QA/RA-SENIOR EXECUTIVE

Company Description

GPC Medical Ltd. is an Indian hospital and medical supplies company with decades of experience supplying high-quality medical equipment and orthopedic implants/instruments all over the globe. The company is ISO 13485 Certified, WHO-GMP Compliant, and many of its products are CE Marked. GPC Medical specializes in Orthopedic Implants, Medical Disposables, Hospital Furniture & Autoclave Sterilizers, and its products are supplied to almost all European countries.

Role Description

This is a full-time on-site role as a Senior QA/RA Executive located in New Delhi. As a Senior QA/RA Executive, you will be responsible for ensuring compliance with regulatory requirements and managing regulatory submissions at GPC Medical.

Roles and Responsibilities

Proficient in drafting and evaluating documents in accordance with ISO 13485, EU-MDR, 21CFR820, Thai FDA, and Indian Medical Device Regulations, ensuring their effective implementation.

Compile regulatory documents (TMF/Dossiers) for submission.

Create Design files adhering to ISO 13485:2016, MDR, and USFDA standards.

Manage adverse event reporting to EU and other regulatory agencies.

Expertise in developing and updating risk management and usability evaluations compliant with ISO 14971 and IEC 62366-1.

Skilled in preparing and revising PMS, PMCF, PSUR, and clinical evaluation files, aligned with Regulation (EU) 2017/745.

Extensive knowledge of process and equipment qualification and validation.

Qualifications

• Expertise in regulatory compliance and regulatory affairs management
• Ability to interpret and apply regulatory requirements.
• Experience in managing regulatory submissions.
• Strong knowledge of quality system regulations and standards
• Excellent written and verbal communication skills
• Bachelor's degree in regulatory affairs, science, engineering, or related field
• Master's or other advanced degree in regulatory affairs or related field is a plus.

Experience

5-6 years experience in a similar role.