Regulatory Affairs Head / RA Head

Urgent Requirement of Regulatory Affairs Manager.

Candidate having experience of Medical Device/Pharma or any other related industry will be given first preference. Those interested in a job can directly reach out on 7984420926 for more discussion.

Role & responsibilities

• Manage regulatory affairs for medical devices, ensuring compliance with EU-MDR, US FDA, ANVISA, MHRA, ISO 13485 standards.
• Develop and maintain regulatory documentation including CTDs, RA submissions, QMS systems.
• Conduct BMR reviews and quality audits to ensure adherence to process validation requirements.
• Collaborate with cross-functional teams to implement change controls and process improvements.
• Ensure timely submission of regulatory applications and maintain accurate records.
• Effectively registering in various countries. Looking after the audit criteria and requirements of various countries.
• Prepare and update technical documentations as per EU MDR and 510 (k), Indian MDR 2017 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, Clinical Testing and promotional materials for compliance with regulatory requirements.
• Prepare and update divisional SOPs and recommend timely changes to ensure regulatory compliance.
• Planning, Compilation, review and submission of Documents as per Country Specific regulatory guideline in medical device and coordinating with them for registration.
• 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. First preference will be given to NIPER pass outs.
• 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, USFDA, 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.