Associate Regulatory Affairs Specialist

Medtronic; Eindhoven; Híbrido; EUR 44.000 - 66.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible Benefits Package

Hybrid work arrangement

Descripción de la vacante

Medtronic plc is seeking an Associate Regulatory Affairs Specialist in the Netherlands. The role supports regulatory and quality activities across the Benelux region with a flexible hybrid work model, based in Maastricht or Heerlen, and with occasional travel.

Fluency in English and Dutch is required, along with a Bachelor’s degree and strong organizational skills. You will coordinate field safety actions, respond to authorities, and assist in QMS processes, while collaborating with

Formación

• Bachelor's degree in a related field or equivalent experience.
• Fluency in English and Dutch, both written and spoken.
• Strong organizational and administrative capabilities in a regulated environment.

Responsabilidades

• Coordinate regulatory activities across Benelux (Netherlands, Belgium, Luxembourg).
• Support post-market surveillance and vigilance processes.
• Assist with quality management system activities and document control.
• Review promotional materials for regulatory compliance and liaise with authorities.
• Support inquiries from competent authorities and supplier/distributor management.

Conocimientos

English proficiency

Dutch proficiency

Attention to detail

Organizational skills

Educación

Bachelor's degree

Herramientas

Microsoft Office

Descripción del empleo

## Associate Regulatory Affairs SpecialistApply: Flexible Work Arrangement: Eindhoven, Noord-Brabant, Netherlands: Heerlen, Limburg, Netherlands: Full time: Posted Today: R76733Careers 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.**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 [e-mail].# **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: 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.