Management System Representative - Healthcare Regulatory Services

CSA Group Healthcare Testing & Certification GmbH is looking for a Management System Representative (m/f/d) to join our Healthcare Regulatory Services team in Germany.

You will take a central operational role in maintaining and developing the CSA HTC quality management system. Our activities operate in a highly regulated environment covering medical devices and in vitro diagnostic medical devices, and your work will help ensure that our organisation, processes and records remain effective, traceable and ready for regulatory and accreditation assessments.

You will report to the Director, Healthcare Regulatory Services and work across the organisation with process owners, programme teams, internal auditors, Corporate Quality and other support functions.

This is not primarily a product-assessment or certification-decision role. Your focus will be the quality system that enables those activities to be performed consistently, independently and compliantly.

These are your duties:

• Coordinate the implementation, maintenance and continual improvement of the CSA HTC quality management system.
• Translate applicable MDR, IVDR, accreditation and other regulatory requirements into practical and controlled QMS processes.
• Maintain effective document and record control, including document hierarchy, revisions, approvals, applicability, retention and archiving.
• Coordinate the internal audit programme, including audit planning, auditor independence, findings and follow-up of corrective actions.
• Coordinate quality events, nonconformities and CAPA, including root-cause analysis, corrective actions and effectiveness verification.
• Coordinate the management review process, prepare relevant QMS performance information and follow resulting actions through to completion.
• Maintain meaningful QMS performance indicators and identify recurring findings, overdue actions and systemic risks.
• Coordinate the controlled handling and appropriate allocation of complaints and appeals.
• Support controlled implementation of QMS changes, including regulatory-impact assessment, communication and training.
• Work with process owners and Finance on regulatory performance-monitoring requirements, including applicable reporting on conformity-assessment timelines and costs

What we expect:

• We are looking for someone who combines regulatory understanding with practical quality-management experience.
• A university or technical-college degree, or an equivalent professional qualification, in quality management, engineering, science, healthcare, regulatory affairs, business administration or another relevant field.
• At least 5 years of relevant professional experience in quality management, certification, conformity assessment, regulatory compliance or another regulated environment.
• At least 2 years of practical experience working with a quality management system, including areas such as document control, management review, internal audits and corrective-action processes.
• Practical knowledge of the EU Medical Device Regulation (MDR) and/or In Vitro Diagnostic Medical Device Regulation (IVDR) and an understanding of how regulatory requirements affect the operation of a conformity assessment body.
• Experience with nonconformity management, root-cause analysis, corrective actions and effectiveness checks.
• Experience with internal auditing, including evaluation of objective evidence and follow-up of findings.
• The ability to analyse complex regulatory or organisational requirements and turn them into workable processes.
• Strong organisational and analytical skills and the ability to manage several topics and deadlines in parallel.
• Sound professional judgement and the confidence to challenge non-compliance constructively when necessary.
• Strong communication skills and the ability to work effectively with colleagues at different organisational levels and across functions.
• Professional proficiency in English.

Additional experience that would be useful:

• Medical-device or IVD conformity assessment.
• Notified Body or certification-body quality systems.
• ISO/IEC 17021-1.
• ISO 13485.
• IAF MD 9 or other applicable IAF Mandatory Documents.
• Regulatory or accreditation assessments.
• Formal internal-auditor or lead-auditor training.
• Working with Corporate/global processes in a regulated legal entity.
• German language skills.

What we offer

• A central role in the development and operation of a highly regulated quality management system.
• Direct interaction with top-level management, regulatory programme teams and quality professionals.
• The opportunity to influence how regulatory requirements are translated into effective day-to-day processes.
• A collaborative international working environment within CSA Group.
• Flexible working arrangements and the opportunity to work from home.
• Ongoing professional development and learning opportunities.
• Company pension plan and additional Corporate benefits.
• Permanent employment.
• Travel to CSA HTC locations and external audit or assessment locations may be required depending on business needs.
• Prepare the QMS and supporting evidence for regulatory, designation, accreditation and other external assessments and coordinate follow-up activities.
• Ensure that Corporate or global policies, procedures and systems used by CSA HTC are appropriately assessed and integrated into the local regulatory framework.
• Escalate material QMS, compliance, independence or implementation risks where necessary.
• Act as a constructive quality partner for colleagues throughout the organisation while maintaining the independence and objectivity required for the role.