At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
In this role you will focus on supporting regulatory affairs field actions and addressing inquiries from the Competent Authority customers tenders marketing and sales teams. You will also provide guidance and advice to the sales team to ensure compliance with EU and local legislation in the Benelux specifically related to Post-Market Surveillance activities.
You will report to the Regulatory Affairs Manager. The position requires a minimum of two days per week working from the office in Eindhoven Maastricht or Heerlen.
Responsibilities may include the following and other duties may be assigned:
- Preparation execution and follow-up of FSCAs (Field Safety Corrective Actions) according to the enterprise plan. Close collaboration with sales managers and sales representatives to collect/record evidence enabling timely closure of the Benelux FSCAs. Reconciliation activities in collaboration with the FSCA Support Team
- Follow-up on inquiries from the Competent Authority related to Field Action or Vigilance activities including updating Medtronic reporting systems and maintaining accurate record-keeping
- Support on Post-Market Surveillance by advising sales team members on product complaint handling processes and returns to ensure compliance with Regulations and Medtronic procedures
- Monitoring the shared mailbox to provide support for tender requests customer inquiries and internal stakeholder requests
- Sourcing verifying and providing regulatory documents to customers and other stakeholders
- Connecting requests to the appropriate Operating Unit and ensuring complete follow-up
- Participation in team and process improvement initiatives
Required Knowledge and Experience:
- 3-5 years of experience in medical device regulatory quality or product-related roles or a relevant university degree in Regulatory Affairs Pharmacy Engineering or another scientific discipline
- Proficient in Microsoft Office (with advanced Excel skills) and capable of effectively using custom organizational software
- Autonomous proactive detail-oriented and committed to continuous learning and self-improvement
- Strong administrative and organizational abilities clear and effective communication in English with additional proficiency in French Dutch and/or German
- Quality-driven high integrity innovative mindset excellent time management interpersonal effectiveness and a passion for delivering excellence while confidently proposing smarter ways of working
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. 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: 43200.00 EUR- 64800.00 EUR
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About Medtronic
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 95000 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.
Learn more about our business mission and our commitment to diversity here