Director International Regulatory Affairs And Compliance

Firmenprofil

Our client is a global specialized in vitro diagnostics company. By order of our client we are looking for a Director International Regulatory Affairs and Compliance (m/f).

Position

• Sets direction and monitors progress to achieve added value from the company's Regulatory Affairs and Compliance, including Quality Assurance, Quality Control, Complaint Management, Technical Training and Product Investigation activities
• Manage all international regulatory and quality functions
• Direct the implementation of quality system improvements and commitments to regulatory agencies
• Maintain, refine and implement (process oriented) quality system manual and procedures
• Keeping and improving the global awareness regarding QMS
• Work with global Regulatory Affairs / Compliance to focus on universal solutions for key QMS issues
• Managing processes regarding investigation and resolution of 'third level' complaints
• Provide structures, techniques, infrastructure and expertise to perform product investigations
• Managing the originating and disseminating technical communications, including Technical Advice Notes, Service Manuals etc.
• Act as primary liaison between the company and regulatory agencies in Germany and EU
• Support contact to regulatory agencies in other countries managed by affiliates or distributors
• Evaluate changes to all products for regulatory impact and reporting requirements to notified body and foreign regulatory agencies
• Identify both domestic and international strategic product approval and registration to support free market access of company products
• Provide regulatory oversight of product development processes and support regarding regulatory approvals on international leve
• Authorized to initiate product field actions and to notify appropriate regulatory agencies, affiliates and distributors

Profil

• Scientific background (university degree e.g, medicine, pharmacy, biology, preferably MD) with a relevant scientific and clinical experience in transfusion in vitro diagnostics preferably holder of a doctorate
• A minimum of 3 - 5 years experience working in a clinical or pharmaceutical environment as a responsible Manager in Regulatory Affairs and Quality Management
• Experience in and understanding of regulatory standards as applied to corporate quality system
• Understand source, composition and characteristics of products and associated chemical and bio-safety hazards
• Excellent Communication and presentation skills
• Flexibility and ability to adjust immediately to changing circumstances
• Thinking in terms of solutions
• Hands-on mentality
• Self-starter with a high degree of independence
• Fluent in spoken and written English and German; knowledge of other languages would be desirable

Interessiert?

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