RA Specialist

WORKING AT MÖLNLYCKE
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. 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 in order 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 in order 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 Device Companies for at least five years and at least three years of experience working with regulations and requirements for medical devices, from Regulatory Affairs or related areas.
In order to succeed in this role 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.

Closing date for applications is 31st of August, but have an ongoing review of candidates.

About Mölnlycke
Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.
We specialise in:
• Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
• Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients
• Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves
Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.