Clinical Evidence Manager

Are You enjoying and genuinely good at writing clinical documentation and putting it into context?
Then maybe you are ready for a key role at one of the leading global providers of medical devices within bladder and bowel continence care!
You will be a key member of the Global Medical Affairs department, an agile group of experts, waiting for You to join us in the important work of planning, generating, evaluating and documenting scientific evidence to meet commercial needs and regulatory requirements. If this sounds interesting, please keep reading.
As specialist in putting clinical evidence into a business and regulatory context the role requires deep scientific knowledge, solid medical writing capabilities, integrity and a broad understanding of external requirements/internal strategies. You will specifically manage all clinical evaluation related activities including associated documentation and be a key player in the cross functional evidence planning for Wellspects full range of products.
Responsibilities:
Management of all deliverables related to Clinical Evaluations such as Plans/Reports, State of the Art, PMCF
To provide input on Post Market Clinical Follow-Up initiatives including PMCF-surveys
To optimize the use of clinical evidence to support successful registration, positioning and life cycle management
To represent the function in external (e.g. audits, inspections) and internal (e.g. projects and meetings) forums as subject matter expert
To contribute from early product development and throughout the products life cycle



Qualification / Background:
Preferably PhD degree, or equivalent
Approximately 5 years of documented relevant experience, preferably in conducting Clinical Evaluations
Documented experience in scientific writing, literature search strategies and analysis
Thorough understanding of applicable regulations and guidelines such as MDR and MEDDEV 2.7.1.
Understanding of medical device development and product life cycle requirements
Clinical experience, preferably within Urology a/o Enterology, is an advantage
Proficient in English (verbal and writing)


We believe that you are a positive and driven person with the ability to extract, assess and communicate, relevant information from various sources such as scientific publications, reports and post market surveillance data. You are excellent in writing regulatory documentation! You are used to independently dig deep into extensive data sources, yet with an appropriate sense of urgency. Strong stakeholder management is key as your success is partly based on your cross functional interactions. You challenge and explore status quo with a clear ambition of constantly improving our way of working.
We are interviewing candidates continuously, so to enhance your chances, we recommend that you send us your application as soon as possible.
We look forward to hearing from You.