You will have the opportunity to
ensure Philips regulatory compliance. This involves being a confident, competent, key enabler on product approval and certification maintenance, in order to achieve timely release of Philips innovative brand new products that deliver high quality and outstanding reliability to the lives that they will improve.
Prepare submissions of technical files, type tests and import licenses/certificates for new product registrations and/or modified product registrations to obtain medical product approvals within the identified timeframes.
Ensure product registration status, and work with responsible BGBU (Business Group and Business Unit) for product supply continuity with no supply impact due to product license amendment or expiry of registered products
Maintain regulatory compliance of registered products of Product DMR (Device Master Records) and Korea localization
Ensure Regulatory compliance to registered products, and analyze potential Regulatory issues to be appropriately escalated, and monitor follow-up actions to be executed where necessary
Perform regulatory assessments on international standards and country national deviations, and maintain compliance with the applicable regulations and Philips standards & policies
Ensure Country Regulatory Information (CRI) maintaining and monitoring
We are looking for
someone who has the resilience to overcome challenges, coupled with strong competencies, responsibilities, sense of urgency, and with a Quality mindset
Experienced in Quality & Regulatory in a technical oriented environment preferably with experience of dealing with Korea MFDS and gov’t agencies responsible for medical device regulations.
Working knowledge of relevant international/local/device Regulations.
Demonstrated ability to: take initiative, communicate with others, get results by convincing and perform thorough investigations.
Computer skills including database management, word processing and spreadsheets are also necessary.
Rigorous and precise work is compulsory.
Fluent in English and Korean, verbal and written communications.