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Location: Bangalore, India
Industry Type: Pharma / Healthcare / Clinical Research
Functional Area: Clinical Informatics
Application Deadline: November 10, 2024

About Philips: 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. With over 130 years of experience, our advanced technologies and deep clinical insights are transforming healthcare across the globe. We operate in more than 100 countries, focusing on areas such as Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Connected Care, Sleep & Respiratory Care, and Personal Health.

Position Overview: We are seeking a Sr. Regulatory Affairs Specialist to join our Clinical Informatics team. In this role, you will play a crucial part in ensuring that our products and solutions are brought to market safely and effectively. You will develop and implement innovative regulatory strategies to support our product lifecycle and compliance needs.

Key Responsibilities:

  • Oversee end-to-end regulatory processes to ensure timely market access and product sustainability.
  • Compile registration dossiers and 510(k) submissions, providing guidance to product teams.
  • Conduct regulatory risk assessments and provide critical insights to support business objectives.
  • Build proactive, strategic relationships with external stakeholders (e.g., Notified Bodies, FDA) to facilitate early understanding of regulatory requirements.
  • Foster strong cross-functional partnerships with R&D, Product Management, Quality, Clinical Affairs, and local Regulatory Affairs teams.

Candidate Profile:

  • Education: Master’s degree (or equivalent) in a relevant field.
  • Experience: Minimum of 8+ years in Regulatory Affairs within the medical device industry.
  • Expertise: Extensive knowledge of FDA submissions (Pre-submissions, IDE, 510(k), Technical Files/Design Dossier) and experience managing strategic relationships with external stakeholders.
  • Technical Skills: Experience with Class II/Class III devices, SaMD, AI, digital health, and cloud computing; familiarity with MDD, MDR, IVDR, QMS standards, and safety risk management.
  • Strategic Thinking: Proven ability to formulate and implement global regulatory strategies for compliance with worldwide regulations.
  • Communication: Excellent communicator and collaborator with a strong work ethic and goal-oriented mindset.
  • Analytical Skills: Ability to analyze diverse issues and data to evaluate factors impacting business trends.

Join Us: If you’re passionate about improving healthcare through innovative solutions and have the experience we’re looking for, we invite you to apply for this exciting opportunity at Philips.

How to Apply: Please submit your application by November 10, 2024. We look forward to hearing from you!

Application link

Philips Hiring Sr. Regulatory Affairs Specialist