Regulatory Associate Job New Delhi: If you are a pharmacy, science, or biomedical engineering graduate looking to start your career in Regulatory Affairs and Quality Management Systems (QMS), Health Arx Technologies has announced an excellent opportunity for the position of Regulatory Associate in New Delhi. This role is ideal for fresh graduates and professionals with up to two years of experience who want to gain practical exposure to regulatory compliance, ISO standards, quality assurance systems, and medical device regulations.
The healthcare technology and medical device sectors are rapidly expanding, creating a growing demand for professionals who understand regulatory requirements, quality management systems, and compliance frameworks. This position offers an opportunity to work closely with experienced regulatory professionals while building expertise in internationally recognized standards such as ISO 9001, ISO 13485, and ISO 27001.
Regulatory Associate Job New Delhi Vacancy Overview
| Job Details | Information |
| Company | Health Arx Technologies |
| Job Title | Regulatory Associate |
| Experience Required | 0–2 Years |
| Salary | ₹2.5–3.5 Lakh Per Annum |
| Location | New Delhi, India |
| Employment Type | Full-Time, Permanent |
| Industry | Medical Devices & Equipment |
| Department | Quality Assurance |
| Role Category | Quality Assurance – Other |
About the Regulatory Associate Job New Delhi
The Regulatory Associate will support the Regulatory Affairs team in implementing and maintaining compliance frameworks within the organization. The selected candidate will receive hands-on exposure to quality management systems, regulatory documentation, audit processes, CAPA management, and regulatory registrations.
This role provides a strong foundation for individuals aspiring to build long-term careers in Regulatory Affairs, Medical Device Compliance, Quality Assurance, Quality Systems Management, and Healthcare Technology Regulatory Operations.
Professionals joining this position will gain practical experience in managing documentation, supporting internal and external audits, maintaining quality records, monitoring regulatory requirements, and ensuring compliance with industry standards.
Key Responsibilities Regulatory Associate Job New Delhi
Support Regulatory Documentation and Product Lifecycle Activities
The Regulatory Associate will assist in preparing, reviewing, and maintaining documentation related to product development and product lifecycle management. Accurate documentation is a critical aspect of regulatory compliance and quality assurance within the healthcare and medical device sectors.
Quality Management System (QMS) Support
Candidates will support the implementation and maintenance of processes aligned with:
- ISO 9001 Quality Management Systems
- ISO 13485 Medical Device Quality Management Systems
- ISO 27001 Information Security Management Systems
This exposure will help professionals understand globally recognized compliance standards that govern healthcare and medical device organizations.
Audit Coordination and Compliance Monitoring
The role involves supporting internal and external audits across departments, monitoring compliance activities, and assisting in identifying opportunities for process improvement.
Responsibilities include:
- Supporting audit preparation activities
- Assisting with audit documentation
- Monitoring audit findings
- Supporting corrective action implementation
CAPA Tracking and Quality Improvement
Corrective and Preventive Actions (CAPA) are essential components of quality management systems. The Regulatory Associate will assist in maintaining CAPA records, monitoring progress, and ensuring timely closure of quality-related actions.
Regulatory Compliance Management
The selected candidate will support regulatory tracking activities and stay informed about evolving regulatory requirements affecting the organization. This includes assisting with regulatory registrations, renewals, and documentation updates.
Internal Training and Management Review Support
The role also includes supporting:
- Internal training programs
- Management review meetings
- KPI tracking activities
- Departmental compliance reporting
These responsibilities provide exposure to organizational quality culture and continuous improvement initiatives.
Document Control Activities
Maintaining controlled documents is a critical regulatory requirement. The candidate will assist in:
- Document revision management
- Record maintenance
- Training record tracking
- Electronic quality system support
Collaboration with Quality Teams
The Regulatory Associate will work closely with Quality Assurance teams to understand organizational quality processes, systems, and compliance requirements.
This cross-functional exposure helps professionals develop a broader understanding of regulatory operations within healthcare organizations.
Educational Qualifications Required
Candidates with the following educational backgrounds are encouraged to apply:
- Bachelor of Pharmacy (B.Pharm)
- Bachelor of Science (B.Sc.)
- Biomedical Engineering
- Life Sciences
- Biotechnology
- Equivalent Science Disciplines
Additional Qualification Advantage
- Master’s Degree in Pharmacy, Science, Biotechnology, Biomedical Engineering, or related fields
- Final-year students are also eligible to apply
Experience Requirements
Health Arx Technologies welcomes applications from:
- Freshers
- Candidates with 0–1 year of experience
- Professionals with up to 2 years of experience
- Candidates with internship or academic project exposure in regulatory affairs, quality assurance, or compliance
This makes the opportunity particularly attractive for recent graduates seeking entry-level regulatory affairs jobs in India.
Preferred Skills and Knowledge
Successful candidates should possess or be willing to develop knowledge in the following areas:
Regulatory Affairs: Understanding regulatory frameworks and compliance requirements applicable to healthcare products and medical devices.
ISO Standards
Basic awareness of:
- ISO 9001
- ISO 13485
- ISO 27001
Knowledge of these standards can significantly enhance career prospects in quality assurance and regulatory affairs.
Regulatory Documentation: Experience with technical documentation, compliance records, quality documents, or academic project documentation will be beneficial.
CAPA and Audit Exposure
Any exposure to:
- Corrective and Preventive Actions (CAPA)
- Internal Audits
- Quality Management Systems
- Compliance Documentation
will be considered an advantage.
Attention to Detail: Strong documentation habits, organizational skills, and attention to detail are essential qualities for success in regulatory roles.
Why Choose a Career in Regulatory Affairs?
Regulatory Affairs is one of the fastest-growing career domains in the pharmaceutical, biotechnology, medical device, and healthcare technology industries. Regulatory professionals play a vital role in ensuring that products meet safety, quality, and compliance requirements before reaching patients and healthcare providers.
Benefits of pursuing a Regulatory Affairs career include:
- Strong industry demand
- Diverse career growth opportunities
- International career prospects
- Exposure to global regulatory standards
- Opportunities in pharmaceuticals, medical devices, biotechnology, and digital health
For fresh graduates, gaining practical exposure to ISO standards and quality systems early in their careers can significantly enhance long-term professional growth.
Salary and Career Growth
The offered salary range of ₹2.5–3.5 LPA is competitive for entry-level regulatory affairs professionals. Beyond compensation, the position provides valuable experience in:
- Regulatory Affairs
- Quality Management Systems
- Medical Device Compliance
- Audit Management
- CAPA Processes
- Regulatory Documentation
- ISO Compliance
These skills can open pathways to future roles such as:
- Regulatory Affairs Executive
- Quality Assurance Associate
- Compliance Specialist
- Regulatory Compliance Officer
- Quality Systems Executive
- Medical Device Regulatory Professional
How to Apply
Interested candidates who meet the eligibility criteria should apply at the earliest. Freshers with strong academic backgrounds, good documentation skills, and an interest in regulatory compliance are strongly encouraged to apply.
Click here to apply: Apply
This opportunity represents an excellent starting point for individuals seeking a rewarding career in Regulatory Affairs, Quality Assurance, and Medical Device Compliance.
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