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/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.
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.
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.
Requirements
Bachelor s degree from relevant universities.
Minimum 8 year experience in Medical device with proven people management skills.
Should have knowledge and understanding of the regulatory frameworks, processes, and procedures to maintain compliance.
Should have knowledge of EU-MDR, FDA, MDCG, ISO 13485, ISO 14971, ISO 15223-1 and other regulatory standards.
Must have experience in technical dossier preparation.
Knowledge of IEC standards such as IEC 60601-1, IEC 62304, etc will be beneficial.
Knowledge of orthopedic implants, orthopedic instruments and Surgical Robotics Instruments will be preferred.
Good command of MS Office programs
Excellent communication, interpersonal and time management skills and ability to work in and lead cross functional teams,
Well organized, aptitude for paperwork, good follow-up skills, strong organizational and co-ordination skills,
Active and good listener, team player, effective problem solving skills, result and quality orientation,
Good command of both written and spoken English.
Experience in the medical device area is preferred.
