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Intern Role – Regulatory Affairs

Opportunities for budding young engineering talents to join the industry

Experience Level

Entry level : Graduate to 1 year

In this role, you will be expected to have the following attributes:
• Work on deadlines
• Highly professional
• Excellent Microsoft Outlook, Excel, Word, and PPT skills
• Basic knowledge of medical devices
• English speaking, writing, and listening skills are highly desired
• Attention to details
• Enthusiasm to learn more and grow rapidly
• Highly confident and self-motivated
• Optimistic and problem-solving thought process

Educational Background

• B.E/B. Tech Degree in Biomedical Engineering / Medical Electronics / Medical Instrumentation /equivalent domain
• Good academic Record of >70% in High school and a Degree

𝐉𝐨𝐛 𝐑𝐨𝐥𝐞

Internship (6 months & confirmation based on the performance)
Nature: Full-time – Remote Based

Responsibilities

Helping families live intelligently means we’re always working to bring our customers the latest technology. As one of the premier providers of smart home technology, we are recognized throughout the industry for our products, innovation & customer satisfaction. Don’t worry about any thing, our security experts will install your new system, activate it.
Manage country registrations (EU, Swiss, global)
Prepare technical documentation for regulatory compliance (EU MDR, 510(K), UKCA)
Works in close collaboration with external stakeholders and is able to support and manage multiple projects at a time.
Ability to manage deliverables in a dynamic environment in a timely manner
Ensures compliance with global regulatory requirements and adherence towards internal policies and processes
Provides high-quality regulatory support for assigned products/projects
Ability to work with cross-functional project members and respond to regulatory queries

𝐓𝐨𝐩 𝐒𝐤𝐢𝐥𝐥 𝐒𝐞𝐭𝐬

Strong fundamental knowledge about medical device(s)
High learning attitude
Proactive and take initiative at work
Basic knowledge about Ethical behaviour at work
Basic Knowledge on ISO 13485, and ISO 14971 is desired
Basic Knowledge on Medical Device Regulations (minimum EU, FDA)