Clinical Affairs Specialist
Apply to this jobThe Position
Materialise is a dynamic, high-tech company headquartered in Belgium, with offices worldwide. Founded in 1990, today we have over 2,300 employees around the globe. Materialise’s mission is to innovate for a better and healthier world through our software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). To achieve this goal, we collaborate with businesses in diverse industries such as automotive, aerospace, healthcare, research, and academia.
As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.
Qualifications & Experience
Responsibilities
- Within our Clinical Affairs team, you take responsibility for projects involving the gathering and structuring of clinical evidence and with a global focus. This includes:
- Defining the clinical strategy for our medical devices, and documenting Clinical Evaluation plans and reports
- Creating and maintaining up to date of Post-Market Surveillance Plans and Reports
- Performing systematic literature search to analyze the available clinical literature for a variety of medical devices
- You plan, implement, and execute the operational side of clinical investigations, communicating with your Clinical Affairs and Regulatory Affairs colleagues, and collaborating closely with product and market managers.
- You interact with all required external parties (hospitals, surgeons, authorities) involved in the projects and studies
- You interact with internal parties (Risk management, R&D, Regulatory Affairs, Marketing, Product Management, Quality Management) to close the loop with clinical evaluation and post-market surveillance and drive action and improvement where needed
- You write and review documentation in line with applicable requirements, such as EU Medical Device Regulation (EU MDR). You follow-up on industry trends and developments to continually update the clinical evaluation plans, and our governing procedures
Requirements
- You have an academic degree in (life) sciences
- Ideally you have at least several years of previous professional experience in a regulated environment such as medical device industry in Regulatory Affairs, Quality or Clinical Affairs
- Ideally you have a comprehensive knowledge of European Clinical Evaluation guidelines and regulations (MEDDEV 2.7/1 Rev.4, EU MDR, MDCG guidelines)
- You have sound experience in scientific/medical writing demonstrated by authorship of scientific publications, or through similar professional experience
- You have excellent communication skills; full professional proficiency in English is required
- You have a pro-active mindset. You are a convincing communicator and are not afraid to suggest improvement possibilities
Interested? Send your resume and a short introduction of yourself to the email address behind the 'apply now' button!
We offer an inspiring and challenging job with growth potential in an innovative market. You will be part of a dedicated team within a dynamic company that highly values openness, trust and team spirit.
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Having a healthy work-life balance
When creating a better and healthier world, a good place to start is with yourself. That’s why we encourage our employees to stay fit both physically and mentally by offering sports workshops and flexible hours with the possibility of working remotely.
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Personal growth and career opportunities
Materialise invests in people and want to see them grow in a career that fits them best. We offer personal training to every employee, so they can access every available career opportunity.
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Team building
It’s also important to enjoy working at Materialise. With initiatives such as memorable team building activities, lively after-work drinks and team lunches, we’re building a work environment in which our employees feel good.
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Innovation is key
Innovation isn’t an empty word at Materialise. We create and deliver high-tech solutions in additive manufacturing. Innovation and leadership by our employees is both encouraged and rewarded.