GPC Medical Ltd.
Location
New Delhi | India
Job 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 Regulatory Affairs Executive located in New Delhi. As a Regulatory Affairs executive, you will be responsible for ensuring compliance with regulatory requirements at GPC Medical. Roles and Responsibilities · Prepare and update technical documentations as per EU MDR and 510 (k) regulatory requirements as required. · Prepare and update risk management and usability evaluation as compliance with ISO 14971 and IEC 62366-1 · Prepare or review labeling, IFU, surgical techniques and promotional materials for compliance with regulatory requirements. · Prepare and update divisional SOPs and recommend timely changes to ensure regulatory compliance. · Apply knowledge and understanding of the regulatory frameworks, processes, and procedures to maintain compliance. · Monitors and improves regulatory tasks tracking systems effectively and manage the team efficiently. · Effectively interact with internal stakeholders and external stakeholders (Notified Bodies, distributor, suppliers and other regulatory authorities) on defined matters. Qualifications Expertise in regulatory compliance and regulatory affairs management Ability to interpret and apply regulatory requirements. Strong knowledge of quality system regulations and standards Excellent written and verbal communication skills Bachelor's degree (B.TECH or B.PHARMA) in regulatory affairs, science, engineering, or related field Experience 1-2 years' experience in a similar role. Industry Medical Equipment Manufacturing Employment Type Full-timeJob tags
Salary
