"Regulatory Affairs Officer Job in Ahmedabad | Advin Health Care Hiring Freshers | Pharma Duniya"

(Regulatory Affairs Officer Job in Ahmedabad)

Introduction

If you are a fresher or early-career professional looking to start a long-term career in Medical Device Regulatory Affairs, then this opportunity can be a strong foundation for your future.
Advin Health Care, a growing name in the medical device manufacturing sector, has opened recruitment for the post of Regulatory Affairs Officer at its Ahmedabad facility.

This role is especially suitable for freshers (0–1 year experience) who want hands-on exposure to CDSCO submissions, Medical Device Rules (MDR), 2017, ISO 13485 Quality Management System, and global regulatory frameworks such as US FDA and EU MDR.

About The Company – Advin Health Care

Advin Health Care is an Indian medical device manufacturing and regulatory-driven organization focused on delivering high-quality, compliant, and innovative medical devices for domestic and international markets.

• Company Name: Advin Health Care

• Headquarters: Ahmedabad, Gujarat, India

• Industry: Medical Devices & Healthcare Manufacturing

• Nature: Private Organization

• Established: As per available information, the company has been operational for several years in the medical device sector.r

• Employees: Approx. 50–200 professionals (manufacturing, QA, RA & operations)

Advin Health Care actively follows CDSCO Medical Device Rules, ISO 13485 standards, and international regulatory guidelines, making it an ideal workplace for candidates aiming to grow in Regulatory Affairs & Quality Compliance.

Job Overview Summary

The Regulatory Affairs Officer role at Advin Health Care is designed for candidates who want practical regulatory exposure rather than just theoretical knowledge.

Selected candidates will work closely with Regulatory Affairs, Quality Assurance, and cross-functional teams, supporting CDSCO medical device submissions, ISO documentation, and international regulatory registrations. This position provides a clear learning curve toward becoming a Regulatory Affairs Specialist for Class II & Class III Medical Devices.

Vacancy Details (Official)

• Company Name: Advin Health Care

• Job Title: Regulatory Affairs Officer

• Department: Regulatory Affairs

• Job Type: Full-time

• Experience Required: 0–1 Year

• Job Location: Ahmedabad, Gujarat

• Industry: Medical Devices / Healthcare

Key Responsibilities – Explained

As a Regulatory Affairs Officer, your day-to-day responsibilities will include:

• Supporting CDSCO medical device submissions as per Medical Device Rules (MDR), 2017

• Preparing and reviewing regulatory dossiers, applications, and supporting documents

• Assisting in ISO 13485 certification, audits, and documentation maintenance

• Coordinating with QA teams for compliance and corrective actions

• Supporting MDSAP and international regulatory submissions

• Understanding regulatory guidelines and ensuring accurate execution of assigned tasks

• Maintaining regulatory records, logs, and compliance documents

• Gaining real-time exposure to regulatory compliance in a manufacturing environment

Eligibility Criteria (Official)

Candidates must possess a Bachelor’s Degree in any of the following disciplines:

• Engineering

• Life Sciences

• Biomedical Engineering

• Mechanical Engineering

• Polymer Science

• Pharmacy

Experience:

• 0–1 year

• Freshers are encouraged to apply

Preferred (Not Mandatory):

• Internship or academic project exposure in Regulatory Affairs / Quality Assurance

Skills Required 

To perform well in this role, candidates should have:

• Basic awareness of CDSCO Medical Device Rules, 2017

• Understanding of ISO 13485 Quality Management System

• Introductory knowledge of US FDA & EU MDR (added advantage)

• Good documentation and analytical skills

• Ability to understand compliance requirements

• Willingness to learn and take responsibility

• Clear communication and a teamwork mindset

Salary Estimate

💰 Estimated CTC:
₹2.5 LPA – ₹4.0 LPA

Salary may vary based on:

• Educational background

• Regulatory knowledge

• Internship or practical exposure

• Interview performance

Interview Details (Official)

• Interview Mode: To be informed by the company (Online / In-person)

• Interview Date: Not disclosed

• Selection Process:

  • Resume Shortlisting

  • Technical & HR Interview

Shortlisted candidates will be contacted directly by the company.

Required Documents 

Candidates should keep the following documents ready:

• Updated Resume / CV

• Educational Certificates & Mark Sheets

• ID Proof (Aadhar / PAN)

• Internship Certificate (if applicable)

• Passport-size Photograph

Job Location

📍 Advin Health Care
Aarna Fortune, B/H Chittvan
South Bopal, Ahmedabad
Gujarat – India

Apply Method

Interested and eligible candidates can apply through:

• Official company communication channels

• Job portals / HR email (as shared by the recruiter)
  

• regulatory@advinhealthcare.com

👉 Always ensure you apply using official and verified sources only.

FAQs – Regulatory Affairs Officer Job

Q1. Is this job suitable for freshers?
Yes, freshers with a relevant educational background can apply.

Q2. Is experience mandatory?
No. Candidates with 0–1 year of experience are eligible.

Q3. Does this role provide CDSCO exposure?
Yes, candidates will work on CDSCO submissions as per MDR 2017.

Q4. Is ISO 13485 experience provided?
Yes, hands-on exposure to ISO 13485 documentation and compliance.

Q5. Is this a medical device regulatory role?
Yes, this role is strictly focused on medical device regulatory affairs.

Final Conclusion

The Regulatory Affairs Officer vacancy at Advin Health Care, Ahmedabad, is an excellent opportunity for freshers who want to build a strong and stable career in medical device regulatory affairs. With exposure to CDSCO, ISO 13485, and global regulatory systems, this role provides the right platform to grow toward Regulatory Specialist positions in the future.

If you are serious about entering the medical device regulatory domain, this job can be your first strong step.

Disclaimer

Note: Pharma Duniya does not charge any money for job information.
Candidates are advised to verify details from the official company website.

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