Romsons Hiring 2026 | Executive – Regulatory Documentation Jobs in Gujarat (Medical Devices | CE Certification)

Romsons Hiring 2026 – Regulatory Documentation Executive

Romsons, a well-known name in the medical device industry, is inviting applications for the role of Executive – Regulatory Documentation at its Sanand Plant in Gujarat. This is a great opportunity for professionals looking to build a career in CE certification and global regulatory compliance.

If you have experience in medical device documentation and regulatory standards, this role offers a strong platform for career growth.

Job Location

  • Sanand Plant, Gujarat

Job Role

  • Position: Executive – Regulatory Documentation
  • Industry: Medical Devices
  • Focus Area: CE Certification (EU MDR Compliance)

Qualifications Required

  • Bachelor’s Degree in:
    • Biomedical Engineering
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Or related field

Experience Required

  • 2 to 5 Years in:
    • Medical Device Regulatory Affairs
    • Documentation & CE Technical Files

Key Responsibilities

  • Prepare and maintain CE technical documentation
  • Ensure compliance with EU MDR regulations
  • Manage technical files, risk assessments, and clinical reports
  • Coordinate with R&D, QA, Production, and Regulatory teams
  • Support internal and external audits
  • Track documentation timelines and ensure timely submission
  • Maintain document control as per ISO 13485

Skills Required

  • Strong knowledge of CE documentation
  • Understanding of medical device regulations
  • Excellent technical writing skills
  • Good communication and coordination abilities
  • Strong attention to detail and compliance

Why Join Romsons?

  • Work on global CE certification projects
  • Be part of a growing medical device company
  • Opportunity to contribute to international compliance
  • Professional and collaborative work environment
  • Career growth in regulatory affairs

How to Apply

FAQs (SEO Boost Section)

Q1. What is the role offered by Romsons?

Executive – Regulatory Documentation in the medical device sector.

Q2. What experience is required?

Candidates with 2–5 years of experience in regulatory affairs and CE documentation.

Q3. What is CE Certification?

CE Certification ensures that products meet EU safety, health, and environmental protection standards.

Q4. Where is the job location?

Sanand Plant, Gujarat.

Q5. Who can apply?

Candidates with degrees in Biomedical, Pharmacy, Life Sciences, or related fields.

Romsons Hiring 2026

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