Regulatory Affairs Job at HCLTech | BPharm Graduates Apply Now
Exciting career opportunities are open for professionals in Quality Assurance (QA), Regulatory Affairs (RA), and Documentation within the Medical Devices domain. If you have hands-on experience with FDA, ISO 13485, and EU MDR regulations, this Regulatory Affairs Job offers a chance to advance your career in a fast-growing and highly regulated healthcare technology field.
About the Company:
At our innovative organization, we focus on advancing medical technology to improve patient care. We are dedicated to excellence in our products and services, ensuring compliance with global standards while fostering a culture of continuous improvement and professional growth.
About the Job:
They are hiring skilled and experienced professionals for Quality Assurance, Regulatory Affairs, and Documentation positions in the Medical Devices industry. The ideal candidates will bring strong regulatory understanding, technical documentation experience, and an eye for compliance in a global regulatory environment.
Quality Assurance Job Details:
- Experience: 2 to 5 years
- Education: Bachelor’s degree in Pharmacy
- Location: India (specific location to be confirmed)
- Industry: Medical Devices / Healthcare / Life Sciences
Skills & Requirements:
- Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation
- Strong knowledge of global regulatory frameworks: FDA QSR, ISO 13485, EU MDR, IEC standards
- Experience in DHF assessment and remediation
- Familiarity with FDA 21 CFR Part 820.30 and ISO 13485:2016 design control requirements
- Documentation skills – validation reports, change control, deviation records
- Strong communication skills, both written and verbal
Why This Role?
This Quality Assurance Job offers an exceptional opportunity to contribute to the innovation, safety, and compliance of life-saving medical technologies. Working in Quality Assurance, Regulatory Affairs, or Documentation within the Medical Devices domain allows you to play a direct part in ensuring that products meet the highest international standards and improve patient outcomes worldwide. With hands-on exposure to FDA, ISO 13485, and EU MDR frameworks, this position provides a strong foundation for long-term career growth in a fast-evolving, globally regulated industry.
It’s an ideal choice for professionals who are detail-oriented, passionate about healthcare technology, and eager to make an impact by bridging science, regulation, and quality. Joining this organization means becoming part of a forward-thinking team that values technical excellence, innovation, and continuous professional development.
