Job overview
To be responsible for regulatory matters and requirements within the company to achieve agreed targets and schedules in order to maintain current/obtain new authorisations/registrations related to company products for APAC including Korea markets in compliance with all relevant regulatory legislation and guidelines.


Responsibilities and Accountabilities of the Role
1. For Korea 

• To execute Class 1-4 medical devices and post-approval management
• To monitor related regulations and to establish regulatory strategy
• To consul on approval work with overseas cross-functional teams
• To perform full cycle management including approval renewal and change management
• To maintain KGMP and Korea quality system operation in compliance with local regulations
• To serve as the Quality Manager (QA) of Sinclair Korea and to lead regulatory inspection
• To provide leadership and direction in the area of site qualification process and management.
• To conduct the internal training to Sinclair Korea team 

2. For APAC

• To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices in APAC markets
• To work with in-country distributors or contractors to determine regulatory requirements for product registrations in responsible regions.
• To ensure all authorisations / registrations related to established products are maintained
• To monitor pending submissions to ensure timely approvals. Communicate to cross-functional teams any identified    delays that may impact business expectations
• To interact with regulatory consultants, regulatory and trade associates and other third-party service providers to ensure their provision of any requested activities to agreed timescales
• To provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities
• To review and approve product artworks and partner marketing material according to the applicable regulations
• To maintain all submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information
• To identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs
• To raise purchase orders as necessary, manage invoices related to assigned work and assist in maintenance of tracking spreadsheets of costs for budgeting purposes
• To maintain monthly business reports as necessary
• To liaise with and assist vigilance team with respect to vigilance requirements of product dossiers and post marketing activities where necessary
• To organise consular and translation services
• To facilitate agreement between SPL Legal and in-market partners regarding PoA/LoA expectations
• To provide technical / regulatory input to CC Reg Assessments (APAC) and associated change notifications

Essential:
 Bachelor's degree (4 years) or higher

• 5-7 years of experience related to Korea medical device regulations
• 1-3 years of experience related to APAC medical device regulations
• Fluency in written and spoken English
• Ability to work independently and to find the resource/solution for any challenges

Desirable:

• Preference degree in biomedical engineering, pharmacy, life science, chemistry, etc.
• Preference will be given to those with RA/QA experience in high-risk medical devices
• Preference will be given to those with medical device RA qualifications