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 http://www.wellspect.com and http://www.dentsplysirona.com for more information.
Regulatory Compliance Manager
We are currently looking for a Regulatory Compliance Manager to strengthen our organization. The candidate will work in an international environment with enthusiastic people and continuously develop our business to meet new demanding requirements.
- Develop strategies and plans for registration of new or changed products in close cooperation with the registration holders in the target countries.
- Represent the department in Product Development Projects (including medical device software), line extensions and any changes/upgrades of products in the product portfolio to guide and support the organization with regulatory advice for market access.
- Compile registration documentation and manage registration of new / changed products according to the company strategies and plans.
- Review device labeling, labels and advertising material for compliance with regulatory requirements and applicable laws.
- Perform classification of Products.
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.
For this role in a truly global business environment, we look for qualified candidates with analytical skills and open for generate creative solutions in a regulated Medical Device Industry.
- A university degree in engineering or an equivalent professional background.
- Experience from writing regulatory applications for medical devices products for entering the USA and Canada markets.
- Experience from working in a medical device industry and have knowledge about ISO 13485 and 21 CFR.
- Experience from Medical Device Directive 93/42/EEC and insight into Medical Device Regulation (MDR 2017/745).
- Fluent in English is a requirement.