EMEA Compliance & Process Improvement Lead

KRK Medtronic B.V.; Heerlen; On-site; EUR 65,000 - 98,000; Full time

Job summary

Medtronic is looking for a Sr. Process Compliance Specialist based in Heerlen, the Netherlands. The role emphasizes ensuring ongoing compliance with quality standards, regulations, and company policies across the S&R EMEA organization, and driving process improvements in a global setting.

The position requires 2 days on-site and relocation is not provided. You will lead compliance programs, facilitate reviews, provide data to management, monitor metrics, and support audits and inspections, all

Qualifications

• Bachelor’s degree with a minimum of 4 years of relevant experience, or a Master’s degree with a minimum of 2 years of relevant experience in Quality, Compliance, or Process Improvement.
• Experience in medical device or similarly regulated industry.
• Fluent written and spoken English language.
• Experience in planning, coordinating, communicating, influencing, achieving milestones, resolving issues.
• Ability to work in a cross functional and global environment and cultural awareness.
• Good communication and interpersonal skills and ability to work independently.
• Proven experience in cross-functional stakeholder management.
• Project management skills.
• Good presentation skills.

Responsibilities

• Ensure ongoing compliance of the S&R EMEA Organization to requirements originating from applicable Quality standards, regulations & policies.
• Facilitate Compliance Management reviews at prescribed intervals each fiscal year to review the continuing suitability, adequacy, and effectiveness of the S&R EMEA Organization’s Compliance strategies and programs.
• Provision of relevant information and data to S&R EMEA management, that facilitates evaluation of the adequacy and effectiveness of current compliance strategies and programs.
• Monitor compliance metrics and identify improvement opportunities.
• Collect and analyze data to identify root causes of compliance issues and performance shortfalls.
• Ensure timely and effective follow up of compliance actions (e.g. CAPA, Change Control, Regulatory actions etc.).
• Act as a Compliance SME ensuring a first-time right approach to activities affecting compliance to requirements.
• Support compliance audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
• Prepare reports and/or necessary documentation to meet requirements and ensure applicable (internal and external) stakeholders are adequately informed.
• Plan, perform, and implement process improvement initiatives to enhance compliance and operational efficiency.

Job description

Medtronic is looking for a Sr. Process Compliance Specialist based in Heerlen, the Netherlands. The role emphasizes ensuring ongoing compliance with quality standards, regulations, and company policies across the S&R EMEA organization, and driving process improvements in a global setting.

The position requires 2 days on-site and relocation is not provided. You will lead compliance programs, facilitate reviews, provide data to management, monitor metrics, and support audits and inspections, all