Amanta Healthcare Ltd. is inviting applications for the position of Sr. Executive/Executive – Regulatory Affairs (Medical Devices – Ocular) at its Kheda, Gujarat facility. This is an excellent opportunity for experienced B.Pharm/M.Pharm professionals looking to build a rewarding career in Regulatory Affairs Medical Device jobs with a globally recognized pharmaceutical and healthcare company.
Candidates having 4–6 years of experience in medical device regulatory affairs, international registrations, EU-MDR compliance, CE certification, and global regulatory submissions are encouraged to apply.
Job Details
| Particular | Details |
|---|---|
| Company | Amanta Healthcare Ltd. |
| Job Role | Sr. Executive / Executive – Regulatory Affairs (Medical Devices – Ocular) |
| Location | Kheda, Gujarat |
| Vacancies | 01 |
| Qualification | B.Pharm / M.Pharm or relevant qualification |
| Experience | 4–6 Years |
| Industry | Medical Devices / Regulatory Affairs |
| Salary | Negotiable (Approx. ₹7.5–10.5 LPA) |
Key Responsibilities
The selected candidate will be responsible for:
- Managing regulatory affairs activities for ocular medical devices.
- Preparing, reviewing, and maintaining Technical Dossiers, Technical Files, EC Documentation, Technical Data Sheets, and Risk Management files.
- Handling international product registrations and regulatory submissions.
- Managing country-specific registration processes for global markets.
- Reviewing and approving artwork for medical devices.
- Coordinating regulatory compliance throughout the product lifecycle.
- Ensuring compliance with international medical device regulations and quality systems.
Required Skills & Expertise
Applicants should possess strong knowledge and hands-on experience in:
- EU-MDR (European Medical Device Regulation)
- CE Certification
- ISO 13485
- MDSAP
- UKCA
- IMDR 2017
- International regulatory registrations
- Technical Documentation preparation
- Risk Management documentation
- Artwork review and approval
- Medical Device Compliance
Global Market Exposure Required
Experience in regulatory submissions and certifications for the following regions is highly preferred:
- European Union (EU)
- Great Britain (UKCA)
- Canada
- United States (FDA)
- Australia
- Brazil
- Japan
- LATAM
- MENA
- Asia-Pacific
- South Africa
Candidates with experience in Class IIa and Class IIb Medical Devices will be given preference.
Eligibility Criteria
Candidates should have:
- B.Pharm, M.Pharm, or equivalent qualification.
- 4–6 years of Regulatory Affairs experience in Medical Devices.
- Strong documentation and communication skills.
- Experience with international regulatory agencies and certification bodies.
Employee Benefits
- Competitive salary package
- Opportunity to work on global regulatory projects
- Exposure to international medical device markets
- Career growth with a reputed healthcare organization
- Bus transportation available across Ahmedabad, Kheda, Nadiad, and Anand
How to Apply
Interested and eligible candidates can send their updated CV to:
Email: sumit_dwivedi@amanta.co.in