
Regulatory Affairs Development Role
8 hours ago
This role offers the opportunity to work in a regulated medical device company and develop knowledge of quality, regulatory, and legal frameworks.
You will be able to apply basic knowledge of quality, regulatory, and legal processes, procedures, EU Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745, and US regulatory requirements across a wide range and classification of products.
It allows you to see how these regulations are implemented in industry practice.
Key Responsibilities:- Collaborate with your team leader and supervisor to identify a Quality/Regulatory Affairs improvement project, including objectives, scope, milestones, and evaluation.
- Communicate project updates and present at review forums.
- Assist in developing regulatory procedures and best practices.
- Help prepare technical documentation and submission packages for regulatory agencies.
- Evaluate and maintain compliance with quality and safety systems.
Develop skills to adapt to the workplace by being dependable, punctual, hardworking, organized, and a team player with initiative.
Requirements:- Currently completing a university qualification in Engineering, Science, or related courses.
- Honesty and integrity; compliance with quality systems, regulations, and policies.
- Self-motivated, flexible, and hardworking; enjoy working in a dynamic, results-oriented environment.
- Reliable, dependable, and punctual.
- Organized, focused, and capable of multi-tasking.
- Good analytical and problem-solving skills.
- Good verbal and written communication skills and basic PC skills.
A team player capable of working in a multi-disciplinary team. Available for 6, 9, or 12 months, with exact duration and start date to be discussed.
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