Medical Regulatory Affairs
You will be 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.
What you will do
- Determine and analyze local registration and other regulatory requirements of the countries to which the business unit wants to bring its medical devices; your main focus will be on the APAC and Middle East regions
- Define product registration strategies and work together with multiple internal teams to generate and review product documentation and supporting documents to ensure timely market access for our medical solutions
- Track the progress of regulatory documentation submissions and/or registration applications within regulatory agencies
- Monitor the regulatory status of registered products for registration renewals; inform product or market management in a timely manner to ensure uninterrupted compliance and market access
- Be responsible for translating regulatory requirements of assigned countries into efficient internal processes; continuously monitor and evaluate the regulatory climate of these countries and assess any changes that may arise
Your profile
- Bachelor’s degree in a scientific, medical, engineering, or regulatory field.
- A minimum of 5 years of experience in regulatory affairs in the medical industry (experience with medical devices is a plus), with experience handling registration outside of Malaysia
- You have a track record in 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 flexible to work within an international environment with team members located in multiple time zones
- You are a good communicator, 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
- Full-time
- Hybrid
- Mid-senior
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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.
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.
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.
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.
