Regulatory Affairs Specialist
The Regulatory Affairs Specialist is responsible for a range of regulatory activities and will be involved in several regulatory operations projects. Acting as an expert, you contribute to shaping the regulatory landscape and concepts of Materialise’s worldwide presence. This includes regulations of the EU and MDSAP jurisdictions and selected other markets.
What you will do
- Be responsible for translating regulatory requirements in the field of quality management, conformity assessments and registrations, post-market surveillance, vigilance, and clinical evaluation/investigation into efficient processes
- Have a generalist approach when it comes to regulatory operations projects
- Work to meet the regulatory requirements to do business based on a list of priorities agreed upon with the business unit: analyzing the applicable regulations, defining product registration strategies, and working together with a wide range of teams to generate and review product documentation to ensure timely market access for our medical solutions
- Be accountable for the completeness and quality of our conversion engineer technical files and submissions, coordinating between the various departments involved in writing the documentation
- Be willing to grow into a professional track, possibly specializing in specific product/market expertise
- Master level in a medical, engineering, or regulatory field
- A minimum of 3 years experience in regulatory affairs in the medical industry
- You possess practical knowledge of at least one of the regulatory frameworks mentioned above
- You have a track record of implementing regulations into workable and efficient processes
- You master good organizational skills with a pragmatic, hands-on, and flexible approach to your work
- You are able to keep a high-level overview of ongoing priorities and can easily coordinate multiple projects
- You are responsible for following up with internal/external stakeholders and are used to working within an international team across various time zones
- You are a good communicator, both within the company and towards relevant authorities
- Good written and verbal skills in English are a must
Location and type of contract
- Petaling Jaya, Malaysia
- Mid-senior level
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.