Senior Compliance Specialist

13 hours ago


Jamnagar, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000
Job Title:

Quality Assurance Specialist

Key Job Responsibilities:
  • Develop and maintain a comprehensive Quality Management System (QMS) that ensures conformity to quality, safety, and regulatory standards.
  • Evaluate and ensure compliance with relevant medical device regulations for market entry and ongoing regulatory adherence.
  • Manage technical documentation, regulatory submissions, quality agreements, and internal processes to guarantee consistency and accuracy.
  • Collaborate with design and development teams to provide QA/RA input and support, ensuring early identification and mitigation of potential compliance risks.
  • Participate in risk management activities throughout the product lifecycle to identify and mitigate potential hazards.
  • Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting to inform business decisions.
  • Oversee supplier quality and compliance initiatives.
  • Conduct regular internal audits and lead process improvement initiatives to optimize QMS operations and ensure continuous improvement.
Required Skills & Qualifications:
  • Regulatory Expertise: In-depth knowledge of global medical device regulations and industry standards.
  • Problem-Solving & Attention to Detail: Essential for effective interpretation, documentation, and issue resolution.
  • Communication Skills: Crucial for collaborating with cross-functional teams and external stakeholders.
  • Education: Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Experience: Prior experience in QA/RA within the medical device industry is highly desirable.


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