Regulatory Affairs Manager
Dentsply Ih Ab - Wellspect Healthcare / Apotekarjobb / Mölndal
2017-10-03
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About the position
As a member of our team of Regulatory Affairs Managers you will be responsible for the regulatory compliance of the medical device products manufactured by Wellspect. You will be part of the Quality, Regulatory & Sustainability Affairs department. You will assist our current markets and handle international registrations and work closely with Research & Development, Marketing and Sales to develop regulatory strategies to ensure market access. The daily duties consists of product classifications, review of labeling, incident reporting, acting as regulatory member in projects and monitoring of regulatory requirements on the markets where Wellspect is or will be present.
Good to know
We can offer you an exciting and challenging job in a company that is committed to make a difference every day. We have a culture of team spirit where sharing knowledge and finding new ways to tackle challenges together is the key.
Who you are
We think you are a positive, proactive and pragmatic team player. You are an authority within the field and are used to work as an independent expert. You have excellent communication skills and enjoy working together with colleagues in all parts of the organization.
We believe that you have:
• An academic background with a university degree
• Documented experience with regulatory work in one or more areas in regulatory affairs in the healthcare industry
• Good knowledge of regulations and procedures that governs healthcare, preferably medical device
• Excellent written and verbal communication skills
• Excellent English and Swedish knowledge
It is an advantage if you have experience from FDA requirements, legislation in Asia and in the Middle-East.
Wellspect 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.
Publiceringsdatum2017-10-03ErsättningIndividuell månadslön
Så ansöker duSista dag att ansöka är 2017-10-15
Klicka på denna länk för att göra din ansökanKontaktHerman Fahlström +46 31 376 33 76
FöretagDENTSPLY IH AB - Wellspect HealthCare
AdressDENTSPLY IH AB - Wellspect HealthCare
Box 14
43121 Mölndal
KontorsadressAminogatan 1
Jobbnummer 3729519
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