Regulatory Affairs Specialist

Dentsply Ih Ab - Wellspect Healthcare / Apotekarjobb / Mölndal
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Join our team as Regulatory Affairs Specialist were your contribution can make a real difference in our work towards a world-class organization within regulatory affairs. About the positionAs Regulatory Affairs Specialist your main responsibility is to support the regulatory team to ensure completion of market access, product development and incident reporting. You will also support our market organisations, administrate different regulatory requirements and assist in reviewing technical documentation.Your key accountabilities are:Support our Regulatory Affairs Managers in registrations of our products in a global market.Support our market organisations in regulatory related issues.Provide regulatory support for product complaints and worldwide adverse event reporting requirements.Administration of regulatory requirements.Perform reviews of technical documentation.Monitor regulatory requirements and support organisation in identification of key areas. Who you areYou are a highly structured person, with an eye for accuracy, and like to work in a systematic way in an international environment. You have an ability to listen to the requests of our stakeholders, identify and analyse the problem at hand and act accordingly by your own initiative.We believe you have: A relevant university/scientific degree or relevant work life experience, preferably from Life Science or other regulated business.Experience from a supporting role.A systematic way to manage your time and resources to ensure that work is completed efficiently.Excellent written and verbal communication skills in English and Swedish.Experience in working with different IT-system and supporting tools.For more information, please contact recruiting manager, Herman Fahlström, telephone +46 31 376 33 76Please apply no later than June 10, 2019. Please note that we will review applications continuously, so be sure to send in your application as soon as possible.About Wellspect HealthCareWellspect HealthCare, with headquarters in Mölndal, Sweden, is a leading global provider of innovative medical devices with a focus on helping people suffering from urinary retention or chronic constipation. Every day, more than 1 100 employees are dedicated to make a difference for those who need our products and services. Many of the people we serve have a spinal cord injury, enlarged prostate, spina bifida or multiple sclerosis. We are one of the world's leading manufacturers of intermittent urinary catheters, with LoFric® as our most known brand. As a help to those with chronic or severe constipation we have developed what likely is the world's most advanced irrigation system, the Navina SystemsTM, combining a high degree of user convenience, clinical effectiveness and connectivity into one really smart system. Wellspect HealthCare has a presence in more than 30 countries, and is a part of Dentsply Sirona, the worlds ' largest manufacturer of professional dental products and technologies with global headquarters in York, Pennsylvania, and international headquarters in Salzburg, Austria. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.wellspect.com and www.dentsplysirona.com for more information.

Publiceringsdatum
2019-05-21

Så ansöker du
Sista dag att ansöka är 2019-06-10
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Företag
DENTSPLY IH AB - Wellspect HealthCare

Kontorsadress
Aminogatan 1

Jobbnummer
4801903

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