Regulatory Affairs Specialist
Do you have a passion for regulatory affairs? Do you love working with a broad range of innovative medical devices? Do you like defining the optimal strategy to obtain or maintain marketing authorization for these devices? Are you a good communicator and do you feel at home in an international multicultural environment? Then it is you that we are looking for to complete our team as a Regulatory Affairs Specialist!
What you will do
- You prepare and submit product technical documentation or premarket submissions to obtain or to maintain market authorization for our CE marked, FDA-cleared, and custom-made medical devices. You communicate clearly with internal teams and stakeholders about these submissions and ensure that agreed timelines are respected.
- You interface with regulatory agencies, such as the FDA, Notified Bodies, and Competent Authorities, and respond to their questions within strict timelines.
- You guide and review development and engineering activities to assure regulatory compliance during new product development and product changes. You create and maintain the technical documentation of these products.
- You review and approve labeling and marketing material of the medical devices within your portfolio.
- You interpret and monitor regulations, guidances, and standards and translate them into efficient internal procedures and processes.
- Master degree in a relevant scientific discipline (including engineer, pharma, biomedical sciences, law)
- Minimum of 3 years of regulatory or equivalent experience within the medical device industry
- Experience with the interpretation and application of ISO 13485, Quality System Regulations, Medical Device Directive, and Medical Device Regulation
- Preferably familiar with medical device (hardware and software) development, risk management, labeling requirements, or clinical evaluation
- Experience in implementing regulations into workable and efficient processes
- Excellent technical written and communication skills in English are a must, knowledge of Dutch is an asset
- Good organizational skills with a pragmatic, hands-on, and flexible approach to your work
- Able to keep a high level overview of ongoing priorities and can easily coordinate multiple projects within a global context.
- Must be proficient in MS Office products, including Word, Excel, and PowerPoint
Location and type of contract
Working at Materialise
Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, 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.