Job
Description
Job Title: Head – Quality Assurance & Regulatory Affairs (Medical Devices) Location: Visakhapatnam /Chennai Position Type: Full-Time Experience Level: Senior (Individual Contributor + Leadership Oversight) Reports To: CEO / COO / Head of Operations About the Role We are looking for a highly experienced and execution-driven QA/RA professional to lead our Quality and Regulatory function as we scale medical device manufacturing under FDA and EU MDR frameworks. This role is ideal for someone who combines deep regulatory expertise with a hands-on approach —someone who leads by doing, not just directing. You will be responsible for establishing and maintaining the entire Quality Management System (QMS) , ensuring regulatory compliance, and guiding the company through audits, certifications, and product registrations—while also being actively involved on the ground with documentation, process qualification, and compliance monitoring. Key Responsibilities Own and lead all aspects of Quality Assurance and Regulatory Affairs for medical device manufacturing and compliance Establish, implement, and maintain a fully compliant QMS aligned with ISO 13485 , FDA 21 CFR Part 820 , and EU MDR requirements Prepare and manage technical documentation , regulatory submissions , design dossiers , risk files , and CE/FDA pathways Act as the Management Representative for audits, inspections, and regulatory communications Lead internal audits , CAPAs , nonconformance investigations , and supplier qualification processes Oversee validation and qualification protocols (equipment, process, software) and ensure traceability and documentation control Guide the team through design transfer and ensure manufacturing readiness Develop and enforce quality culture across functions and teams Provide strategic regulatory guidance while staying actively involved in the execution of QA/RA tasks Qualifications Bachelor's or Master’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field 7–12 years of experience in medical device QA/RA , with at least 3+ years in a leadership role Proven track record of working with FDA (QSR) , ISO 13485 , and EU MDR frameworks Experience in leading regulatory submissions for 510(k), CE Marking, and ISO audits Strong documentation, technical writing, and compliance skills Comfortable being hands-on: writing procedures, reviewing records, attending floor-level quality issues Excellent communication and leadership skills; able to interface with auditors, regulators, and internal teams Experience in a start-up or scale-up manufacturing environment is a strong plus What We’re Looking For A doer and leader who takes ownership and drives outcomes Someone who can build and lead systems , but also get into the details when required A compliance-focused mindset with the practicality to operate in a dynamic environment Someone passionate about building safe, effective, and regulatory-compliant medical technologies To Apply: Please send your resume and a short note on your most relevant QA/RA leadership experience to hr@adiuvodiagnostics.com Show more Show less
