Regulatory Affairs Manager
- Location
- Cambridge, England, United Kingdom
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 and quality system changes. … Software, Bioinformatics, Clinical and Quality teams to ensure regulatory requirements are integrated into product development. Support regulatory submissions, Notified Body interactions and market access activities within the EU, UK and other international markets. Provide regulatory training and technical guidance to internal teams and support the Person Responsible for Regulatory ...