Apply for HCLTech Hiring for Regulatory Affairs Associate job in Madurai. 2–5 years experience in medical devices regulatory compliance required.
About HCLTech
HCLTech is one of the world’s leading global technology companies, driving digital transformation for clients across industries including healthcare, life sciences, and medical devices. Headquartered in Noida, India, and operating in over 50 countries, HCLTech delivers next-generation engineering, IT, and regulatory solutions that enable innovation and compliance in a rapidly changing global environment. HCLTech Hiring for Regulatory Affairs Associate
As a Fortune 500 company, HCLTech is known for its commitment to employee growth, inclusive culture, and technological excellence. The company is now inviting experienced regulatory professionals to join its Medical Device Regulatory Affairs team in Madurai, Tamil Nadu. HCLTech Hiring for Regulatory Affairs Associate
This opening for the position of Regulatory Affairs Associate is a great opportunity for candidates with backgrounds in Biomedical Engineering, Mechanical Engineering, or Pharmacy (B.Pharm) who want to build a rewarding career ensuring regulatory compliance and patient safety across global medical device markets. HCLTech Hiring for Regulatory Affairs Associate
About the Role: Regulatory Affairs Associate
The Regulatory Affairs Associate at HCLTech will play a key role in supporting regulatory and quality assurance activities for international medical device projects. The position involves preparing and maintaining documentation, managing design controls, and ensuring compliance with global standards such as FDA QSR, ISO 13485:2016, and EU MDR. HCLTech Hiring for Regulatory Affairs Associate
In this role, you will collaborate with cross-functional engineering, quality, and documentation teams to ensure that all regulatory deliverables meet audit and submission requirements. The job is designed for professionals who can balance technical understanding with meticulous attention to detail. HCLTech Hiring for Regulatory Affairs Associate
Key Responsibilities
As a Regulatory Affairs Associate at HCLTech, your primary responsibilities will include:
- Supporting Regulatory Affairs and Quality Assurance teams in preparing and maintaining compliance documentation for medical device projects.
- Preparing, reviewing, and updating Design History Files (DHF), validation reports, and records related to change control, deviation management, and corrective actions.
- Ensuring adherence to FDA Quality System Regulations (21 CFR Part 820), ISO 13485:2016, EU MDR, and IEC standards applicable to medical devices.
- Participating in design control activities, including risk management and DHF remediation.
- Coordinating with project teams to ensure that regulatory submissions are timely and accurate.
- Maintaining technical documentation, validation reports, and audit-ready files in alignment with both global and local compliance requirements.
- Collaborating with cross-functional teams—including R&D, Engineering, Quality, and Operations—to maintain continuous compliance.
- Supporting regulatory audits and contributing to regulatory responses, corrective actions, and continuous improvement initiatives.
These responsibilities require both technical proficiency and a deep understanding of medical device regulations, ensuring that every product developed aligns with international quality and safety expectations. HCLTech Hiring for Regulatory Affairs Associate
Educational Qualifications and Experience Required
To qualify for the Regulatory Affairs Associate role at HCLTech, candidates must meet the following educational and professional criteria: HCLTech Hiring for Regulatory Affairs Associate
Education:
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or Bachelor of Pharmacy (B.Pharm) from a recognized institution.
Experience:
- 2–5 years of experience in Regulatory Affairs, Quality Assurance, or Documentation roles within the medical device industry.
- A minimum of 3 years of direct regulatory experience is preferred.
Technical and Regulatory Knowledge:
- Thorough understanding of FDA Quality System Regulation (21 CFR Part 820).
- Familiarity with ISO 13485:2016, EU Medical Device Regulation (MDR), and IEC 60601/62304 standards.
- Experience in validation documentation, change control, CAPA, and risk management processes.
- Ability to interpret and implement evolving global regulatory requirements.
Skills:
- Excellent written and verbal communication abilities.
- Strong technical writing skills for regulatory submissions and audit documentation.
- Attention to detail and capability to manage multiple regulatory projects simultaneously.
- Collaborative mindset with the ability to work in cross-functional, multicultural teams.
Why Join HCLTech?
Working at HCLTech offers more than just a job—it provides a platform to grow your career in a global, innovation-driven organization. As part of the Engineering and Medical Device Regulatory Affairs team, you will be contributing to projects that make a difference in healthcare worldwide. HCLTech Hiring for Regulatory Affairs Associate
Key Benefits of Joining HCLTech:
- Competitive Salary Packages:
Attractive compensation structure with additional performance-based annual bonuses. - Learning and Development:
HCLTech provides access to specialized training programs in regulatory affairs, quality systems, and digital tools, enabling continuous upskilling. - Global Exposure:
Work with international medical device manufacturers, regulatory agencies, and global clients on compliance projects. - Career Growth Opportunities:
A clearly defined growth path within the Regulatory Affairs domain leading to Senior Associate, Specialist, or Lead Regulatory roles. - Inclusive Work Culture:
A collaborative, employee-first environment that values diversity, innovation, and work-life balance. - Job Stability:
As one of India’s most stable and rapidly growing IT and engineering service providers, HCLTech ensures consistent project flow and long-term employment opportunities.
Location: Madurai, Tamil Nadu
This position is based at HCLTech’s Madurai center, one of the company’s key delivery hubs in South India. Madurai offers a balanced work-life environment, affordable living, and access to top-tier infrastructure while allowing employees to work on high-value international regulatory projects. HCLTech Hiring for Regulatory Affairs Associate
Remote and hybrid work arrangements may be available depending on project requirements and company policy.
About HCLTech’s Medical Device Division
HCLTech’s Engineering and R&D Services (ERS) division is a global leader in providing end-to-end product development, quality assurance, and regulatory compliance solutions for the medical devices and healthcare industry. HCLTech Hiring for Regulatory Affairs Associate
The company partners with leading global device manufacturers to ensure their products meet the highest regulatory and safety standards in markets governed by FDA (US), EMA (Europe), TGA (Australia), and other global authorities. HCLTech Hiring for Regulatory Affairs Associate
From design control to risk assessment, validation, and regulatory submission, HCLTech provides integrated compliance support to clients worldwide. As a Regulatory Affairs Associate, you will be contributing to this ecosystem, ensuring safer and more compliant medical technologies reach global markets. HCLTech Hiring for Regulatory Affairs Associate
Key Highlights of the Job
- Job Title: Regulatory Affairs Associate
- Company: HCLTech
- Location: Madurai, Tamil Nadu
- Experience Required: 2–5 years
- Educational Qualification: Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or B.Pharm
- Domain: Medical Devices, Regulatory Affairs, Quality Assurance, Documentation
- Job Type: Full-time, Permanent
- Application Mode: Online
How to Apply for HCLTech Regulatory Affairs Associate Job
Interested and eligible candidates can apply for this position through the official HCLTech careers portal. Follow the steps below to submit your application: HCLTech Hiring for Regulatory Affairs Associate
Steps to Apply Online:
- Visit the official HCLTech Careers website: https://www.hcltech.com/careers
- In the search bar, type “Regulatory Affairs Associate – Madurai” and press enter.
- Review the job details and click on “Apply Now.”
- Sign in or create a new account on the HCLTech job portal.
- Fill in your personal details, educational background, and professional experience.
- Upload your updated resume (in PDF format) and relevant certifications.
- Review all the information and click “Submit Application.”
Alternative Method:
You may also apply through verified job portals such as LinkedIn, Naukri, or Indeed, ensuring that the posting links directly to HCLTech’s official recruitment page.
Conclusion
The HCLTech Regulatory Affairs Associate position in Madurai is a fantastic opportunity for regulatory and quality professionals seeking to grow their careers in the medical device industry. With HCLTech’s global exposure, structured growth paths, and commitment to employee excellence, this role provides both professional development and job satisfaction. HCLTech Hiring for Regulatory Affairs Associate
If you are detail-oriented, passionate about compliance, and eager to work in one of India’s leading technology firms, apply today and join HCLTech in its mission to make healthcare safer and more compliant worldwide. HCLTech Hiring for Regulatory Affairs Associate
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
