Compliance and Software QMS Manager

Responsibilities

• Compliance Manager to maintain and update companies certification programme and also ensure QMS across the design and development departments as per the certification protocols.
• Anticipate internal and external audit requirements in advance.
• Keep abreast of changing regulatory requirements and appropriately adjust the scope of the IT Compliance program to accommodate these changes.

Requirements

This role includes all of the requirements above, plus

• Identify, maintain, and publish the requirements for the IT department to achieve compliance and privacy standards including FDA 510K, ISO 13485, ISO 27001, CE, IEC 62304 GDPR and other standards.
• Proven ability to create new IT Compliance programs particularly with respect to QMS and deliver successful results.
• Proven experience building IT Compliance programs from the ground up.
• Proven experience with successful first-time internal and external audits.
• Detailed and comprehensive knowledge of all tools, service, and infrastructure.
• Experience working with leadership to execute on IT Compliance processes and procedures.
• Experience building and maintaining corporate IT Compliance policies and processes.