Heerlen, NLD
5 days ago
Associate Regulatory Affairs Specialist
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll 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 FSCA's (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 FSCA's. 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: 43,200.00 EUR - 64,800.00 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 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. Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) 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 (https://www.e-verify.gov/employees) . 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
Confirmar seu email: Enviar Email
Todos os Empregos de Medtronic