Regulatory Affairs Specialist

About the job

Your Job

The Medical Device Design Assurance Engineer will focus on accelerating technical deliverables related to medical device desig½n and development. The Medical Device Design Assurance Engineer will also support sustaining engineering activities and provide support to the Quality organization for quality initiatives. Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.

Our Team

Phillips Medisize is an expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Phillips Medisize is a part of Molex. We have opened a new Global Innovation and Development center in Bangalore, India and expected to grow in the Asian region.

What You Will Do

• Participate in the development of regulatory submission and approval strategy in multiple countries.
• Maintain awareness and understanding of new and existing regulatory requirements.
• Support identification of applicable regulatory requirements, their impact and how to interpret them.
• Execute regulatory strategy by applying regulatory requirements and generating documentation.
• Review and ensure compliance of the technical documentation.
• Assemble regulatory submission package and support submission process.
• Interact with customers and regulatory authorities to ensure regulatory approval/clearance.
• Maintain technical documentation to ensure continuous product conformity and approval.
• Contribute to alignment between development, risk, usability, clinical, testing manufacturing team.

Who You Are (Basic Qualifications)

• Bachelor's degree or better in life science or engineering.
• 5+ years of proven experience in quality or regulatory role in the medical device industry.
• Deep understand of the Medical Device Regulation (EU) 2017/745, and medical device development standards such as ISO 13485, ISO 14971.
• Good understand of technical and injector specific standards, such as ISO 11608.
• Experience in preparing technical documentation intended to be use for a submission in Europe, 510(k) submissions, Device Master File (MAF), and foreign registration.
• Excellent written and verbal communication skills in English.

Please use the below link for job application and quicker response.

https://lifelancer.com/jobs/view/168ef893db254de4015b73520468b77f