Senior Medical Device Compliance Specialist

2 days ago

Chennai, Tamil Nadu, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

Medical Device R&D Roles

We are seeking experienced professionals to drive compliance activities and lead successful QMS processes at a medical device facility.

The selected candidates will be responsible for various roles including Design Quality, Mechanical Engineering, Electrical & Electronics Engineering, and Software Engineering.

Key Responsibilities:

  • Create a quality culture by driving compliance activities around specific products, sites, or regions.
  • Experience in medical device QMS processes.
  • Organize, drive rigorous compliance of, and lead successful QMS processes at a medical device facility.
  • Communicate complex messages and negotiate with others to adopt different points of view.
  • Use high-level judgment to make decisions and handle complex tasks or problems impacting site compliance.

Required Skills and Qualifications:

  • Bachelor's Degree. Experience in establishing Design Quality Control, Assurance, Regulatory Affairs teams & competence development from scratch within a regulated industry.
  • Effective communication of technical information in English (written and oral).
  • Understanding and interpretation of Risk Management, Design Controls, Standards & Regulations, CDSCO, FDA, MDSAP, etc., for Class 2 and Class 3 devices.

Benefits and Opportunities:

  • Opportunity to work on various medical device projects.
  • Chance to develop skills in design quality, mechanical engineering, electrical & electronics engineering, and software engineering.

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