Regulatory Affairs Specialist

Oldham, GB Gothenburg, SE

Ref. number:  5030

Grow your career in an international environment

 

If you’re ready to have an impact in a career that makes a difference, Mölnlycke could be your next step. You’ll be helping to equip medical professionals around the world with solutions to improve outcomes for patients. And you’ll be developing yourself in a global environment with an inspirational culture, with lots of opportunities. All the while building a successful career, with real purpose. In ORS at Mölnlycke, we aim for frictionless flow in the operating room, with solutions designed for safety.

 

Are you ready to challenge yourself in a new environment and have a real impact?

 

As a Regulatory Affairs Specialist you’ll be joining a successful company to match your own ambitions where there is great opportunity and variety in activity day to day, including

 

  • RA Responsibility within projects for new product development and 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.
  • Together with Global Regulatory Affairs secure synergies and optimal resource utilization in order to support the global company strategy 

 

What you’ll get

 

  • We offer a competitive compensation package in line with local geographical employment regulations, which include salary, pension and healthcare.

 

What you’ll need

 

  • Demonstrable Regulatory Affairs experience within a medical device environment
  • Knowledge of recent UK Medical Device Regulations (MDR) directive
  • Experience using a Product Lifecycle Management (PLM) system
  • Understanding of wider global medical regulations would be beneficial
  • Previous exposure to medical devices such as gowns or drapes is desirable

 

Your work-life / Your work-life balance

 

  • Role operates a hybrid working pattern with 3 days in the office and 2 days from home
  • Hours can be flexible around core 10:00am – 4:00pm schedule

 

Our approach to diversity and inclusion

 

We strive to have a diverse mix of people from different cultures, ages, geographies and genders, to reflect the world in which we operate and to facilitate innovative thinking across the business.

 

Please contact Matthew Davitt if you have any questions about the role or wish to discuss opportunities at Mölnlycke further

 

 

About Mölnlycke

 

Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes.

 

Our business is organised in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do.

 

Mölnlycke employs around 8,400 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers