Regulatory Labelling Manager (m/f) in Baar

Our clients is an internationally leading Medical Technology Company who offers an exciting tailored career path for your professional and personal development within their Regulatory Affairs & Quality Assurance team. The client is specialized on heart diagnosis, monitoring as well as software solutions. The manufacturing takes place in Switzerland and the products are distributed worldwide.

Tasks:

• Coordinating global regulatory affairs functional activities to ensure effective support to achieve existing plans and objectives
• Manage and be responsible for regulatory label compliance e.g. UDI requirements
• Manage international regulatory submission process through to approval, including management and coordination of preparation of all regulatory documentation
• Close cooperation with local regulatory representative e.g. in Asia Pacific region and Latin America for product registration
• Support distributors world-wide for product registration
• Involved into change assessment process
• Be a part of review process for labelling and marketing documents
• Support regulatory training
• Keep up-to-date with the current regulatory environment (medical device)

Requirments:

• Fluent in English, German is a plus
• Experienced in international medical device environment and familiar with active medical devices
• In-depth know-how of regulatory labelling including UDI
• Experienced with CE-marking and international registration process. FDA 510(k) and PMA submission, experience is a plus
• Good organizational and planning skills
• Good communication skill with local regulatory representatives and distributors

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: p.ognjenovic@sciproglobal.de

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