Company Description V Reg Solutions LLP is a medical device consultancy that supports manufacturers in navigating complex regulatory requirements across global markets. The organization specializes in device classification, validation, testing, and country-specific registrations, with a strong focus on timely and compliant submissions. Using a risk-based approach, V Reg Solutions LLP works to ensure thorough, accurate applications that facilitate streamlined regulatory approvals.

The team partners closely with clients to optimize regulatory strategies and reduce time-to-market for innovative medical devices.

Role Description The RA/QA Specialist is a full-time, on-site role based in Ahmedabad. This position is responsible for supporting regulatory submissions, maintaining quality documentation, and ensuring compliance with applicable medical device regulations and standards. Day-to-day tasks include preparing and reviewing technical files, assisting with regulatory applications, and coordinating with cross-functional teams to gather required data and evidence.

The RA/QA Specialist will monitor quality processes, support internal audits, track corrective and preventive actions (CAPA), and help maintain compliance with Good Manufacturing Practice (GMP) and relevant quality management systems.



The role also involves drafting and updating standard operating procedures (SOPs), participating in risk assessments, and providing regulatory and quality guidance to project teams.

Qualifications

- Strong Quality Control and Quality Assurance skills, with experience in implementing and monitoring quality procedures.

- Knowledge of Quality Management systems, including establishing, maintaining, and improving documented processes.

- Understanding and practical application of Good Manufacturing Practice (GMP) in a medical device or related regulated environment.

- Experience in Quality Auditing, including conducting internal audits and supporting external or regulatory inspections.

- Bachelor’s degree in engineering, life sciences, pharmacy, or a related discipline; advanced qualifications in regulatory affairs or quality management are an advantage.

- Familiarity with medical device regulations and standards (e.g., ISO 13485, EU MDR, FDA requirements) is highly beneficial.

- Solid analytical, documentation, and organizational skills, with attention to detail and accuracy.

- Effective written and verbal communication skills, and ability to work collaboratively in cross-functional teams.

📌 RA/QA Specialist (Ahmedabad)
🏢 V Reg Solutions
📍 Ahmedabad