Head Quality Management

vor 2 Wochen

Schweiz Stettler Consulting Vollzeit

**You can look forward to this**:

- Opportunity to help shape a dynamic biotech company and drive its growth
- You play a key role in positioning the company in the global market
- Dynamic and very interesting environment in the field of molecular diagnostics

**Your tasks and responsibilities**:

- **Liaise with regulatory authorities**: Establish and maintain relationships with regulatory authorities and act as the primary point of contact between the organization and notified bodies.
- **Regulatory Strategy**: Develop and implement regulatory strategies to navigate the regulatory landscape effectively. This involves anticipating regulatory changes, assessing their impact on the organization, and devising proactive compliance strategies.
- **Quality Assurance and Control**: Ensure that products and processes comply with regulatory requirements. Implement and maintain quality management systems to meet regulatory standards.
- **Quality Management System oversight**: Establish, implement and maintain the QMS in accordance with the standards ISO 13485 and ISO 9001
- **Customer Audits and Visits**: Coordinate and facilitate customer audits or visits related to quality. Provide necessary documentation and information to demonstrate the organization’s commitment to quality
- **Leadership**: manage remotely a team of 5 employees based in Turkey

***Your profile**:

- You have a strong background in regulatory affairs and ideally also quality management in the field of in-vitro diagnostics
- You have sound knowledge about the new IVD-R guideline; in addition, you have experience with ISO 13485 and ISO 9001
- You are a strong communicator, willing to travel and resilient
- You are fully proficient in German and English

**Stettler Consulting AG**
**Executive Services Health Care**
Burgstrasse 29
CH-8706 Meilen
Tel. +41 (0)43 288 43 43; Ref. Nr. **GWB 9446

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