Philips Senior Regulatory Affairs Manager in Seoul,
As the incumbent of Quality & Regulatory (Q&R) role within Philips, your challenge is to guide and support Philips Health Tech New Business Development throughout Market Access and Regulatory Compliance, in addition to lead Regulatory & Clinical Affairs team within Q&R HS Korea. This involves being a confident, competent, key enabler of Philips business growth, 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.
Guide and lead Regulatory & Clinical Affairs team to execute the Q&R responsibilities within the organization.
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
Set key initiatives and top priorities for Market Access and Product Registration projects to be accomplished within a specified timeframe, including NPI (New Product Introduction)
Ensure Country Regulatory Information (CRI) maintaining and monitoring
Partner and network with government bodies (e.g. MoHW, MFDS, HIRA, KTL and KMDIA) where relevant
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 team leader of Regulatory & Clinical Affairs, HS, Q&R, Korea, ASEAN Pacific Market.
You are empowered to represent as Philips, and 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 Market Access, an opinion leader as a member of global industrial bodies, AMCHAM, ECCK, AdvaMed, KMDIA, etc.
Working knowledge of Quality & Regulatory in a technical oriented environment preferably with experience of dealing with Korea MoHW, MFDS, HIRA and gov’t agencies responsible for medical device regulations.
Demonstrated ability to: take initiative, communicate with others, get results by convincing and perform thorough investigations.
Fluent in English and Korean, verbal and written communications.
Team leader, People manager