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Product Complaints Specialist

Date: 08-Jun-2021

Location: Gothenburg, SE

Company: Mölnlycke Health Care

Does helping to make life better for millions of people motivate you?  

If the answer is yes, you think just like us. We are a world-leading medical solutions company, designing and supplying medical solutions to enhance performance in healthcare – from the hospital to the home. We’re looking for people who want to improve outcomes for healthcare professionals and their patients. 


We are currently recruiting for a Global Product Complaints Specialist to our HQ in Gothenburg, Sweden.


As a Global Product Complaints Specialist you will ensure patient safety by providing a comprehensive and effective product complaint handling, Field Action planning and execution as well as incident reporting. You will interact and work closely with internal stakeholders around the world within RA, QA, R&D, Operation and Commercial organization.


Key accountabilities: 

  • Drive and coordinate as well as document product complaints activities including receipt, initial assessment, data in feed, analysis, review and follow up 
  • Based on safety assessment of incoming product complaints decide if reportable incident or not and, when applicable, perform incident reporting
  • Interact with internal stakeholders and pro-actively contribute to the Post Market Surveillance plan and other improvement activities 
  • Interact with external stakeholders e.g. Competent Authorities and Notified Bodies regarding incident reporting and other product quality issues  
  • Actively contribute to improvements and development of existing Product Complaints processes and procedures 
  • Participate in audits/inspections and contribute to progress and closure of corrective actions
  • Actively contribute to increased product quality and complaints handling knowledge within the entire organization 


Qualifications & Experience: 

  • Academic background in life sciences, chemistry, quality management or regulatory affairs 
  • Experience from work in an international environment
  • Background in medical devices and/or pharmaceuticals with post-marketing surveillance, complaints handling and/or voice of customer experience 
  • Quality, regulatory and process knowledge and experience in medical devices and pharma regulations 
  • Detail oriented and performance driven with analytical skills 
  • High communication skills with a customer oriented and problem solving mindset 
  • Strong team player with high flexibility 
  • Fluent in English (written and spoken)
  • High computer proficiency 


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 specialize 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 customized trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.