Regulatory Affairs Specialist

Are you looking for a great career and want to make your mark? Please keep on reading but don’t just take our word for it.

We’ve interviewed colleagues around the world about their jobs, the Mölnlycke unique culture and Mölnlycke people and it is simply A great company to work for!

Could you help improve healthcare outcomes around the world? If the answer is yes, you think just like us and should apply for this exciting opportunity that we have below.

We are now looking for a Regulatory Affairs Specialist to play a critical role in our global Regulatory Affairs team. Reporting to the manager for Strategic Regulatory Affairs within Global Regulatory Affairs this position is located at HQ in Gothenburg.

The ideal candidate for this position must be able to integrate business objectives and product development with regulatory requirements. The Regulatory Affairs Specialist will define and manage all regulatory aspects of projects and medical device submissions to Health Authorities worldwide.

Key Accountabilities

As a Regulatory Affairs Specialist your role will include:

• Being the Regulatory Affairs responsible in projects developing new products, line extensions and upgrades according to product launch plan
• Being the Regulatory Affairs consultant and coordinator supporting other functions such as Research & Development to build and mentor best practice
• Reviewing and approving documents necessary for achieving CE-mark and product approval
• Supporting and submitting regulatory applications worldwide to achieve market access
• Monitoring new regulatory regulations as well as changes to existing regulations to secure compliance with regulations for medical devices on a global arena.
• Reviewing and approving labelling as well as claims and marketing messages
• Together with Global Regulatory Affairs secure synergies and optimal resource utilization to support the global company strategy

Qualifications

You should have a university degree, or equivalent, in Chemistry, Biology, Engineering or corresponding experience. You must have experience from medical devices regulations and requirements.

To succeed in this position you must be a really good communicator and possess strong team working skills. Experience from working in an international environment using English on a daily basis, both orally and written is a prerequisite.

You are a good planner and organizer and you do have the ability to establish fruitful relationships and maintain networks as you will be the link between Research & Development and Marketing projects.

The position will report to the manager for Strategic Regulatory Affairs within Global Regulatory Affairs and will be located at HQ in Gothenburg.

This recruitment is handled by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to tom.bergqvist@moveup.se

If you have questions regarding Mölnlycke or this open position, please contact Tom at +46 (0)733 87 27 22. We are screening applications continuously. Please send your CV and Cover letter no later than 16 January.

By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.