Regulatory Affairs Manager

Join our team where we bring out the best in people in our effort to make a difference.

As Regulatory Affairs Manager you are responsible for the regulatory compliance of urology and enterology products manufactured by Wellspect HealthCare.

Responsibilities:
support the Wellspect HealthCare organization with regulatory knowledge during product development, market launches, compiling documentation and Vigilance/MDR Reporting.
be responsible for international product registrations and maintenance.
prepare international applications, product classifications and review of labeling
take part in projects and monitor regulatory requirements


Qualifications / Background;
We believe that you have:
minimum 3 years of working within Regulatory Affairs and/or Quality Assurance with knowledge of regulations that governs medical device products and business
a careful, responsible and structured way of working
good communication, writing and interpersonal skills with the ability to manage multiple projects and work independently
full command of the English language, both written and spoken


We think you are an energetic and analytic person who likes to take initiatives and decisions. You are open for challenges and enjoy working together with highly skilled and committed colleagues where every day makes a difference.

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.
This position is located at our headquarter in Mölndal, Sweden.

For more information, please contact recruiting manager, Annika Loid, telephone +46 761 435713.

Please apply no later than 17 January 2021. We will review applications continuously, so be sure to send in your application as soon as possible.

Welcome with your application!