In this role, you have the opportunity to :
Contribute with your regulatory skills to the innovation of products and services focusing on improving people’s health. You and your operations team in collaboration with regulatory/ Q&R team in the markets, have strong interaction with innovation teams on Regulatory Affairs matters.
You are part of APAC team, and part of International Regulatory affairs team and will be reporting to Regulatory Affairs Director, International Markets.
You are responsible for:
Enabling all regulatory activities necessary to facilitate speed-to-market and to achieve all regulatory timelines and milestones as per APAC (including India) business plans and Philips objectives.
Developing and implementing regional regulatory strategies and processes to support the timely registration of, new products, major changes and life cycle management.
Coordinate with Regulatory Affairs Director International and with Q&R head APAC and and lead regulatory affairs specialists in the countries under the scope to ensure to ensure optimal, efficient and compliant registration.
Lead and drive regulatory activities in accordance with local and international requirements to ensure Philips on time products registration or life cycle management in the markets in scope of responsibility.
Responsible for Regulatory monitoring and analysis of new or updated local legislation and for assuring in-time registration in the local market (country).
Create with innovation teams a regulatory plan and a labelling plan (when needed) to ensure consistency and guidance to the market introduction projects.
Ensure product compliance by executing the regulatory plan and reviewing all relevant compliance evidence.
Identify potential regulatory approval risks based on regulations, standards, country-specific issues or other unique characteristics.
Recommend strategies to the business on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive implementation and resolution.
Represent Philips in local or regional standard- committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization,
Consult with product and solutions teams to ensure timely, effective and efficient transition to new requirements. Mentor and train others to effectively do the same.
Shares knowledge and is able to guide and mentor others about regulatory best practices and registration standards for regulatory approvals and post-market needs.
You will be part of :
the international regulatory management team with members in international/ regional markets.
To succeed in this role, you should have the following skills and experience:
Master degree (Engineering or Medical / biomedical background)
10 years of experience in Regulatory Affairs in APAC
Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must,
Experience in Project management within Regulatory Affairs is preferred,
FDA , TGA and EU MDD, CE marking experience is a plus,
RAPS Certified is a plus,
Strong communicative and stakeholder management skills,
Fluent in English. Additional language is a plus,
Strong leadership skills,
Organized, details oriented, decision making,
Business partner and account manager capabilities,
Influencing and consulting skills,
To be able to work in a constant changing environment,
Comfortable with business travelling up to 20% regionally
Act with Integrity,
Must be self-motivated
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .