Website:
vregsolutions.com
Job details:
Company Description V Reg Solutions LLP is a specialized medical device consultancy that supports manufacturers in navigating complex regulatory requirements. The organization provides expertise in device classification, validation, testing, and country-specific registrations to help clients achieve compliant market entry. With a strong focus on timely delivery, V Reg Solutions LLP applies a risk-based approach to ensure thorough and well-structured regulatory submissions. The company is committed to enabling streamlined approvals and building long-term partnerships with medical device manufacturers. Team members contribute directly to improving regulatory quality and patient safety worldwide.
Role Description The QA RA Compliance Specialist is a full-time, on-site role based in Ahmedabad, responsible for supporting regulatory and quality activities for medical device projects. Daily tasks include reviewing and maintaining quality documentation, assisting with regulatory submissions, and ensuring compliance with relevant standards and guidelines. The specialist will perform routine quality checks, support internal and external audits, and help implement corrective and preventive actions. The role also involves collaborating with cross-functional teams to align quality and regulatory requirements, monitoring changes in regulations, and contributing to continuous improvement of compliance processes. The QA RA Compliance Specialist will report findings and progress to senior team members and support clients in meeting regulatory timelines.
Qualifications
- Candidates should possess strong skills in Quality Control and Quality Assurance to ensure consistent compliance with established standards.
- Candidates should possess skills in Quality Management and Quality Auditing to support effective systems oversight and internal/external audit activities.
- Candidates should possess knowledge of Good Manufacturing Practice (GMP) to help maintain regulatory-compliant manufacturing and documentation processes.
- Relevant experience in medical devices, pharmaceuticals, or healthcare compliance is beneficial.
- Strong attention to detail, analytical thinking, and problem-solving abilities are required.
- Effective written and verbal communication skills, including the ability to prepare clear reports and documentation, are essential.
- Bachelor’s degree in engineering, life sciences, pharmacy, or a related field is preferred.
- Ability to work collaboratively in an on-site team environment in Ahmedabad and manage multiple projects and deadlines.
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