Medical Regulatory Affairs Specialist
As a Regulatory Affairs Specialist, you will play a pivotal role in bringing our medical devices to market and keeping them compliant across the globe, with a strong emphasis on the EU. You’ll be the go-to expert for regulatory matters — driving submissions, coordinating compliance activities, and partnering with internal teams, external stakeholders, and regulatory agencies to ensure smooth, timely approvals. From maintaining meticulous technical documentation to tracking evolving regulations, you’ll be at the forefront of safeguarding product quality, enabling innovation, and supporting our mission to improve patient outcomes worldwide
What you will do
- Develop and maintain technical product documentation and premarket submissions for CE-marked, FDA-cleared, and custom-made devices; coordinate with internal teams to meet submission deadlines
- Monitor and interpret European and national medical device regulations and standards, providing guidance to support business operations
- Serve as the interface with regulatory agencies, such as the FDA, notified bodies, and competent authorities, during technical file review or audits, and ensure timely responses to any inquiries
- Approve and review labeling and marketing materials for devices within your portfolio
- Support the enhancement of internal systems and workflows, ensuring alignment with applicable regulations like CE marking and MDSAP
Your profile
- Master’s degree in a relevant scientific discipline (e.g., engineering, pharmacy, bio‐medical sciences)
- At least 3 years of regulatory or equivalent experience in the medical device industry
- Strong knowledge of European medical device regulations and experience developing and maintaining product registration files and technical documentation
- Strong technical writing and communication skills in English.
- Proficient in MS Office (Word, Excel, PowerPoint)
- Organized, pragmatic, hands-on, and flexible
- Able to manage multiple priorities and projects in a global context
What we offer
Healthy life-work balance
When creating a better and healthier world, a good place to start is with yourself. That's why we encourage our employees to prioritize their overall well-being, fostering physical fitness, mental resilience, and social connections through a range of workshops, sports activities, and other events and initiatives that contribute to a balanced and fulfilling work-life harmony.
Hybrid working & flexibility
At Materialise, we value the power of in-person connections and the advantages of remote work, allowing our employees the flexibility to enjoy the best of both worlds. You can work remotely up to 60% of the time and work flexible hours, depending on your particular role.
Personal growth and career advancement
At Materialise, we’re committed to nurturing the professional development of our employees. We invest in our passionate people and empower them to explore and grow by offering diverse career paths that capitalize on their talents. Plus, we offer courses, external coaching programs, and in-house mentoring so that our employees can fulfill their potential.
Team building
We cultivate a positive work culture so our employees have an enjoyable professional environment. Collaboration is key, so we organize activities that unite our employees, such as after-work events and team lunches. We want all our staff to feel connected in an environment that promotes strong bonds based on trust, respect, empathy, and friendship.
Innovation is key
Innovation is not just a buzzword at Materialise; it's at the core of what we do. As pioneers in our industry, we create cutting-edge solutions, fostering an environment that supports and rewards ingenuity and leadership. We’re dedicated to shaping the future of 3D printing, recognizing and celebrating the creative spirit within all our global innovators.
Healthy life-work balance
When creating a better and healthier world, a good place to start is with yourself. That's why we encourage our employees to prioritize their overall well-being, fostering physical fitness, mental resilience, and social connections through a range of workshops, sports activities, and other events and initiatives that contribute to a balanced and fulfilling work-life harmony.
Hybrid working & flexibility
At Materialise, we value the power of in-person connections and the advantages of remote work, allowing our employees the flexibility to enjoy the best of both worlds. You can work remotely up to 60% of the time and work flexible hours, depending on your particular role.
Personal growth and career advancement
At Materialise, we’re committed to nurturing the professional development of our employees. We invest in our passionate people and empower them to explore and grow by offering diverse career paths that capitalize on their talents. Plus, we offer courses, external coaching programs, and in-house mentoring so that our employees can fulfill their potential.
Team building
We cultivate a positive work culture so our employees have an enjoyable professional environment. Collaboration is key, so we organize activities that unite our employees, such as after-work events and team lunches. We want all our staff to feel connected in an environment that promotes strong bonds based on trust, respect, empathy, and friendship.
Innovation is key
Innovation is not just a buzzword at Materialise; it's at the core of what we do. As pioneers in our industry, we create cutting-edge solutions, fostering an environment that supports and rewards ingenuity and leadership. We’re dedicated to shaping the future of 3D printing, recognizing and celebrating the creative spirit within all our global innovators.
Location and type of contract
- Leuven, Belgium
- Full-time
- Hybrid
- Associate level
- CV in English
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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.