Head of Quality System and Regulatory Affairs

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Do you want to be a part of the development of the quality and regulatory work for a company that is committed to make a difference every day? Join our team where we bring out the best in people in our effort to make a difference.About the positionThe Head of Quality System and Regulatory Affairs (QSRA) is responsible to plan, lead and coordinate the activities of the QSRA group. The responsibility of the group consists of maintaining and continuously improving the quality management system and to ensure regulatory compliance and market access. You will be part of the QARA management team and will be reporting to the Vice President Quality Assurance and Regulatory Affairs.Your key accountabilities are:Ensuring conformity of regulatory processes to local and international regulations as well as applicable standards for medical device.Development and implementation of regulatory strategies.Responsibility for the regulatory processes for new and changed products on a global marketManagement of vigilance and MDR reporting.Continuously develop central QMS processes and quality IT systems.Responsibility for 3rd party audits.Manage, coach and develop direct reports.Actively participate in QARA management team and contribute to QARA functionWho you areWe think you are an analytical yet pragmatic person who are keen on ensuring that the interests of all stakeholders are met. You are decisive and make decisions on a holistic level, with the best for both compliance and organization in mind. You take responsibility for your actions and you know how to create an engaging work environment.We believe you haveBachelor’s Degree in the Sciences or Medical discipline or equivalent.Demonstrated experience in relevant regulations and standards for medical device (FDA QSR, ISO 13485:2016, MDD 93/42/EEC, MDR 2017/745, ISO 14971).Several years of experience from global regulatory affairs and compliance work.Extensive knowledge about QMS processes.Handled several different quality inspections and audits from notified bodies and/or regulating authorities.Previous experience as people manager.Excellent communication, organizational and people management skills.Business-fluent language skills in English and Swedish.Good to knowFor more information, please contact recruiting manager, Herman Fahlström, telephone +46 703568069.Please apply no later than September 22, 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 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.