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Manager Global Regulatory Strategy Devices

This Manager Global Regulatory Strategy Devices is responsible for supporting aspects related to global registration where Bayer Radiology products are marketed. This position prepares international regulatory submissions to secure international marketing clearance as well as the preparation and maintenance of technical documentation in compliance with the European Medical Device Regulations. The position also provides regulatory support, as required, for Regulatory strategy completion/implementation, product supply projects, advertising reviews, risk management and recalls for the Radiology medical device business.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role are to:

• Support International Registration activities by compiling documents and information needed for submission to global regulatory agencies;
• Track timelines and documents milestone achievements for inclusion in regulatorysubmissions;
• Research and consolidate International regulatory requirements to enable future development of International regulatory strategies;
• Coordinate with intercompany personnel and other departments to obtain product and registration information for submission;
• Interact with distributors and other non company personnel in a professional manner to obtain requirement and solve regulatory issues;
• Track International registration status of all products and documents andupdate tracking excels and databases accordingly;
• Learn and obtain documents required for international registrations such as Certificates to Foreign Government, Certificate of Exportability and Certificates of Free Sale;
• Learn Regulatory Best Practices as well as Country Specific Regulations and Requirements;
• The incumbent should be capable of performing these tasks with moderate supervision.

WHO YOU ARE

Your success will be driven by your demonstration of our life values, more specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required qualifications:

• Bachelor's degree required. Advanced degree is a plus;
• Familiarity and hands on experience working with medical device regulations;
• Knowledge of FDA and EU medical device 510(k)/technical documentation requirements;
• Experience with medical device licensing in China;
• Working knowledge of Quality System Regulations;
• Ability to communicate and negotiate effectively in English both verbally and in writing;
• Team and customer orientation;
• Experience with multitasking in a deadline controlled and highly regulated environment.

Preferred Qualifications:

• Minimum of four years of Regulatory experience with a Bachelors degree. (2 years of regulatory experience with a Masters degree. No Regulatory experience with a PhD, P.Eng, PharmD or M.D.;
• MS Office, Regulatory info management system, (RIMs), electronic documentation systems, Adobe Acrobat.

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