Regulatory Affairs Manager

Join our team where we bring out the best in people in our effort to make a difference.
We have a strong culture vision that permeates our work and inspires us to commit ourselves, teamwork is our way, we challenge and explore and joy is our spice.
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.
be responsible for product classifications, GSPR and review of labeling
take part in projects and monitor regulatory requirements
support in external audits


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.
Background / Qualifications:
minimum 3 years of working within Regulatory Affairs that governs medical device products and business according to Medical Device Regulation 2017/745
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
experience of Quality Assurance related work according to ISO 13485 and/or ISO 9001 is a plus



We can offer you an exciting and challenging job in a company that is committed to make a difference every day.
This position is located at our headquarter in Mölndal, Sweden.
Please apply no later than 3 February 2022. We will review applications continuously, so be sure to send in your application as soon as possible.
Welcome with your application!