Philips Regulatory Specialist in Seoul,
As the incumbent of Quality & Regulatory (Q&R) role within Philips, your challenge is 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 BIUs 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
Perform regulatory assessments on international standards and country national deviations, and maintain compliance with the applicable regulations and Philips standards & policies
Analyze regulatory issues, i.e. governmental efforts, regulatory Warning letters and Recall safety review
Your team (Describe in 60 words)
As a top brand, we stand for Quality. Your team, Q&R is recently restructured to its organization to reinforce the strong Quality & Regulatory compliance in Health System (HS) of Philips Korea. Specializing key roles of Q&R in your team consists of 3 teams – Regulatory & Clinical Affairs, Quality Management System, and Compliance. You will be a Regulatory Specialist in Regulatory & Clinical Affairs, HS, Q&R, Korea, ASEAN Pacific Market.
You are empowered to expertise to have a positive impact on your team, our business and health technologies that will improve the health, well-being and care for people around the world, not only in Korea.
We are looking for
We are looking for someone who is excited by the unique professional challenges that has strong competences, responsibilities, sense of urgency, and demonstrates resilience challenging, prioritizing quality:
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 (ISO13485, IEC60601-1, software lifecycle management, relevant product approval 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.