Senior Regulatory Affairs Specialist

2 weeks ago


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

Seeking a seasoned professional to oversee quality assurance and regulatory affairs in the Medical Device Industry.

Key Responsibilities:
  • Maintain Compliance: Adhere to ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Regulatory Coordination: Collaborate with local authorities to obtain necessary permissions and approvals.
  • Risk Management: Oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices.
  • Regulatory Submissions: Manage submissions and ensure timely approvals.
  • CAPA and Audits: Handle Corrective and Preventive Actions to maintain compliance and continuous improvement, while supporting audits and inspections.

The ideal candidate will have a strong understanding of quality systems and regulatory frameworks, hands-on experience with regulatory submissions, PMS, and risk management, excellent knowledge of GMP, GDP, and ISO 13485 standards, and strong communication, documentation, and coordination skills.

Requirements:
  • Quality Systems: Strong understanding of ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Regulatory Frameworks: Knowledge of regulatory frameworks for medical devices.
  • Regulatory Submissions: Hands-on experience with regulatory submissions.
  • PMS and Risk Management: Experience with post-market surveillance and risk management.
  • Communication Skills: Excellent communication, documentation, and coordination skills.


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