Experience Level

Entry & Mid-Level

Mid-Level: 2-5 years of experience
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
• Individual contributor with minimal supervision
• 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

Regulatory Affairs – Associate
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

Experience with any medical device industry or service is MUST
Experience in regulatory affairs and good technical documentation skills
Regulatory compliance knowledge towards EU MDR, and USFDA is required
Exposure/experience in any of the post-market plans, Clinical Evaluation procedures, risk management, and labelling are a plus
Knowledge on ISO 13485, ISO 14971, MEDDEV 2.7/1 Rev. 4, and IEC standards are preferred
Knowledge on Medical Device Regulations for different global markets
Experience with FDA submission is a plus
Ability to self-learn and adapt to the dynamic regulatory environment

You will be part of a rapidly growing organization, with an opportunity to work alongside the best minds in the industry. Competitive compensation and rewards, an opportunity to grow with a young company.
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