Saraca Solutions is inviting applications for the position of Quality and Regulatory Affairs Specialist in Noida, Delhi NCR. This opportunity is ideal for fresh graduates interested in regulatory affairs, medical devices compliance, and technical documentation.
The role focuses on regulatory compliance for medical devices across the EU, India, and US markets, including USFDA regulations and European Union Medical Device Regulation (EU MDR). Candidates will also contribute to medical writing, regulatory documentation, and quality compliance activities within the organization.
This position provides early-career professionals an opportunity to build expertise in medical device regulatory affairs, global compliance frameworks, and technical documentation management.
Job Overview
- Position: Quality and Regulatory Affairs Specialist
- Company: Saraca Solutions
- Location: Noida, Delhi NCR, India
- Experience: 0โ1 Years
- Employment Type: Full-Time, Permanent
- Department: Research & Development
- Role Category: Pharmaceutical & Biotechnology
- Salary: โน2.75 โ โน3.25 LPA (Approx.)
Key Responsibilities
The selected candidate will work on regulatory and quality compliance activities related to medical devices and healthcare products.
Key responsibilities include:
- Preparing and maintaining regulatory documentation for medical devices
- Supporting compliance with USFDA, EU MDR, and Indian regulatory guidelines
- Assisting in technical documentation and regulatory submissions
- Contributing to medical writing and clinical evaluation reports
- Reviewing product documentation to ensure regulatory compliance standards
- Supporting quality management system (QMS) processes
- Coordinating with cross-functional teams on regulatory requirements
- Monitoring regulatory updates related to medical device regulations
Required Qualifications
Candidates applying for the Regulatory Affairs Specialist job at Saraca Solutions should meet the following criteria:
Education
- B.Tech Biotechnology or related Life Sciences degree
- Fresh graduates are eligible to apply
Skills
Preferred skills include:
- Regulatory Affairs knowledge
- Medical Device Regulations
- EU MDR (European Union Medical Device Regulation)
- USFDA guidelines and compliance
- Medical writing and technical documentation
- Quality documentation and compliance
- Clinical evaluation documentation
Candidates with basic knowledge of global regulatory frameworks for medical devices will have an advantage.
Salary and Benefits
Saraca Solutions offers a competitive salary package along with professional development opportunities.
Expected salary range:
โน2.75 LPA โ โน3.25 LPA
Benefits may include:
- Exposure to global medical device regulatory frameworks
- Experience in USFDA and EU MDR compliance
- Career growth in regulatory affairs and medical writing
- Hands-on work in technical documentation and compliance management
Why This Role is Valuable for Regulatory Careers
The Regulatory Affairs Specialist role offers an excellent entry point into the medical device regulatory domain.
Professionals in this field gain experience in:
- Global medical device regulatory pathways
- Technical file preparation and regulatory submissions
- Quality compliance frameworks
- International standards including EU MDR and FDA regulations
These skills are highly valuable for careers in regulatory affairs, quality assurance, and medical device compliance.
How to Apply
