HCLTech Hiring Regulatory Affairs Associate

Regulatory Affairs Associate | HCLTech Madurai | B.Pharm, Biomedical, Mechanical

Apply for Regulatory Affairs Associate at HCLTech, Madurai. 2–5 years of experience in medical devices QA/RA required. On-site full-time role.

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HCLTech, a leading global technology and engineering company, is seeking talented professionals for the position of Regulatory Affairs Associate in Madurai, Tamil Nadu, India. This is a full-time, on-site opportunity designed for individuals with strong experience in Medical Devices Regulatory Affairs, Quality Assurance, and Documentation.

If you are a B.Pharm, Biomedical, or Mechanical Engineering graduate with 2–5 years of industry experience, this role offers you the platform to advance your career in global regulatory compliance and medical device quality management.

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Company Overview

HCLTech is one of the world’s top IT and engineering services organizations, with a robust presence in life sciences, healthcare, and medical device industries. With over four decades of innovation, HCLTech partners with global medical device and pharma leaders to deliver end-to-end regulatory, R&D, and digital engineering solutions.

The company’s Life Sciences and Healthcare division focuses on digital transformation, product compliance, and regulatory excellence for global clients, ensuring patient safety and adherence to international standards such as FDA QSR, EU MDR, and ISO 13485.

At HCLTech, employees enjoy a collaborative, innovation-driven culture, where continuous learning and domain expertise fuel professional growth.

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Job Role & Responsibilities

As a Regulatory Affairs Associate, you will be responsible for supporting global medical device regulatory submissions, quality documentation, and compliance activities that ensure alignment with international medical device standards.

Key Responsibilities:

• Assist in preparing and reviewing regulatory documentation, technical files, and DHFs (Design History Files).
• Conduct DHF assessments and participate in remediation activities to ensure compliance with applicable standards.
• Ensure compliance with FDA 21 CFR Part 820.30, ISO 13485:2016, EU MDR, and other international medical device regulations.
• Support change control processes, deviation records, and validation report documentation.
• Collaborate with cross-functional teams on regulatory submissions and audits.
• Maintain up-to-date knowledge of evolving global medical device regulations and requirements.
• Ensure proper documentation practices and data integrity in accordance with quality systems.

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Eligibility / Qualifications

Education:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or Pharmacy (B.Pharm).

Experience:

• Minimum of 2–5 years of experience in Regulatory Affairs, Quality Assurance, or Documentation for medical devices.

Technical Skills:

• Knowledge of FDA QSR, ISO 13485, EU MDR, IEC standards.
• Strong documentation and validation skills (reports, protocols, CAPA, and change control records).
• Proficiency in quality management systems and design control processes.
• Excellent communication skills (verbal and written).

Preferred Qualifications:

• Experience in DHF assessment and remediation.
• Exposure to risk management (ISO 14971) and design validation.

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Location & Salary

• Location: Madurai, Tamil Nadu, India
• Work Type: On-site
• Employment Type: Full-Time, Regular
• Experience Required: 2–5 years
• Compensation: Competitive salary based on experience, with additional benefits and performance incentives.

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Application Process

Interested and qualified candidates can apply through HCLTech’s official job portal or the company’s LinkedIn job listing. Ensure that your resume highlights relevant regulatory and QA experience in the medical device industry.

👉 Apply Here – HCLTech Careers Portal

⚠️ Apply soon – limited positions available for Regulatory Affairs professionals in Madurai!

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Why Join HCLTech?

• Be part of a global engineering leader supporting top-tier medical device clients.
• Exposure to international regulatory frameworks like FDA, EU MDR, and ISO standards.
• Work in a fast-paced, innovation-driven environment that values technical excellence and career growth.
• Gain expertise in regulatory documentation, design control, and compliance with hands-on projects.
• Benefit from HCLTech’s commitment to employee learning, diversity, and global career development.

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FAQs

Q1: What qualifications are required for the Regulatory Affairs Associate role at HCLTech?
A bachelor’s degree in Biomedical, Mechanical, or Pharmacy (B.Pharm) is required.

Q2: How many years of experience are needed?
Candidates should have 2–5 years of experience in regulatory affairs, QA, or documentation within the medical device industry.

Q3: What are the core skills required?
Strong knowledge of FDA QSR, ISO 13485, EU MDR, and documentation processes.

Q4: Is this an on-site or remote role?
This is an on-site, full-time position based in Madurai, Tamil Nadu.

Q5: What is the last date to apply?
Applications are open until positions are filled. Early application is advised.

Q6: What makes HCLTech a good employer for regulatory professionals?
HCLTech provides global exposure, professional development programs, and a culture of excellence in life sciences and medical device domains.

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Call to Action

Don’t miss this excellent opportunity to build a rewarding career in Regulatory Affairs with HCLTech — one of the world’s most innovative and respected technology companies.

🚀 Apply now to join HCLTech’s Medical Devices Regulatory Affairs team in Madurai and shape the future of healthcare compliance.

👉 Click Here to Apply – HCLTech Regulatory Affairs Associate

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Summary Table

Category	Details
Company	HCLTech
Vacancy	Regulatory Affairs Associate
Required Education	Biomedical, Mechanical, B.Pharm
Experience	2–5 Years
Location	Madurai, Tamil Nadu, India
Department	Regulatory Affairs / Quality Assurance
Job Type	Full-Time, On-site
Apply Link	Apply Here

Tagged as: Pharma Jobs in Chennai