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Senior Regulatory Affairs Leader
2 months ago
Position Overview:
The Senior Regulatory Affairs Leader will be pivotal within the Clinical Informatics division at Philips International, overseeing regulatory initiatives for our Disease Management Solution offerings. This role is essential in shaping our global regulatory strategy and ensuring market access, ultimately enhancing patient outcomes worldwide.
Key Responsibilities:
- Directing project teams to deliver comprehensive regulatory input and outputs for new product launches and modifications globally.
- Ensuring that safe and effective products are introduced to the market promptly through innovative regulatory strategies.
- Providing essential insights on regulatory risk assessments to aid in portfolio decision-making.
- Fostering proactive and strategic relationships with external stakeholders, including regulatory bodies, to streamline market access for current and future innovations.
- Developing FDA submission strategies for our product range and guiding cross-functional teams in the preparation of 510(k) submissions.
- Facilitating strong collaboration between Regulatory Affairs and key stakeholders across R&D, Marketing, Quality, Clinical Affairs, and local regulatory teams.
Qualifications:
- A minimum of 10 years of experience in FDA-regulated medical device or health technology sectors, with a strong background in preparing 510(k)s, PMAs, and other regulatory submissions.
- At least 5 years of experience leading product development teams to meet registration requirements effectively.
- In-depth knowledge of MDD/MDR, FDA QSRs, and applicable medical device regulations, particularly for the EMEA market.
- Experience with Advanced Visualization Software as a Medical Device (SaMD) is highly desirable.
- Proven ability to build strategic relationships with external regulatory stakeholders.
- Strong communication and collaboration skills to maintain effective partnerships across various functions.
- A Master's degree in Regulatory Affairs or a related Life Sciences field is required.
About Philips International:
Philips is a global leader in health technology, dedicated to improving health and well-being through innovative solutions. We believe in the importance of every individual and strive to ensure that quality healthcare is accessible to all. Join us in our mission to enhance lives through meaningful innovation.
