Deciphex

Director

• Owning the end-to-end client relationship across our UK portfolio, from onboarding new sites through to long-term performance and escalation management.
• Leading cross-functional problem solving when things go wrong, without waiting for someone to assign it to you.
• Working closely with sales to make sure we only commit to what we can actually deliver and pushing back when needed.
• Monitoring SLA performance, surfacing risks early, and communicating clearly and honestly with clients.
• Driving continuous improvement across UK operations, setting standards and working with functional leads to deliver them.
• Representing service performance in governance forums and to senior leadership.

Director of Service Excellence

Compliance

• This is a remote role with some travel required to global offices.
• Actively involved with the Laboratory Operations team, QA/RA team, Commercial, legal and R&D teams to generate regulatory plans and strategies for digital pathology products and services.
• Maintain and implement the compliance plans to ensure continued compliance for our services and products in North America.
• Make submissions for regulatory and accreditation applications for new products/services to project timelines to the applicable regulatory bodies.
• Develop, compile and review the technical documentation required for regulatory submissions: USA, Canada.
• Support Regulatory Affairs team with UK, EU, Rest of World submissions as needed.
• Lead communications and engagement with Notified Bodies, Competent Authorities, and international regulatory authorities.
• Coordinate post market surveillance (PMS) activities for products and services.
• Write and submit periodic regulatory reports to authorities as required.
• Establish, manage and monitor the global regulatory requirements database, keeping the product portfolio in compliance with global regulations.
• Keep up to date on changing regulatory requirements and standards including FDA/LDT rule changes, emerging AI regulations, privacy/security regulations etc.
• Conduct regulatory gap analyses and impact analysis.
• Develop internal and global policies & procedures to ensure continuous compliance with all regulatory requirements.
• Assist in maintaining the Regulatory Affairs Intranet site.
• Collect and report on compliance metrics as directed by the Regulatory Affairs Manager.
• Support other members of the Quality team to incorporate regulatory requirements into the Integrated Management System (IMS).
• Review of Change Requests for product & service changes which may impact regulatory and customer filings.
• Support employees with regulatory queries, customer audits, regulatory audits and inspections as required.
• Perform internal & supplier audits as required.
• Develop and deliver company training modules on regulatory processes.
• Complete all mandatory company training and job specific training required for the role, including Information Security Management System (ISMS), GLP, DocuSign, SDLC as applicable.

Director of Service Excellence

Regulatory Affairs Specialist