Regulatory Affairs Manager
- Location
- Cambridge, England, United Kingdom
development and implementation of regulatory strategies for new product development, product changes and lifecycle management. Prepare and maintain regulatory documentation including Technical Files, Risk Management Files, Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Biological Evaluation Reports (BERs) and associated technical documentation. Provide regulatory input throughout the product … development lifecycle, ensuring compliance with design control, verification, validation and change management processes. Lead regulatory activities relating to analytical performance, clinical performance, scientific validity and software validation. Support Post-Market Surveillance (PMS), vigilance, trend reporting and regulatory compliance activities. Conduct regulatory impact assessments and provide guidance on product, manufacturing ...