Principal Device Technical Regulatory Specialist

We are seeking a Principal Device Technical Regulatory Specialist to join our Global Device Development organisation. As a Subject Matter Expert in FDA, EU, and ISO standards, regulations, and guidance, you will provide expert advice to the EU regulatory function and lead project teams in regulatory strategies for combination products and medical devices.

Requirements

• Bachelor's degree in a scientific/engineering discipline
• Proven experience in pharmaceutical and/or medical device development
• Advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements
• Knowledge of global Medical Device and Drug-Device Combination Product quality requirements
• Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment
• Experience in device development programs, specifically with a focus on the preparation and delivery of technical regulatory strategy and content

Benefits

• Competitive salary
• Benefits
• Inclusive environment
• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension