Regulatory Affairs Manager / Director

Job Purpose :

Responsible for the products registration and renewals, as well as the fulfilment of all regulatory requirements to import, market and utilize company products. 

Key Responsibilities

• Develop new regulatory policies, processes and Standard Operating Procedures and train key personnel on them.
• Serve as Central Reference point for all regulatory affairs for both company and its suppliers.
• Assist as needed in providing necessary documentation or information to support import and export of regulated products, including FDA Importation Codes, and Certificates to Foreign Government for Medical Devices.
• Monitor and advise impact of changing regulations on submission strategies and update internal stakeholders.
• Assist in the development of multicounty regulatory strategy and update strategy based upon regulatory changes.
• Assist in regulatory due diligence for potential and new acquisitions. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
• Oversee processes involved with maintaining annual licenses, registrations, listing. Assist in regulatory inspections and third party audits, direct interactions with governmental agencies and consultants.
• Compile, prepare, review and submit regulatory submission to authorities. Report adverse events to regulatory agencies and internal stakeholders.
• Represent company to authorities whenever required.
• Provide strategic input and technical guidance on regulatory requirements to development teams.