workday
Posted 2 weeks ago
Regulatory Operations Specialist
Job description
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 95,000 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. A Day in the Life 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
Bachelor’s 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. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
Benefits
& Compensation 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: 52,400.00 EUR - 78,600.00 EUR | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com