Looking to build a career in regulatory affairs and quality assurance? Getinge, a global leader in medical technology, is hiring a Quality Regulatory Compliance Specialist in the Mumbai Metropolitan Region. This role offers an excellent opportunity for professionals who want to contribute to life-saving healthcare solutions while working in a dynamic and compliance-driven environment.
Job Overview
Getinge is seeking a skilled professional with experience in Quality Assurance (QA) and Regulatory Affairs (RA) within the medical device or pharmaceutical sector. The role focuses on maintaining compliance, supporting regulatory submissions, and ensuring adherence to global quality standards like ISO 13485.
Roles & Responsibilities
Quality Assurance (QA)
- Monitor regulatory changes, legislation, and standards impacting QMS
- Track country-specific regulatory requirements and provide insights
- Implement and maintain QMS aligned with global standards
- Manage document control for quality and regulatory documentation
- Support audits, CAPA, KPI reviews, and continuous improvement
- Handle complaint management and adverse event reporting
- Coordinate Field Safety Corrective Actions (FSCA)
- Maintain compliance with local regulatory authorities
Regulatory Affairs (RA)
- Prepare and compile product registration dossiers
- Manage license applications, renewals, and change notifications
- Ensure accurate and timely updates in regulatory databases
Required Qualifications
- Bachelorโs degree in Science or related field
- 1โ5 years of experience in Medical Device, Pharmaceutical, or related industry
Required Skills
- Knowledge of product registration and QMS processes
- Strong communication and coordination skills
- Good command of English (written & spoken)
- Proficiency in MS Office, SharePoint, MS Teams
- Ability to manage multiple tasks under pressure
- Strong interpersonal and teamwork skills
Salary & Benefits
- Estimated Salary: โน4,00,000 โ โน9,00,000 per annum
- Opportunity to work with a global healthcare leader
- Exposure to international regulatory standards
- Career growth in QA & Regulatory Affairs
- Professional and collaborative work environment
About Getinge
Getinge is a global medical technology company committed to improving patient outcomes. With operations in over 40 countries and products available in more than 135 countries, the company focuses on intensive care, cardiovascular procedures, operating rooms, and life science solutions.
How to Apply
Interested candidates can apply through the official career portal or via trusted job platforms. Ensure your resume highlights relevant experience in QA, Regulatory Affairs, and compliance.
Direct apply link: ๐
