Regulatory Affairs Specialist

About This Role

This role involves ensuring regulatory compliance for innovative healthcare products by supporting regulatory planning and strategy, advising product design teams, and facilitating regulatory submissions to bring products to market successfully.

Responsibilities

• Assist with the implementation of global regulatory roadmaps and marketing strategies
• Advise product design teams on regulatory strategy for new products
• Plan regulatory compliance for new product introductions and changes
• Support development of regulatory plans and risk assessments for product registrations
• Facilitate regulatory submissions and identify potential approval risks

Requirements

• Bachelor's or Master’s degree in relevant fields (Chemistry, Biomedical Engineering, or Law)
• 2+ years of experience in regulatory affairs or compliance for medical devices
• Understanding of cosmetic formulation chemistry and global regulations
• Strong analytical, project management, and stakeholder communication skills

Qualifications

• Bachelor's or Master’s degree in relevant fields such as Chemistry, Biomedical Engineering, or Law
• 2+ years of experience in regulatory affairs or compliance for medical devices

Benefits

Certifications