Regulatory Affairs Manager

Regulatory Affairs Manager Required by a Highly Successful, Rapidly Expanding Company, where the Successful Applicant will be a Key Member of the Leadership Team and will be Actively Involved with the QA/RA Director, Commercial and R&D Teams to Generate Regulatory Plans and Strategies for Medical Products and Services

ROLE

• Develop, Compile and Review the Technical Documentation Required for Regulatory Submissions: USA, EU, Middle East and North Africa (MENA), Gulf Cooperation Council (GCC), Rest of World (ROW) as Applicable for Digital Pathology Solutions
• Lead Submission Processes for Regulatory Applications for New Products and Services to Project Timelines for All Markets, to the Applicable Regulatory Bodies: US (FDA, CMS-CLIA), UK (CQC), EU, Canada, MENA, ROW 
• Lead Communications and Engagement with Notified Bodies, Competent Authorities, and International Regulatory Authorities, Regarding Regulatory Submissions, License Applications, Vigilance and Compliance Activities
• Write and Submit Periodic Regulatory Reports to Authorities for Regulatory Purposes
• Establish, Manage and Monitor the Global Regulatory Registrations Database, Keeping the Product Portfolio in Compliance with Global Regulations 
• Keep Up to Date on Revised and Interpret New Medical Device/Medical Services Regulations and Standards, Develop Internal and Global Policies and Procedures to Ensure Continuous Compliance with All Regulatory Requirements and Determine Impact on Company Activities
• Support Staff in the UK, USA and Other Company Locations with Regulatory Queries, Customer Audits, Regulatory Audits and Inspections and Perform Internal Audits
• International Travel, (Approx 10%), to Support Regulatory/Customer Audits

REQUIRED (Essential)

• Degree in a Life Science Subject
• 5+ Years’ Experience in Regulatory Affairs in a Highly Regulated Life Science Sector, (Pharma, Medical Device, IVD etc)
• 3+ Years of Supervisory or Management Experience
• Direct Experience of Successfully Leading the Regulatory Submission Processes
• Experience with MENA, GCC Countries, UAE and Saudi Arabia, will be a Distinct Advantage
• Experience with a Recognised Quality Standard eg ISO 13485 and/or ISO 9001
• Experience with GLP Regulations and Software
• Experience with Delivering Training

REMUNERATION

• £60K, Subject to Qualifications and Experience, with an Excellent Benefits Package

RESPOND

• Call Luke Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail luke@arxconsultancy.com with Your Application, Including Your Current CV