Medical Device Regulatory Specialist

1 week ago

Bellary, Karnataka, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title

Quality Assurance Professional

We are seeking a Quality Assurance Professional to implement and maintain a Quality Management System (QMS) that ensures products meet quality, safety, and regulatory standards. The ideal candidate will have deep knowledge of global medical device regulations and standards, excellent problem-solving skills, and strong communication abilities.

  • Implement and maintain a QMS to ensure products meet quality, safety, and regulatory standards.
  • Identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
  • Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
  • Support the management of supplier quality and compliance.
  • Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.

Requirements:

  • Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
  • Problem-Solving & Attention to Detail: Crucial for interpreting regulations, documenting processes, and resolving issues.
  • Communication Skills: To coordinate with internal departments and external stakeholders.
  • Bachelor's Degree: In a relevant field such as engineering, life sciences, or a related technical discipline.
  • Experience: Previous experience in QA/RA within the medical device industry is an advantage.

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