Medfins Hiring Regulatory Affairs Executive

Medfins International LLP is currently hiring for the position of Regulatory Affairs Executive specializing in Medical Devices and IVD (In-Vitro Diagnostics). This opportunity is ideal for candidates with 2–3 years of experience in regulatory compliance, CDSCO licensing, and medical device documentation. The role is based in Chennai and offers strong career growth in the high-demand medical devices regulatory sector. While this is not a fresher role, candidates with relevant hands-on experience in regulatory submissions and compliance can significantly advance their careers in this specialized domain.

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Company Overview

Medfins International LLP is a growing healthcare and regulatory consulting organization focused on medical devices, diagnostics, and compliance services. The company plays a crucial role in helping organizations navigate complex regulatory pathways in India and global markets.

With expertise in CDSCO approvals, MDR 2017 compliance, and regulatory documentation, Medfins supports manufacturers and importers in achieving faster approvals and maintaining regulatory standards. Their work directly contributes to improving healthcare accessibility by ensuring safe and compliant medical devices reach the market.

Working at Medfins offers professionals exposure to high-value regulatory consulting, quality management systems, and international compliance frameworks, making it an excellent platform for long-term career growth in regulatory affairs and medical device compliance.

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Job Role & Responsibilities

As a Regulatory Affairs Executive in the medical devices and IVD domain, you will be responsible for handling regulatory documentation, licensing processes, and compliance activities aligned with Indian regulatory authorities.

Key Responsibilities:

• Manage CDSCO licensing processes including manufacturing, import, and testing approvals
• Prepare and compile DMF (Drug Master File), PMF (Plant Master File), and technical dossiers
• Handle regulatory submissions in compliance with MDR 2017 guidelines
• Respond to regulatory queries, deficiencies, and approval-related communications
• Ensure compliance with ISO standards and regulatory frameworks
• Maintain proper documentation and regulatory records for audits and inspections
• Coordinate with cross-functional teams for regulatory data collection and submissions
• Support risk management and quality management system (QMS) implementation

Core Expertise Required:

• Strong knowledge of CDSCO regulations and MDR 2017 guidelines
• Hands-on experience in regulatory submissions and documentation
• Familiarity with medical device regulatory lifecycle and approval processes
• Understanding of ISO standards and compliance requirements

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Eligibility / Qualifications

Candidates must meet the following criteria to apply for this regulatory affairs role:

Required Education:

B.Pharm, M.Pharm, BSc, MSc (Life Sciences, Biotechnology, Microbiology, Medical Devices, Clinical Research, Pharmaceutical Sciences)

Experience:

• 2 to 3 years of experience in Medical Devices or IVD Regulatory Affairs
• Proven experience in CDSCO licensing and regulatory submissions

Key Skills:

• Strong documentation and technical writing skills
• Knowledge of regulatory compliance and submission processes
• Understanding of QMS and risk management principles
• Effective communication and coordination abilities

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Location & Salary

Job Location:

Chennai, India

Salary:

Competitive salary package based on experience, regulatory expertise, and knowledge of CDSCO and MDR guidelines. Candidates with strong documentation and submission experience can expect better compensation aligned with industry standards.

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Application Process

Interested candidates can apply by submitting their updated resume through email.

Apply via Email:

info@medfinsinternational.com

Website:

https://www.medfinsinternational.com

Ensure your resume highlights your experience in regulatory submissions, CDSCO licensing, and medical device compliance to improve your chances of selection.

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Why This Role Matters in Healthcare & Medical Devices

Regulatory Affairs in medical devices and IVD is one of the fastest-growing domains in the healthcare industry. Professionals in this field ensure that diagnostic tools and medical equipment meet safety, quality, and regulatory standards before reaching patients.

This role directly impacts patient safety and healthcare innovation by enabling timely approvals and compliance with national and international regulations. With increasing demand for medical devices and diagnostics, regulatory professionals are highly valued across the pharmaceutical and healthcare sectors.

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Frequently Asked Questions (FAQs)

1. Who can apply for this Regulatory Affairs Executive role?

Candidates with relevant degrees and 2–3 years of experience in medical device or IVD regulatory affairs can apply.

2. Is CDSCO experience mandatory?

Yes, hands-on experience in CDSCO licensing and submissions is essential for this role.

3. What is MDR 2017?

MDR 2017 refers to the Medical Device Rules in India that govern the approval and regulation of medical devices.

4. Is this role suitable for freshers?

No, this position requires prior experience in regulatory affairs and medical device compliance.

5. What kind of work will I handle?

You will manage regulatory documentation, submissions, approvals, compliance, and coordination with regulatory authorities.

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Summary

Company	Medfins International LLP
Vacancies	Regulatory Affairs Executive (Medical Devices & IVD)
Required Education	B.Pharm, M.Pharm, BSc, MSc (Life Sciences, Biotechnology, Microbiology, Pharma)
Experience	2–3 Years in Medical Devices / IVD Regulatory Affairs (CDSCO, MDR 2017)