Philips
Description
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
Responsibilities
- Advise internal stakeholders regarding current/pending guidance, regulations, agency/industry initiatives especially around software including AI, and machine learning to ensure regulatory strategy is in alignment with company objectives.
- Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy.
- Responsible for product registration submissions/approvals for the US, Canada, EU and selected worldwide locations.
- Review and approve advertising promotional items and labeling for regulatory compliance.
- Mentor other regulatory affairs personnel within HPM regulatory.
Qualifications
- Bachelor's degree in Regulatory Affairs or a science related field preferred or equivalent medical device industry experience.
- Experience with FDA 510K submissions.
- Experience with SaMD and familiarity with artificial intelligence and machine learning preferred.
- RAPs RAC strongly preferred.
- Modular software architecture experience preferred.
- Agile software development skillset is a plus.
- Cybersecurity experience is also a plus.
