Website Philips
Improving Lives Through Meaningful Innovation
Join Philips – Improving Lives Through Meaningful Innovation
About Philips
At Philips, every life matters. As a global leader in health technology, we are committed to enhancing health and well-being through groundbreaking innovation. For over 130 years, we have been developing solutions that empower healthcare providers and transform patient care. Headquartered in the Netherlands and operating in more than 100 countries, our expertise spans Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Connected Care, Sleep & Respiratory Care, and Personal Health.
We are seeking passionate individuals to join us and bring our mission to life.
Position:
Senior Regulatory Affairs Specialist (Clinical Informatics)
Role Overview:
In this role, you will drive regulatory activities that ensure the timely delivery of safe, effective products and solutions to the market. With a focus on innovation, compliance, and lifecycle management, you will collaborate with cross-functional teams to support product teams and regulatory submissions, ensuring seamless market access globally.
Key Responsibilities:
Develop and execute end-to-end regulatory strategies to bring innovative products to market in a compliant manner.
Prepare and submit registration dossiers, including 510(k) submissions, and provide regulatory guidance to product teams.
Offer strategic input on regulatory risks to support business objectives.
Foster strong relationships with external stakeholders, including Notified Bodies, FDA, and Competent Authorities, to ensure early alignment with market access requirements.
Lead cross-functional collaboration between Regulatory Affairs, R&D, Product Management, Quality, Clinical Affairs, and regional Regulatory teams to streamline product strategies and compliance.
Candidate Profile:
Education: Master’s degree (or equivalent) in a relevant field.
Experience: Minimum 8+ years of Regulatory Affairs experience in the medical device industry.
Expertise:
Extensive knowledge in preparing FDA submissions (Pre-submissions, IDE, 510(k), Technical Files).
Proven ability to manage relationships with external stakeholders, including regulatory bodies and industry associations.
Familiarity with Class II and III devices, SaMD, AI, cloud computing, and related development methodologies.
Strong understanding of MDD, MDR, IVDR, MedDev, MDCG guidelines, QMS standards, and other regulatory frameworks.
Knowledge in cybersecurity, software development, labeling standards, and safety risk management.
Skills:
Experienced in global regulatory strategy formulation and compliance to support product market access.
Effective communicator with cross-functional collaboration skills.
Strong problem-solving abilities with insight into business trends and operational processes.
Additional Information:
Experience Required: 8+ years
Education Qualification: Master’s degree (or equivalent)
Location: Bangalore
Industry: Healthcare/Pharma/Clinical Research
Functional Area: Clinical Informatics
Application Deadline: November 10, 2024
Why Join Philips?
At Philips, we foster a culture where purpose-driven innovation thrives. You will be part of a diverse team, working on solutions that make a real difference in people’s lives. If you are passionate about healthcare technology and regulatory affairs, we invite you to join us on this journey.
Apply today to be a part of a future where every life is valued and healthcare continues to evolve.
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