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Romsons Recruitment 2026 | Executive Regulatory Documentation Jobs in Gujarat | Apply Now

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Romsons is hiring Executive – Regulatory Documentation professionals for its Sanand Plant, Gujarat. Candidates with 2–5 years of experience in CE Technical Documentation, EU MDR, and ISO 13485 can apply now.

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Romsons Recruitment 2026

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Romsons Recruitment 2026: Executive – Regulatory Documentation Jobs at Sanand Plant, Gujarat 🚀

The Indian medical device industry continues to grow rapidly as manufacturers expand their presence in global healthcare markets. With increasing exports and stricter international quality regulations, companies are actively seeking skilled regulatory professionals who can ensure products comply with global standards.

If you have experience in regulatory affairs, CE technical documentation, and European medical device regulations, this could be an excellent opportunity to advance your career.

Romsons, one of India’s well-known medical device manufacturers, is currently recruiting for the position of Executive – Regulatory Documentation at its Sanand Manufacturing Plant, Gujarat. The selected professional will play an important role in managing documentation required for CE certification and maintaining compliance with European Union Medical Device Regulation (EU MDR).

This position offers exposure to international regulatory standards, cross-functional collaboration, and opportunities to contribute to global medical device projects.

About Romsons

Romsons is recognized for manufacturing a wide range of medical devices used by hospitals and healthcare professionals. The company focuses on quality, innovation, and regulatory compliance while supplying products to domestic and international markets.

Working with Romsons allows professionals to gain valuable experience in documentation, quality systems, and international regulatory affairs.

Job Overview

Particular	Details
Company	Romsons
Position	Executive – Regulatory Documentation
Department	Regulatory Affairs
Location	Sanand Plant, Gujarat
Industry	Medical Devices
Experience	2–5 Years
Employment Type	Full-Time

Key Responsibilities

The selected candidate will be responsible for supporting regulatory compliance activities and maintaining documentation required for medical device approvals.

Major responsibilities include:

Preparing and maintaining CE Technical Documentation.
Ensuring compliance with EU MDR (2017/745).
Updating Risk Management Files.
Preparing Clinical Evaluation Reports (CER).
Managing Instructions for Use (IFU) documentation.
Reviewing product labels and artwork.
Supporting internal and external regulatory audits.
Maintaining document control according to ISO 13485.
Coordinating with Quality Assurance, Manufacturing, R&D, and Regulatory teams.
Tracking documentation timelines for product submissions.
Reviewing technical files for completeness and accuracy.
Supporting CE certification activities.

Educational Qualification

Candidates should possess any of the following qualifications:

B.Tech / B.E. (Biomedical Engineering)
B.Pharm
M.Pharm
B.Sc. Life Sciences
M.Sc. Biotechnology
Other relevant science or engineering disciplines

Experience Required

Applicants should have:

2–5 years of relevant experience.
Experience in Medical Device Regulatory Affairs.
Hands-on exposure to CE Technical Documentation.
Knowledge of EU MDR 2017/745.
Understanding of ISO 13485 Quality Management System.
Experience supporting regulatory audits is preferred.

Preferred Skills

Successful candidates should possess:

Strong technical writing skills
Excellent documentation practices
Attention to detail
Knowledge of regulatory submission processes
Good communication skills
Time management abilities
Team collaboration skills
Problem-solving mindset

Why Join Romsons?

Working at Romsons offers several professional advantages:

International Regulatory Exposure

Gain practical experience with global medical device regulations and CE certification.

Career Growth

Develop expertise in regulatory affairs, quality systems, and compliance management.

Advanced Manufacturing Environment

Work in a modern manufacturing facility following international quality standards.

Collaborative Work Culture

Coordinate with multidisciplinary teams across engineering, quality, production, and regulatory departments.

Why CE Documentation Experience Matters

Medical devices sold in European countries must comply with stringent regulatory requirements. Proper documentation is essential for product approval, market access, and patient safety.

Professionals experienced in CE Technical Documentation become valuable assets because they help organizations:

Meet global compliance standards
Reduce regulatory risks
Support successful audits
Maintain product approvals
Facilitate international business expansion

How to Apply

Interested candidates who meet the eligibility criteria can apply using the details below.

Email Your Resume

📧 hr.rg3@romsons.com

Suggested Subject Line:

Application for Executive – Regulatory Documentation – Sanand

HR Contact Number

📞 9289891771

Important Tips Before Applying

Update your resume with relevant regulatory projects.
Mention experience in CE Technical Documentation.
Highlight knowledge of EU MDR and ISO 13485.
Include audit experience if applicable.
Proofread your CV before sending.

Frequently Asked Questions (FAQs)

What position is Romsons hiring for?

Executive – Regulatory Documentation.

Where is the job located?

Sanand Plant, Gujarat.

What experience is required?

Candidates should have 2–5 years of experience in Medical Device Regulatory Affairs or Technical Documentation.

Which regulations should applicants know?

Knowledge of EU MDR 2017/745 and ISO 13485 is preferred.

Is CE Technical Documentation experience mandatory?

Yes. Candidates with hands-on CE documentation experience will be preferred.

How can I apply?

Interested candidates can send their updated CV to hr.rg3@romsons.com.

Final Thoughts

Professionals with expertise in regulatory affairs and medical device documentation are increasingly in demand as manufacturers expand globally. This opening at Romsons provides an opportunity to work on international compliance projects while building valuable experience in CE certification and EU MDR documentation.

If your experience aligns with the role, consider applying promptly with an updated resume highlighting your regulatory documentation expertise.

Romsons Recruitment 2026: Executive – Regulatory Documentation Jobs at Sanand Plant, Gujarat | Apply Now