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Clinical Evidence Evaluation Manager

Gothenburg, SE

Ref. number:  1255

 

 

Do you want to enjoy what you do – for real – every day? If the answer is yes, you think just like us. In our daily work, we create unique medical solutions to improve quality of life. We enjoy what we do because it makes a difference in people’s lives – for real. Mölnlycke is a world leading supplier of disposable products and solutions that help healthcare professionals achieve the best patient-related, clinical and financial outcomes. We design and deliver products and solutions for wound care, pressure ulcer prevention and surgery. Our products and solutions are cost-effective, which is supported by both clinical and health economic evidence. We are now expanding the business and have high ambitions for the future. Do you want to be part of this exciting journey?  


The Medical & Economic Affairs department covers medical, clinical and health economic aspects of Mölnlycke Health Care’ s medical devices and is an important part of the organisation. There are several interesting development projects ongoing where clinical investigations and clinical evaluations are performed. 


We’re looking for a Clinical Evidence Evaluation Manager who will be responsible for the development of Clinical Evaluations (plans and reports) for new and existing medical devices. This includes performing literature reviews and analysis and interpretation of results from clinical investigations and scientific publications with regards to clinical performance and safety of our medical devices in accordance with applicable regulatory requirements.

 

Key Accountabilities


•    Work cross-functionally with R&D, marketing, regulatory affairs and M&E and provide relevant clinical input to development projects, design control activities and documents as applicable. 
•    Responsible for planning, coordinating and performing Clinical Evaluation Plans and Clinical Evaluation Reports in product development projects and life cycle management activities.
•    Perform literature searches in various scientific literature databases and safety databases.
•    Review and appraisal of published literature specifically applicable to the safety and performance of medical devices.
•    Optimise the use of clinical evidence to support clinical performance and safety of Mölnlycke´s medical devices.
•    Work with contractor(s) and coordinate outsourcing of Clinical Evaluations as needed.

 

Required Qualifications


•    Relevant medical/scientific academic background on MSc/ PhD level or equivalent.
•    Experience in Medical Device or Pharmaceutical industry preferably within Clinical Research/Clinical Evaluations. 
•    In depth knowledge of scientific literature search strategies and performing scientific literature reviews.
•    Knowledge of medical devices standards and registration process.
•    Knowledge of MDD 93/42/EEC, MEDDEV 2.7/1 Rev. 4, MDR, MEDDEV 2.12/2 rev 2 and ISO 14155:2011 is meritorious
•    Solid writing skills, as well as familiarity with medical terminology.
•    Good networking skills.
•    Ability to work in an international environment
•    Fluency in English (written and spoken).

 

This is a full-time permanent position based in Gothenburg. Closing date for applications is 31st of January but we 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 home care, proving 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.