Bayer posted a job you might be interested in January 23, 2015 at 04:23PM

Bayer



Regional Regulatory Affairs Manager Europe & EMEA - IVD/Medical devices (m/f) 7-9 months

Basel Area, Switzerland, CH - Pharmaceuticals

• Develop and implement regulatory strategies that provide leadership to the Global Product Development Teams (Core and Element Teams) in the development of new products and ensure continued regulatory compliance for current products in a complex and changing regulatory environment in Europe and EMEA.


• Expert on European and International standards (ISO, EN, ASTM) concerning the development and product placement of medical devices and IVDs.


• Develop, review and approve Technical Documentation which is necessary to gain regulatory approval for the EU / EMEA region. Maintain the regulatory status by monitoring European and national regulations, e.g. applicable national laws and guidelines and European and International standards.


• Submit Technical Dossiers to Regulatory Bodies and Authorities to ensure the obtaining of all necessary regulatory approvals. Follow up communication with Regulatory Bodies and Authorities to resolve any questions and concerns.


• Global Bayer Diabetes Care representative in European industry associations to represent Bayer’s position and influence the policies of the regulatory authorities.


• Lead Global Packaging & Design as expert in development of product labeling that complies with European and other regional requirements.


• Member of Global Legal, Medical and Regulatory reviews to ensure that European market and regulatory requirements are met.


• Regulatory expert for DC Quality Management / Complaint Management personnel concerning resolution of quality issues for EU/EMEA (Stop Shipment, Repackaging Relabeling Rework Activities)

No salary provided



Posted January 23, 2015 at 04:23PM from LinkedIn http://ift.tt/1JhuumV

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