Award-winning executive recruitment company, Monroe Consulting Group Thailand is recruiting on behalf of a leading medical device company, which are known for their great career progression, flexible environment and opportunity to relocate overseas. This position of Regulatory Affair Manager is based in Bangkok.
The role will lead a team that carries out product registrations and ensure regulatory compliance to ensure market access and market continuity in Thailand and maintains positive relationships with customers with updates to all collaborators throughout the registration process.
- Take care of the Regulatory Affairs department.
- Sets the department's annual budget.
- Registers all products in line with business priorities.
- Ensures compliance for labeling and product licenses throughout the product lifecycle to requirements defined by local authorities and company policies.
- Become the company communication point with the regulatory authorities, industry groups, and customers to build and maintain the sustainable relationship.
- Approves local promotional material in accordance with the local advertising code and process.
- Develops, implements, and maintains standard operating procedures and resource documents and ensures the renewals process is on time.
- Monitors the country's regulatory requirements, provide regulatory intelligence to the regional team, and formulate an appropriate response or product development to any changes.
- Works closely with the supply chain, manufacturing, and commercial teams to ensure the response to any change due to regulatory requirements.
- Report every field action to regulatory authorities.
- Bachelor's degree in any related field.
- Possess interpersonal skills and the ability to build relationships with internal and external customers.
- People managing and Regulatory Affairs working experience
- Knowledge of ISO 13845 is preferred.
- Experience in the medical device industry is preferred
- The previous succession in leading a team is a huge benefit.
- Excellent knowledge of the regulatory process of medical devices.
- European Union Medical Device Directive or Medical Device Regulation experience is preferred.