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 Manager located in New Delhi. As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements and managing regulatory submissions 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 and update PMS, PMCF, PSUR & clinical evaluation file as per compliance with Regulation (EU) 2017/745. · 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. · Prepare registration dossier for the specific country requirement. · Leads and compiles all documents required in submissions, license renewal and annual registrations in line with business plans · 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. · Identify and assess changes in applicable regulations, standards and guidance and perform changes accordingly and maintain the product compliance. · Effectively interact with internal stakeholders and external stakeholders (Notified Bodies, distributor, suppliers and other regulatory authorities) on defined matters. · Face external audits / inspection, coordinate and communicate with external auditors / inspectors for compliance. 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 7-8 years' experience in a similar role.Job tags
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