Regulatory Affairs Program Manager Vacature bij Medtronic Heerlen
Medtronic Heerlen met spoed nodig onderstaande werk positie als de Regulatory Affairs Program Manager. Lees deze personeelsadvertentie zorgvuldig alvorens het aanbrengen van. Er zijn enkele kwalificaties, ervaringen en vaardigheden eisen dat de werkgevers nodig hebben. Doet je carrière geschiedenis passen deze eisen? Ervoor begrijpen dat u de rol die je solliciteert en dat zorg ervoor dat het geschikt is met uw vaardigheden en kwalificaties te.
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Regulatory Affairs Program Manager Vacature bij Medtronic Heerlen Vacatures Detail:
At Medtronic, we strive without reserve for the greatest possible reliability and quality in our products. To help ensure our patients safety and health, we closely monitor and report on our products’ performance. The Post Market Surveillance department in Heerlen is responsible for addressing clinical/technical product inquiries and product experience reports for EMEA. ,
A Day in the Life
We offer you a position where you play a pivotal role in an exciting and dynamic regulatory affairs environment.
You are the liaison between the regulatory and quality teams at the group or business level (representing the Manufacturer) and the European authorities. You will ensure the duties and requirements of the European Authorised Representative are carried out according to the European Directive and, in future, European Medical Device Regulation (MDR).. You will act as specialist contact point for one or several Medtronic groups (Cardiac & Vascular, Restorative Therapies, Minimally Invasive Therapies or Diabetes), understanding the products and therapies in order to act on the groups behalf in the region with regulatory authorities and also to support and advise the EMEA Regulatory team and local Regulatory teams in their daily work (perform training, expert content reviews and handling critical cases).
You will draft and/or review responses to a authority questions and requests about submitted reports (vigilance, field actions, summary reports and plans), feedback from customers or other pre and post market surveillance data. .
You will help Medtronic build professional working relationships with the European Authorities. You will be required to and speak with or meet directly with the Authorities as and when required on behalf of Medtronic or support senior leadership in such meetings.
You make sure all relevant internal stakeholders (group/business teams, central and local Regualtory teams) have the information they need to carry out their roles, for example; EU vigilance requirements & training, access to product/therapy information and training and post market, risk management and field action data).
You are a regulatory affairs professional with experience working with regulators and/ or working in a legal environment. You are an excellent communicator, very diplomatic, and enjoy working with a wide diversity of cultures and nationalities. You can work on cases of varying complexity and scope, learn quickly and can simply and concisely share information.
• Bachelor or Master degree or equivalent in a science discipline such as Biology, Physics or Biomedical Engineering, and/or Quality and Regulatory Affairs.
- Self-motivated, self-directing, strong attention to detail and execution.
- Strong interpersonal and leadership skills
- You have solid diplomacy skills for working with regulators, customers and trade associations
- 5-10+ years relevant working experience.
- Fluent English.
Nice to Haves
• Medical Devices industry experience
- Legal experience
- Clinical experience
- Experience in Post Market Surveillance
- Fluency in other European Languages
Is this the position you were waiting for? Then please apply directly via the apply button!
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
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Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 89,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. With our European Operations Center for Distribution and Shared Services in Heerlen, the Bakken Research Center in Maastricht, our manufacturing facility in Kerkrade, and the Dutch sales office in Eindhoven, Medtronic Netherlands has more than 1,750 employees.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.