Global Regulatory Affairs Manager II - Fort Worth, United States - Randstad Life Sciences US

Description

Immediate opportunity for a Global Regulatory Affairs Manager II to work with a leading, global medical device company focused on vision research and eye health. This position will 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.

Position Type: Contract position for 9 mos.

Location: Remote

Essential Duties and Responsibilities:

• 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.

Qualifications:

• PhD and 1 years of regulatory experience in the medical devices field.
• MS degree and 3 years of regulatory experience in the medical device field.
• B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience in the medical device field.
• Experience in MDR STeD file authoring required.
• Develop and implement regulatory strategy aligned with business strategy.
• Excellent communication and project management skills.
• Strong technical writing skills.