Regulatory Affairs jobs in Malaysia

Mid-senior level Petaling Jaya, Malaysia Hybrid Full-time Engineering

As a Medical Regulatory Affairs professional, 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.

• 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.
• Translate 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.

• 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.
• Track record in implementing regulations into workable and efficient processes.
• Good organizational skills with a pragmatic, hands-on, and flexible approach to work.
• Ability to keep a high-level overview of ongoing priorities and coordinate multiple projects.
• Responsible for following up with internal/external stakeholders and flexible to work within an international environment with team members located in multiple time zones.
• Good communicator, both within the company and towards relevant authorities.
• Good written and verbal skills in English are a must.

• Petaling Jaya, Malaysia
• Full-time
• Hybrid
• Mid-senior