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Key position in an innovative Molecular Diagnostic Scale-Up

 Our client is a company having its 10-year anniversary and is growing rapidly. The company is offering diagnostic solutions in the areas of respiratory diseases, meningitis and sepsis. The company has developed its own technology and is headquartered in Istanbul, Turkey. In order to optimally and efficiently prepare and support the launch of new products and the market entry into new countries, the company is seeking an experienced

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

 Are you looking for a new challenge with the opportunity to proactively help an innovative scale-up company to grow and successfully enter the global market? Then give us a call or send us your application documents, quoting reference number GWB 9446. Priska Kramer and Bernd Maisenhölder look forward to getting to know you.

Stettler Consulting AG

Executive Services Health Care

Burgstrasse 29

8706 Meilen

Tel. 043 288 43 43 Ref. Nr. GWB 9446

www.stettlerconsulting.ch

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