Global Regulatory Affairs Manager II

Regulatory Affairs

Houston, TX, US

Pay Rate Low: 65.00 | Pay Rate High: 75.72

• Added - 08/03/2024

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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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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.