Job Description

Responsible for support of organizing Regulatory Affairs of consumer products.
In charge of medium to long-term Regulatory operations including local systems improvements, local staff training and future business expansion.

• Improve the regulatory management system with Regulatory Manager.
• Develop and implement a Regulatory Program including policies, procedures (SOPs), ensuring that all governmental regulatory regulations including MHRA requirements for company products are achieved.
• Prepare, record, and manage documents necessary to establish the system of Regulatory Affairs in order that company will have been selling regulatory products sustainably.
• SOPs of which include; The rules to record all information related with Regulatory Affairs/ The rules to maintain our certifications/ The guidelines to address new product developments
• Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes.
• In-charge with the timely approval and renewal of product licenses, company certificates, through working with Regulatory officials, Notified Body(s) and regulatory consultant(s).
• Deal with audits which are implemented by Notified Body(s) and consumers, which includes supporting our own factory(s) when audited in order to maintain our certificates.
• Review technical dossier of products and prepare additional documents where necessary.
• Handle post-marketing activities and yearly reporting requirements of company and product licences.
• Analyse relevant regulatory trends - Keep updated with regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
• Maintain a current awareness of the regulatory requirements for the general legislation and guidelines (for instance REACH and Environmental regulations including recycling etc...) in EU.

Required Knowledge, Skills, and Abilities

Bachelor’s Degree preferred Experiences in Regulatory Affairs or Certifications as Auditor of Notified Body(s) for CE certificated products MDR transition’s experiences desirable Strong computer skills including Microsoft Office and Databases. Communication skills-verbal and written of Chinese or Japanese Must be able to go on business travel