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About Company

The Medical Device Design Assurance Engineer will focus on accelerating technical deliverables related to medical device design and development. This role also supports sustaining engineering activities and provides support to the Quality organization for quality initiatives. Responsibilities include developing and implementing methods and procedures for process control, process improvement, testing, and inspection to ensure products are free of flaws and function as designed.

Position Name :

Regulatory Affairs Specialist

Organization :

Molex

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

5+ years

Salary:

45,000 - 115,000 /month

Location:

Bangalore

Phillips Medisize, part of Molex, specializes 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. Our new Global Innovation and Development center in Bangalore, India, is 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 packages and support the 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, and manufacturing teams.

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