- 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.
- Medical Equipment Manufacturing
senior qa/ra executive - Delhi, India - GPC Medical Ltd.
Description
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
• 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
Experience
5-6 years' experience in a similar role.
Industry
Employment Type
Full-time