Associate Regulatory Affairs Specialist

Medtronic; Eindhoven; Hybrid; EUR 44,000 - 66,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Flexible work arrangement

Job summary

Medtronic Benelux is seeking an Associate Regulatory Affairs Specialist to support post-market surveillance, vigilance, and regulatory compliance across the Benelux region. You will collaborate with quality and regulatory teams to ensure patient safety and adherence to ISO 13485.

The role is based in Maastricht or Heerlen, with a flex work arrangement requiring presence in Eindhoven or Heerlen twice per week and occasional travel within the territory.

Qualifications

• Bachelor's degree with 0+ years of experience in Regulatory Affairs, Quality, Life Sciences, Biomedical Sciences, Healthcare, or a related field.
• Fluency in English and Dutch, both written and spoken.
• Advanced proficiency in Microsoft Office applications and database systems.
• Experience managing multiple priorities with strong organizational and administrative skills.

Responsibilities

• Coordinate the preparation, execution, and follow-up of field safety corrective actions and product hold activities within the Benelux region.
• Manage inquiries from competent authorities related to vigilance activities and field safety corrective actions.
• Advise sales teams on product complaint handling and product return processes in compliance with regulatory requirements and company procedures.
• Support Quality Management System activities, including supplier management, distributor management, document control, and key performance indicator monitoring.
• Monitor regulatory developments and support implementation of new regulatory requirements affecting the Benelux region.
• Manage shared regulatory mailboxes and respond to internal, tender, and customer requests.
• Support promotional and marketing activities by reviewing materials for regulatory compliance.
• Collaborate with regional and global Quality and Regulatory teams on compliance initiatives and process improvements.

Skills

Regulatory Affairs

English

Dutch

Organizational skills

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Database systems

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 Affairs function within Medtronic Benelux supports compliance with medical device regulations and quality requirements across Belgium, the Netherlands, and Luxembourg. Working closely with commercial, quality, and regulatory teams, the function helps ensure patient safety, effective post-market surveillance, regulatory compliance, and timely engagement with competent authorities and customers. This position is based in Maastricht or Heerlen, Netherlands, and follows a Flex work arrangement, you are expected to work from the Eindhoven or Heerlen office twice per week. The role supports stakeholders across the Benelux region and may require limited travel within the territory as business needs arise. As an Associate Regulatory Affairs Specialist, you will support Quality and Regulatory Compliance activities across the Benelux region. You will work with experienced Regulatory Affairs professionals to support post-market surveillance activities, field safety corrective actions, interactions with competent authorities, and quality management system processes. The role requires strong organizational skills, attention to detail, and effective collaboration with commercial and operational teams.

Primary Responsibilities

• Coordinate the preparation, execution, and follow-up of field safety corrective actions and product hold activities within the Benelux region.
• Manage inquiries from competent authorities related to vigilance activities and field safety corrective actions.
• Advise sales teams on product complaint handling and product return processes in compliance with regulatory requirements and company procedures.
• Support Quality Management System activities, including supplier management, distributor management, document control, and key performance indicator monitoring.
• Monitor regulatory developments and support implementation of new regulatory requirements affecting the Benelux region.
• Manage shared regulatory mailboxes and respond to internal, tender, and customer requests.
• Support promotional and marketing activities by reviewing materials for regulatory compliance.
• Collaborate with regional and global Quality and Regulatory teams on compliance initiatives and process improvements.

Required Qualifications

• Bachelor's degree with 0+ years of experience in Regulatory Affairs, Quality, Life Sciences, Biomedical Sciences, Healthcare, or a related field.
• Fluency in English and Dutch, both written and spoken.
• Advanced proficiency in Microsoft Office applications and database systems.
• Experience managing multiple priorities with strong organizational and administrative skills.
• Ability to work accurately with high attention to detail in a regulated environment.

Preferred Qualifications

• Knowledge of French or German.
• Knowledge of medical device regulations, post-market surveillance, or vigilance processes.
• Experience working within a Quality Management System certified to ISO 13485.
• Experience supporting regulatory, quality, or compliance activities in the healthcare or medical device industry.
• Proactive working style and ability to work effectively in a multicultural environment.

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.

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.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Netherlands: 43,840.00 EUR - 65,760.00 EUR | The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework.

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 settingis 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.