Are you an expert in Regulatory strategies with a passion for medical devices? We are seeking a Senior Regulatory Affairs Specialist to lead and develop regulatory strategies across the EMEA region and globally. The role is Hybrid and will working in the Berkshire / Bucks area.
Key Responsibilities:
- Coordinate Regulatory Deliverables: Manage regulatory deliverables for medical devices to ensure compliance and timely approvals.
- Develop Partnerships: Collaborate with R&D, Marketing, and local regulatory teams to align on regulatory strategies and objectives.
- Prepare and Maintain Technical Files: Compile and update technical files and submission packages to meet regulatory requirements.
- Represent Regulatory Affairs: Act as the Regulatory Affairs representative within the franchise, providing insights and guidance on regulatory matters.
Requirements:
- Educational Background: Relevant Bachelor's Degree or higher in a related field.
- Medical Device Expertise: In-depth knowledge and experience with Class I-III Medical Devices.
- Regulatory Knowledge: Strong understanding of Medical Device Directive (MDD), Medical Device Regulation (MDR), and ISO 13485 standards.
- OTC or Consumer Health experience would be an added bonus.
- Language Proficiency: Fluency in English, both written and spoken.
- Experience with Notified Bodies: Proven experience working with Notified Bodies and understanding of regulatory frameworks.
Why Join Us?
- Critical Role in Product Lifecycle Management: Play a pivotal role in managing the lifecycle of our products, from development to market.
- Influence Regulatory Strategies: Have a significant impact on the development and execution of regulatory strategies and outcomes.
- Collaborative Environment: Work with a dynamic, cross-functional team dedicated to innovation and excellence in regulatory affairs.
Apply now to be part of an innovative team driving regulatory excellence and compliance
