Amanta Healthcare Hiring Sr. Officer in Regulatory Affairs

Sr. Officer Regulatory Affairs (B.Pharm/M.Pharm) Kheda

Amanta Healthcare seeks B.Pharm/M.Pharm Sr. Officer in Regulatory Affairs (Medical Devices, Ocular). 0–4 yrs experience. Kheda. Apply now.

Amanta Healthcare is hiring a Sr. Officer / Executive for Regulatory Affairs focused on ocular medical devices at its Kheda facility. This role suits early-career regulatory professionals who want hands-on responsibility for international registrations, technical dossier preparation, and ongoing compliance with global standards such as EU‑MDR, ISO 13485, and MDSAP. The position offers exposure to multi‑market regulatory strategy, artwork and labeling approval, and lifecycle management of Class II/III devices — a strong step for anyone building a career in medical device regulation.

Company Overview

Amanta Healthcare Ltd. is a growing medical device and healthcare products company with a focus on high-quality ocular and specialty devices. The company emphasizes regulatory excellence, quality systems, and global market access. With manufacturing and commercial operations serving regional and international markets, Amanta invests in certification, compliance, and product safety to ensure patient well‑being. The Kheda site supports regulatory, quality, and supply chain activities, and offers bus facilities covering Ahmedabad, Kheda, Nadiad, and Anand for convenience.

Job Role & Responsibilities

The Sr. Officer / Executive — Regulatory Affairs (Medical Devices — Ocular) will lead and support regulatory activities across the device lifecycle. Primary responsibilities include:

• Prepare, review and manage Technical Dossiers / Technical Files and EC Documentation for Class II and Class III ocular devices.
• Drive EU‑MDR compliance activities, including gap assessments, documentation updates, and post‑market surveillance inputs.
• Lead CE marking and UKCA strategies; coordinate with Notified Bodies and external consultants for audit readiness.
• Maintain and expand ISO 13485 and MDSAP compliance; support internal and external audits and remedial actions.
• Manage international registrations across EU, LATAM, MENA, Africa, Asia‑Pacific, Great Britain and Australia — prepare country‑specific submission packages and respond to regulatory queries.
• Compile and maintain Technical Data Sheets, Risk Management files (ISO 14971), clinical evaluation inputs and labeling/artwork approvals.
• Coordinate cross‑functional inputs from R&D, QA, Production, and Marketing for regulatory submissions and change control requests.
• Track regulatory changes (IMDR 2017, EU guidance, local country regulations) and recommend compliant strategies.
• Support product lifecycle management: variations, notifications, renewals and post‑market vigilance reporting.

This role demands accuracy, strong technical writing, and the ability to manage multiple regulatory timelines concurrently.

Eligibility / Qualifications

Mandatory qualification: B.Pharm or M.Pharm or a relevant degree in Pharmacy, Biomedical Sciences, or Engineering with medical device orientation.

Experience: 0–4 years in medical device regulatory affairs or related quality/regulatory roles. Candidates with direct exposure to ocular devices, Class II/III product submissions, or international registration experience will be preferred.

Technical skills and knowledge:

• Working knowledge of EU‑MDR, CE Certification processes, UKCA conformity, ISO 13485, MDSAP and IMDR 2017.
• Experience preparing Technical Files/Design Dossiers and Risk Management (ISO 14971).
• Familiarity with international registration processes (LATAM, MENA, APAC, Africa, Australia).
• Understanding of clinical evaluation reports, post‑market surveillance and vigilance reporting.
• Strong technical writing skills, attention to detail, and experience with regulatory tracking tools or document management systems.

Soft skills: Good communication, stakeholder coordination, time management, and the ability to work cross‑functionally with R&D, QA, production and marketing teams.

Courses & Relevant Background:
Pharmacy, Regulatory Affairs, Biomedical Engineering, Life Sciences, Biotechnology, Clinical Research, Quality Assurance, Medical Device Design, ISO 13485 lead auditor courses.

Location & Salary

Location: Kheda, Gujarat.
Amanta provides bus facilities to most areas of Ahmedabad, Kheda, Nadiad and Anand for employee commute convenience.

Salary: Negotiable and aligned with candidate experience and industry benchmarks for medical device regulatory roles.

Application Process

If you meet the qualification and are passionate about regulatory affairs for medical devices, submit your CV to sumit_dwivedi@amanta.co.in with the subject line: Application – Regulatory Affairs – Ocular. Include a one‑page summary of your regulatory experience and highlight any submissions or certifications you contributed to.

FAQs

Q: What is the minimum experience required for this role?
A: The role accepts candidates with 0–4 years of medical device regulatory experience. Freshers with relevant internships or exposure to regulatory documentation may be considered.

Q: Which regulations should I be familiar with?
A: EU‑MDR, ISO 13485, MDSAP, UKCA, IMDR 2017 and CE marking processes. Practical familiarity with country‑specific registration requirements is an advantage.

Q: Does Amanta provide transport?
A: Yes. Bus facilities are provided to most areas of Ahmedabad, Kheda, Nadiad, and Anand.

Q: Will I be handling global registrations?
A: Yes. The role requires support for international registrations across EU, LATAM, MENA, Asia‑Pacific, Africa, Great Britain, and Australia.

Q: Is the salary fixed?
A: Salary is negotiable and will depend on experience, qualification and fit for the role.

Q: How do I apply if I have no prior device experience but a strong regulatory background in pharma?
A: Highlight transferable skills — technical writing, risk management, quality systems knowledge (ISO 13485/ISO 9001) and any exposure to device‑related pathways. Candidates with such profiles can be considered for a learning curve.

Documents to include with application

• Updated CV with detailed role descriptions
• One‑page regulatory experience summary
• Copies of relevant certificates (B.Pharm/M.Pharm, regulatory training, ISO 13485 auditor course if any)
• Any submission summaries or certificates of registration (if available)

Closing Note

This is an opportunity to join a focused regulatory team within a company that values compliance and global market access. If you are serious about building a career in medical device regulatory affairs, especially in ocular devices, Amanta Healthcare offers a practical, hands‑on role with exposure to international regulatory strategy and certification processes.

Summary Table

Category	Details
Company	Amanta Healthcare Ltd.
Vacancies	Sr. Officer / Executive – Regulatory Affairs (Medical Devices – Ocular) (01)
Required Education	B.Pharm, M.Pharm, Pharmacy, Biomedical Sciences, Regulatory Affairs, Life Sciences
Experience	0–4 years (Medical device regulatory affairs)