Director Quality and Regualtory Affairs, Med Devices, Bangalore

1.Maintains the effectiveness of the QMS including management review, CAPA, internal audit, document control, change management, training, supplier quality, risk management, complaint handling, nonconforming product, validation, and post-market surveillance.

2.Develops the product/organizational regulatory and quality assurance strategies.

3.Develops and oversees 510k submissions, technical files, and post market surveillance.

4.Ensures quality planning throughout product realization including APQP, PFMEA, Control Plans, process validation, software validation, statistical techniques, and process monitoring where applicable.

5.Evaluates and provides for audits, corrective actions, and compliance verification of internal and external quality systems and their functions.

6.Provides the quality engineering function assuring that products meet their intended use through risk assessment, control plans, product specification, continuous evaluation, and data analysis.

7.Represents the company as the Quality and Regulatory expert internally and externally.

8.Provides executive leadership during customer, notified body, FDA and other regulatory inspections, including response development, remediation planning, and effectiveness verification.

9.Acts as the quality/regulatory representative on new product introduction teams.