Regulatory Affairs Specialist

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.

Regulatory Affairs Specialist/Evaluations

• Evaluate, author, revise and update Regulatory Documentation for clinical evaluations for Medical Device Regulation (MDR) remediation and Post Production Risk Reviews (PPRRs).
• Write and review clinical evaluation reports (CERs), literature reviews, and clinical risk assessments.
• Conduct systematic literature reviews and regulatory risk analysis
• Provide clinical functional review while ensuring compliance with global regulatory requirements.

Required Qualifications:

• Master’s or Ph.D. in Vision Science, Biomedical Engineering, Life Sciences, or related field.
• Strong background in in European Medical Device Regulations (MDR), particularly in clinical evaluations and post-market surveillance.
• Experience in writing and reviewing clinical evaluation reports and clinical risk assessments.
• Proficient in Microsoft Office Suite and regulatory documentation software.
• Strong communication and writing skills.

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!