Leader in Regulatory Compliance

24 hours ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Regulatory Compliance Leader

The Director of Quality and Regulatory Compliance will serve as an active member of the SAPAC region QRC leadership team. They will provide Regulatory & Quality Leadership for the region where Getinge is present, ensuring compliance with local quality management systems and product registration requirements.

This role reports to the Senior QRC Director, APAC and has dotted reporting to the Managing Director, SSU.

Key Responsibilities
  • Execute quality responsibilities according to applicable global sales quality management system, local quality management system of India, and other requirements (30% time)
  • Ensure post-market vigilance activities are executed on a timely manner in accordance with local and Corporate requirements (30% time)
  • Promote and implement strategic planning, including development and implementation of the QRC strategic plan (25% time)
  • Manage people, product registration, and ensure timely and compliant manner (15% time)
Required Skills and Qualifications
  • Strong leadership and communication skills
  • Resourceful and independent team player
  • Mature, pro-active working attitude and able to work under pressure
  • A team player and a self-starter with strong inter-personal and presentation skills
Supervision/Management of Others
  • Responsible for the development and management of QRC manager and specialist teams
  • Provide clear direction and keep the work group moving forward and focused on the right tasks
Internal and External Contacts/Relationships
  • Main contacts: Management team, QRC team in region, BA QRC teams, Sales department, Service department, Logistics department
  • Main external contacts: Central Drugs Standard Control Organization, Ministry of Health & Family Welfare, Bureau of Indian Standards, ISO certification body, Distributors


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