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Global Product Complaints Manager

Gothenburg, SE

Ref. number:  1243

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’re looking for a Global Product Complaints Manager who will be responsible for ensuring patient safety by providing a comprehensive and effective product complaint handling, trending and incident reporting. In this role you will lead a team and be able to build a broad network within the area.

 

We are looking for a person who is willing to take ownership for the team and drive as well as develop the vigilance, pharmacovigilance and product complaints handling process and competence within the entire Mölnlycke Health Care organisation.

 

Key Accountabilities

 

  • Responsible for the Global Designated Complaint Unit.
  • Lead and coach a team in order to secure continuous development of adequate competence, efficient working methods, optimal resource planning and a stimulating environment, including annual performance planning, talent development and succession planning.
  • Process owner of Global Product Complaints Handling, Field Safety Corrective Actions (FSCA), Vigilance and Pharmacovigilance including supporting tools.
  • Member of FSCA Board at Mölnlycke -responsible for FSCA decisions
  • Represents the Global Designated Complaint Unit and actively participates in internal and external audits/inspections
  • Implementation of changes related to Global Product Complaints and Global Field Action process.
  • Directly and frequently interact with internal and external stakeholders, eg. Competent authorities and Notified Bodies regarding FSCA, incident reporting and other product quality issues.

 

Your Qualifications

 

  • Academic background in life sciences, chemistry, quality management or regulatory affairs
  • A minimum of 5 years experience of handling complaints, incident reporting and field actions preferably in a leading position.
  • Experience from work in an international environment.
  • Strong leadership capabilities and previous leadership experience.
  • You will need deep quality, regulatory and process knowledge within in medical devices and/or pharmaceuticals with post-marketing surveillance, complaints handling and/or voice of customer experience.
  • Experience of Medical Device Regulation (MDR) principles and regulations
  • A clinical background and technical/product knowledge would be advantageous.
  • Knowledge in Good Distribution Practice and Pharmacovigilance is preferable.

 

To be successful in the role you need great communication and networking skills. We are looking for a strong team builder with ability to lead and motivate people in a challenging environment. As a person you are result oriented with high analytical skills and a problem solving mindset. It is also important to be calm in stressful situations and to be able to handle the pressure from both internal and external stakeholders.

 

This is a full-time position based in Gothenburg.

 

We look forward hearing from you.  Don´t hesitate to send in your application as we will have an ongoing review of candidates. We will contact only selected 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.