We are inviting applications for Associate Role – Regulatory Affairs
No. of positions: 05
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
𝐉𝐨𝐛 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬:
- 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.
Intern – Regulatory Affairs
Opportunities for budding young engineering talents to join the industry
We are inviting applications for Intern – Regulatory Affairs
No. of positions: 06
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
𝐉𝐨𝐛 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬:
- 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)