Exciting development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.

Global Regulatory Affairs Manager II
55.00-72.75
9 Month Contract with extension or cpnversion 

• Independently provide tactical and strategic leadership on complex EU MDR projects within the Global Regulatory Affairs organization by actively compiling and authoring EU MDR-compliant STeD files.
• Independently lead development, remediation, planning, and authoring of EU MDR STeD files for Class IIa and IIb products.
• Coordinate and lead cross-functional teams aimed at remediating MDD STeD files into MDR-compliant files, including Manufacturing, R&D, Pre-Clinical Safety, and Quality.
• Lead project review meetings for management's oversight on progress and risks.

Requirements

• Experience in a medical devices required.
• Experience in MDR STeD file authoring required.
• Develop and implement regulatory strategy aligned with business strategy.
• Excellent communication and project management skills.

Preferred Skills/Qualification

• Strong technical writing skills.
• Strong project management skills.
• B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience
• MS degree and 3 years of regulatory experience.
• PhD and 1 years of regulatory experience.

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! 

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