Global Regulatory Affairs – Associate Director – UK Regulations Focus

Global Regulatory Affairs – Associate Director – UK Regulations Focus

Requirements

• BS/BA with 12+ years OR a Master’s with 10+ years OR a PhD + 8+ years of experience or equivalent
• Experience of working in IVD, medical device, or pharma industries in regulatory affairs/quality roles with experience of regulatory submissions and safety
• Experience with regulatory support and submissions in the UK and EU
• Demonstrated knowledge of regulations and procedures required for the development of new medical devices, submission of applications to International health authorities and FDA for approval to market new medical devices
• Excellent oral and written communication skills
• Strong organizational skills and attention to detail required

Responsibilities

• Be responsible for ensuring electronic registration of GRAIL IVD medical devices compliant with the applicable Regulations and Annexes in the Database of the MHRA and similar processes in other assigned jurisdictions as required
• Represent GRAIL during communications and meetings with MHRA and interfaces with regulatory authorities on regulatory and technical matters, as appropriate
• Ensures that UK specific declaration of conformity and technical documentation created by the manufacturer are available and, as needed, can be provided to MHRA
• Be responsible for reporting safety events to the MORE database if needed and/or submitting reports in other assigned jurisdictions as required
• Support the legal manufacturer (GRAIL US) in preparation and delivery of required regulatory reports, e.g. annual reports to the MHRA according to regulatory reporting timelines for marketed products in assigned jurisdictions
• Supporting/planning/contributing to processes for safety data collection of marketed products in the UK including oversight of processes for data collection from external vendors/distributors/other sources as applicable
• If required, responsible for managing indirect and direct reports
• Performs other duties as required or assigned

Preferred Qualifications

• Experience in diagnostics or biomarker development with emphasis on oncology is a plus
• Advanced scientific degree a plus
• Regulatory Affairs Certification preferred
• Track record of leadership, providing sound judgment/ideas and business partnering
• Demonstrated ability to effectively present information to senior management and to regulatory agencies (including MHRA, EU Notified Bodies)
• Strong interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations