Regulatory Operations Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

The Regulatory Operations Specialist is responsible for compliant product release and quality-related activities to ensure products can be released and distributed in alignment with internal requirements and agreed service levels. This role works cross-functionally with Quality Regulatory Supply Chain and other stakeholders with a strong focus on Corrective Actions Preventive Actions (CAPA) execution support structured root cause analysis and high-quality documentation.

The position is hybrid and based in Maastricht The Netherlands (currently a mix of on-site and remote work).

Responsibilities may include the following and other duties may be assigned:

• Execute and coordinate compliant Regulatory Product Release activities in SAP Global Trade System (GTS) ensuring accuracy timeliness and adherence to defined processes and service levels.
• Conduct CAPA activities end-to-end including compiling information supporting investigations documenting actions and tracking follow-up through closure.
• Identify and drive process improvements applying structured problem-solving and contribute to thorough root cause analysis to address recurring or complex compliance/quality issues.
• Partner with cross-functional teams to resolve issues efficiently remove roadblocks and prevent recurrence through sustainable corrective and preventive actions.
• Support automation/digitalization opportunities for regulatory operations data and workflows where beneficial.
• Contribute to knowledge sharing training support and continuous improvement initiatives within the team.

Required Knowledge and Experience:

• Bachelors degree (or equivalent experience).
• Fluency in English (written and spoken).
• Experience with SAP GTS and proficiency in Microsoft Office (Outlook Excel Word PowerPoint).
• Demonstrated experience in a regulated environment with strong quality mindset and attention to detail and proven ability to produce high-quality documentation and maintain accurate records.
• Experience collaborating across functions and communicating clearly with stakeholders at different levels.

Quality background (e.g. experience working with QMS processes audits deviations CAPA) strong experience with root cause analysis methods and driving well-documented investigations and experience working in global teams and supporting standardized ways of working are considered advantages for this role.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

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Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Netherlands: 52400.00 EUR- 78600.00 EUR

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).