Regulatory Affairs Manager

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 Systems?, 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.

We are looking for a new member of our global team of Regulatory Affairs Manager. Will it be you?

We are a team of colleagues that commit ourselves, challenge the existing and work as a team with joy as a guiding principle. 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 HealthCare. You will be part of the Quality, Regulatory & Sustainability Affairs department and located at our headquarters in Mölndal, Sweden.

DESCRIPTION
This role supports the Wellspect HealthCare organization with regulatory knowledge during product development and market launches, compiling documentation and is responsible for international registrations. You will be working 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 HealthCare is or will be present.

QUALIFICATIONS
We are looking for a new employee with a university degree and who is knowledgeable in the regulations that governs the med tech products and business. If you are an energetic and an analytic person who is used to take initiatives and make decisions you will fit well in this role. As you will have a lot of international contacts both within and outside the company we require that you have full proficiency in English and good command of Swedish, both in speech and writing.

INFORMATION
You are welcome to contact Herman Fahlström, recruiting manager, +46 (0) 31 376 33 76, for questions or queries.

We will need your application at October 30 at the latest. We evaluate applications continuously and we will therefore be happy to see your application as soon as possible. Welcome with your application!