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.

Your profile

  • 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

  • Belgium
  • Full-time

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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.

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Benefits

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.

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.

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.

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.