Senior Regulatory Affairs Executive (Medical Devices MNC)

Job content

• Evaluate regulatory risks of Medical Business division policies, processes, procedures
• Develop new regulatory policies, processes and SOPs in Medical Business and train key personnel
• Prepare and maintain technical documentation packages to ensure regulatory requirements for product registration submissions to competent authorities are met in regional countries
• Update, renew and maintain document control system, including registration documents, files, records of new and existing product portfolio
• Monitor impact of changing regulations and update internal stakeholders
• Oversee processes involved with maintaining annual licenses, registrations, listings and import/export controls
• Review and approve advertising and promotional items to ensure regulatory compliance and ensure external communications meet regulations in Medical Business
• Provide regulatory input for product recalls and recall communications
• Coordinate and implement quality system standards required
• Responsible for proper documentation of internal and external audits
• Assist management in the implementation and maintaining of regulatory system; legal and compliance issues pertaining to quality management system
• Compile all regulatory data and framework to educate relevant / related stakeholders
• Other duties and projects, as assigned

• Min. Degree in Pharmacy, Pharmacology, Biology or any related subject.
• Min. 2 years Regulatory Affairs experience in the Medical Device / Pharmaceutical Industry.