Key skills
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About this role
Role Overview
- Implement regulatory strategies and manage regulatory submissions
- Assess regulatory impact of product changes
- Provide guidance and mentorship to team members
- Collaborate with cross-functional partners including R&D, clinical, operations, and marketing
- Represent the company in discussions with regulatory bodies and industry groups
- Support regulatory compliance and business objectives for Acute Care & Monitoring
Requirements
- Level 8 Honor’s Degree Science or Engineering bachelor’s degree/master's
- Minimum of 5 years of relevant experience, preferably with Class I & Class II Medical Devices
- A Regulatory Affairs qualification is desirable, but not mandatory
- Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required
- Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745
- Experience with software and hardware medical devices
Benefits
- Competitive Salary
- Flexible Benefits Package