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Job titleClinical Compliance Manager
Job typeMeditech
Salary GBP
LocationEurope
Bonus PackageBenefits
Job description

Are you a systematic go-getter who can make accurate decision quickly? Are you passionate about clinical compliance and legislation for medical devices? A market-leading developer of single use instruments is currently looking for a Clinical Compliance Manager to join their team in Denmark.  
 

The company 

Our client has over 80 years of experience and a world-leading reputation in the single-use instruments space, with a focus on high-quality, cost-effective products that improve patient safety. They are rapidly growing and have strong projections for the future and are constantly making investments in new product development. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our client’s products.

 

The role 

As a Clinical Compliance Manager, you’ll lead, plan, and support clinical compliance activities and support both premarket and post market clinical activities within the medical device’s world. You will ensure that quality, speed, and collaboration is balanced together as you execute activities. Over time, the Clinical Compliance group will grow, and you will drive such expansion and build the team under your supervision.  

Responsibilities include: 

  • Serving as the overall subject matter expert in international clinical medical device legislation  

  • Ensure ongoing lean implementation of international clinical medical device legislations 

  • Implementing this legislation into the company’s clinical processes and related procedures  

  • Leading and coordinating audits  

  • Be an expert in Clinical Evaluation Reports, literature searches and medical writing 

  • Supporting innovations and product life cycle activities  

  • Mentoring and training colleagues in gaining relevant knowledge  

 

The requirements 

You’ll have senior level experience in EU/US clinical medical device legislations and guidelines, as well as… 

  • A relevant Degree, e.g., a MSc in Health or similar  

  • A background within Quality Assurance, Regulatory Affairs, Clinical Development processes or similar  

  • Solid experience within medical device development and sustainability is an advantage 

  • Leading by example comes naturally to you  

  • Willing to take ownership and make accurate decisions 

  • A team spirited individual, with a natural desire to drive continuous improvement  

  • Comfortable working in a challenging environment  

  • Strong business acumen with analytical and organisational skills

  • Able to develop strong relationships with stakeholders at all levels

  • Strong written and verbal English communication skills 

  • Willing and flexible to travel internationally (10-20 days per year)  

 

Important information 

FMC contact for the role: Charlotte Ashton (charlotte.ashton@fmctalent.com)

Reference number: 11425

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    Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.