Senior Medical Device Professional

19 hours ago


Thiruvananthapuram, Kerala, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 2,50,00,000

Job Title: Senior Medical Device Professional

About the Role

This role requires a seasoned professional with a minimum of 10 years of experience in the medical device industry, preferably in healthcare products or related activities.

The ideal candidate will have a solid understanding of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their application. Additionally, they should have experience with Risk Management EN ISO 14971 and knowledge of sterilization processes.

A team player with excellent communication skills and a strong work ethic is required to collaborate effectively with cross-functional teams.

  • Good knowledge of regulatory affairs and quality management principles.
  • Experience in research and development, manufacturing, or quality assurance is highly preferred.
Key Responsibilities
  • Evaluate and assess medical devices for compliance with regulatory requirements.
  • Develop and implement quality management systems to ensure adherence to industry standards.
  • Collaborate with cross-functional teams to identify and mitigate risks associated with medical device development and manufacture.

The successful candidate will be a self-motivated individual with excellent problem-solving skills and a passion for improving patient outcomes through innovative medical device solutions.



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