Regulatory Affairs Officer (Medical equipment Male candidate) Cnergy Ortho Care

4.0 - 5.0 years

3 - 7 Lacs

Chennai

Work from Office

Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, amendments and post-market surveillance req...

Posted 5 months ago

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Executive/ Sr. Executive- Regulatory Affairs (RA) Auxein Medical

2.0 - 7.0 years

3 - 8 Lacs

Sonipat

Work from Office

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Posted 5 months ago

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Quality Control Engineer George Philips Medical Engineering

2.0 - 5.0 years

2 - 5 Lacs

Thane

Work from Office

Job Summary We are looking for a detail-oriented and experienced Quality Control Engineer to join our manufacturing team. The ideal candidate will be responsible for implementing and overseeing quality control processes, ensuring all products meet national and international medical device standards, and working closely with production and R&D to resolve quality issues. Key Responsibilities Conduct in-process and final quality inspections for medical devices in accordance with GMP and ISO 13485 standards. Develop and maintain QC protocols, SOPs, and inspection reports. Ensure compliance with regulatory requirements such as CDSCO, MDR 2017, ISO 13485, and CE. Perform root cause analysis and co...

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Design Quality Engineer Respironics Inc

8.0 - 10.0 years

0 Lacs

Pune, Maharashtra, India

On-site

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer - Medical Devices The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role: Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like usability, reliability, performance, supportabili...

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Labeling and Technical Publications Bean Hr Consulting

7 - 11 years

18 - 25 Lacs

Gurugram, Bengaluru

Work from Office

Designation: Staff Specialist Labeling & Technical Publications Experience: 7–11 years Location: Gurgaon (GGN) or Bangalore (BLR) Interview Rounds: 8 Work Mode: Hybrid / Onsite Role Overview We are seeking a highly skilled professional to manage and coordinate global labeling and technical publications for medical device products. This role involves regulatory documentation, translation workflows, quality compliance, and cross-functional project leadership within a regulated environment. Key Responsibilities Manage and approve labeling jobs using tools like Microsoft Teams Planner and PLM systems. Coordinate document translations with external vendors and ensure regulatory compliance. Publis...

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Regulatory Affairs Specialist Saraca Solutions

4 - 8 years

13 - 18 Lacs

Hyderabad

Work from Office

• 4-7 years experiences for RA role in medical device and or pharmaceutical industry • Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.

Posted 6 months ago

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