Regulatory Affairs Manager - ABIGO Medical AB

ABIGO Medical AB is committed to improve people’s health and wellbeing. We develop, manufacture, and market medical device products including the Sorbact® technology, which is a clinically established innovation for advanced wound management. ABIGO was founded in 1989 by brothers Jan G. and Leif Smith and is today owned by Essity. The company has about 170 employees and distribution of products in more than 60 countries through own sales organisations and partners.

Are you challenged by finding effective solutions, moving forward and want to be involved in improving people's health and well-being?We are now looking for a new colleague to join our Regulatory Affairs team and to contribute to our medical device segment related to advanced wound management products. As a Regulatory Affairs Manager, you will work in close cooperation with colleagues within Regulatory Affairs (RA), cross-functionally throughout the company, as well as with distributor contacts around the world.
 
RESPONSIBILITIES

• Act as RA representative in design/maintenance projects including making assessments and develop strategies
• Maintain regulatory compliance in current markets through necessary regulatory actions related to product changes and renewals
• Secure continued growth both in current markets through registration of additional products, and in new markets through initial registrations
• Create, review and maintain product related regulatory documentation
• Monitor regulatory requirements internationally
• Contribute to and lead process improvement
SKILLS AND QUALIFICATIONS

• Academic background within life science or other scientific education
• At least five years’ experience within the Life Science industry, and at least three years’ experience within medical device Regulatory Affairs
• Strong communication skills in Swedish and English, both verbally and in writing
• Ability to build and maintain positive, professional relationships cross-functionally and cross-culturally, both internally and with ABIGO's partners
•  Face challenges with a positive and solution-oriented attitude
 
You will be a member of an inspiring and affirmative team, where we help each other and work together towards set goals. We emphasize the importance of working professionally in an environment that is enjoyable and fulfilling. This position is a permanent full-time employment based in Askim, Gothenburg.
 
To apply, please send your CV and a cover letter no later than June 13, 2021. If you have questions regarding ABIGO Medical AB or this open position, please contact hiring manager Marie Skoglund, Regulatory Affairs Director, +46 70 767 31 79.

We are looking forward to hearing from you!