Quality & Regulatory Compliance Director

Job Overview :

The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He / She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the IN country’s QA & RA requirements and is also expected to lead activities to bridge gaps in the QMS & product registration requirements. Managing and insuring proper filing of all required compliance documents, submissions, registrations, etc to ensuring products supplied in India meet the requirements of the Medical Devices Rules 2017.

This role will have a solid line reporting to Senior QRC Director, APAC & dotted reporting to the Managing Director, IN SSU.

Job Responsibilities and Essential Duties :

• A list of the main responsibilities and percentage of time spent in each responsibility or group of responsibilities :
• (30%) Execute the job responsibilities according to applicable Global Sales Quality Management System (GS QMS), Local Quality Management System of India, and other requirements
• (30%) Ensure Post Market Vigilance activities are executed on a timely manner according with local and Getinge Corporate requirements
• (25%) People Leadership
• (15%) Product Registration on a timely & compliance manner

Strategic Planning

Required Knowledge, Skills and Abilities

Supervision / Management of Others

Internal and External Contacts / Relationships

o Management team

o QRC team in region

o BA QRC teams

o Sales department

o Service department

o Logistics department

o Central Drugs Standard Control Organization, Ministry of Health & Family Welfare

o ISO certification body (TUV SUD Europe)

o Distributors

Environmental / Safety / Physical Work Conditions

Minimum Requirements :