Company Description

Endimension Technology is a HealthTech company founded by IIT alumni, developing AI-powered Software as a Medical Device (SaMD) solution. With a growing international presence, we aim to address the shortage of radiologists and improve patient care through our innovative AI solutions. Join our team to work on meaningful healthcare challenges and be part of a growing, collaborative and innovative environment.

Role Overview

This is a full-time, on-site role for a Regulatory Affairs Specialist located in Mumbai. We are looking for a sincere, disciplined and confident communicator to manage regulatory documentation, quality management system (QMS) activities and medical device registration processes across domestic and international markets. Following are some of the key roles and responsibilities.

- Prepare and maintain medical device technical files and regulatory dossiers for SaMD.
- Manage regulatory submissions, manufacturing licences and product approvals across domestic and international markets.
- Prepare and maintain ISO 13485 QMS documentation and support audit readiness.
- Develop IFUs, product labelling, Clinical Evaluation Reports (CERs), and risk management documentation.
- Manage Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities, as applicable.
- Indian Medical Device Rules, 2017 & EU MDR 2017/745 knowledge
- Respond to regulatory queries and liaise with regulatory authorities and Ministries of Health.
- Maintain regulatory records and coordinate with cross-functional teams to ensure compliance.

Qualifications

- Bachelor's or Master's degree in a relevant field - B.sc / M.sc / B.Pharm/ M.Pharm /Bachelor Or Master Degree In Bio-Medical Engineering / Science Discipline With Training In Medical Devices In Regulatory Affairs




- Strong knowledge and experience in regulatory documentation, compliance and requirements
- Strong attention to detail and analytical skills
- Excellent communication and documentation skills
- Ability to effectively communicate and collaborate with cross-functional teams
- Experience in the healthcare or medical device industry is preferred
- Knowledge Of USFDA 510K or CE is a bonus.

Benefits:

- Competitive salary and benefits package with yearly bonus
- Medical Insurance for Self and dependants.
- Provident Fund
- A culture focused on talent development and growth.
- Chance to work with cutting-edge technologies.

Job Type: Full-time
Benefits:

- Health insurance
- Provident Fund

Schedule:

- Fixed shift

Ability to commute/relocate:

- Ghansoli, Navi Mumbai : Reliably commute or planning to relocate before starting work (Preferred)

Experience:

- Total work: 1-2 years (Required)

Work Location: In person

Pay: ₹300,000.00 - ₹400,000.00 per year

Application Question(s):

- 1. Tell us about yourself and your background in 4–5 lines.
- 2. College Name, Degree, CGPA / Percentage.
- 3. Have you completed any certifications or training courses in Regulatory Affairs?
- 4. Do you have experience in the HealthTech or MedTech industry? If yes, briefly describe your role and responsibilities?
- 5. Do you have hands-on experience preparing or maintaining ISO 13485 QMS documentation?
- 6. Do you have experience with Software as a Medical Device (SaMD)?
- 7. Are you familiar with EU MDR 2017/745 and the Indian Medical Device Rules, 2017?
- 8. Do you have hands-on experience with CDSCO medical device licensing, registration, or regulatory submissions? If yes, briefly describe your experience.
- 9. What is your current annual CTC?
- 10. What is your expected annual CTC?

Work Location: In person

📌 Regulatory Affairs Specialist (Ghansoli)
🏢 ENDIMENSION TECHNOLOGY
📍 Ghansoli