide

We offer:
- Attractive working environment
- Supportive and understanding team for Quality
- Compensation commensurate for the position

Office/Laboratory: Technologiepark Basel, Hochbergerstrasse 60C, CH-4057 Basel, Switzerland,

(+41 (0) 61 319 7000 (main line) - CHE-110.171.891 MWST
www.hutmandiagnostics.com @ hutman@hutmandiagnostics.com