Regulatory Affair Manager (Health)

  • Sector: 健康
  • Contact: Joh Sakdochot
  • Contact Email: j.sakdichot@monroeconsulting.co.th
  • Location: 曼谷
  • Salary: THB80000 - THB111000 per month
  • Expiry Date: 16 November 2022
  • Job Ref: BBBH372334_1663422959

Executive recruitment company Monroe Consulting is recruiting on behalf of an international market research company in Bangkok. The company has been providing market research solutions and consultation to various industries such as consumer, retail and soon covering new industries.

The position will be responsible for overall leadership of the business unit in Quantitative Department and to set up new team staffs and develop new businesses to new industries.

Job responsibilities

  • 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.

Job Requirements

  • 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.