At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.
Post : Sr. Regulatory Affairs Specialist (Clinical Informatics)
Job Description
• Through end-to-end regulatory processes, ensuring safe and effective products / solutions are brought to market, on time, and sustained throughout life cycle via compliant, innovative regulatory strategies.
• Compiling registration dossiers, 510(K)s and providing advice on submissions to Product teams.
• Provide critical input on regulatory risk assessments to support Business.
• Build proactive, strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities, etc.) to ensure that requirements are known early during strategy development, which enables fast market access with the current portfolio in connection with future innovations.
• Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips market organization.
Candidate Profile
• Minimum of a master’s degree (or equivalent), in a relevant field with a minimum of 8+ years of experience working in Regulatory Affairs within the medical device industry.
• Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Files/Design Dossier) and experienced in strategic relationships with external stakeholders (e.g., Industry Associations etc)
• Experience with Active devices (Class II/Class III devices including Hardware devices), SaMD, AI, digital health, cloud computing and associated development methodologies as well as lifecycle topics is preferable.
• Knowledge of MDD, MDR, IVDR, MedDev & MDCG’s, QMS standards, safety risk management, software development, cybersecurity and labeling standards, other applicable regulations, standards and application of them.
• Experienced in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.
• An excellent communicator and collaborator who can build and maintain cross-functional partnerships in support of business successes and self-directed with a strong work ethic and with an ability to work in a goal-oriented environment.
• An ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for solution.
Additional Information
Experience : 8+ years
Qualification : Minimum of a master’s degree (or equivalent)
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Informatics
End Date : 10th November 2024
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