Senior Regulatory Affairs Specialist, Post Market Surveillance
One of the main objectives for working in this position is that the company policy is to strive without reserve for the greatest possible reliability and quality in our products. To help ensure our patients safety and health, you will closely monitor and report on the products’ performance. The Post Market Surveillance department is responsible for addressing clinical/technical product inquiries and product complaint reports for Europe, Middle East, Africa, South-Asia and Latin America.
In this position you are responsible for preparing field action (FSCA) packages and coordination. You ensure regulatory/vigilance reporting accuracy and timeliness for assigned business units products complaints and compliance with the regulatory requirements and procedures. Further, you serve as the liaison between regions and business units to investigate and prepare response to questions from competent authorities or customers. The scope of this position would be EMEA, LatAm and India.
The candidates we are looking for have at least obtained a Master's degree, preferably in Life Sciences. In your career you have demonstrated your technical skills in a medical industry for at least 5 years. In order to be successful in this position you need to have acquired suitable knowledge about regulatory requirements especially in the area of vigilance, medical device reporting and post market surveillance. Furthermore you need to have extensive knowledge about Medical Device Regulations.
We are looking for a self-motivating and –directing person with a strong attention to detail. You have excellent organizational and time management skills and function as a strong communicator.
Our client offers you a professional, international, dynamic and high quality working environment, where personal development is stimulated and personal initiatives are encouraged. Your Development Plan will challenge you to further develop your personal skills and competencies, to build your career within our global organization.
Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals. Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects for our clients in the Dutch “Brainport” Eindhoven region, mainly on projects at our clients’ Research & Development departments. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer +31 0655724609
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.