- Chance to lead QARA for an established Med Devices MNC

- Chance to be a key contributor in a fast growing organisation

About Our Client The organisation is a US based Medical Devices MNC

- 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.

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

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

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

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

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

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

- Provides executive leadership during customer, notified body, FDA and other regulatory inspections, including response development, remediation planning,



and effectiveness verification.

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

The Successful Applicant

- Good organisational and leadership skills.Over 10 plus years experience (5 years in a management capacity) related to implementation of Quality principles, Product sterilization, FDA 21 CFR Part 820/QMSR transition knowledge, ISO 13485:2016, ISO 14971 including Design Control, process validation, software validation, supplier quality, design transfer, contract manufacturing, data integrity, CAPA/Compliant processes, Clinical, Environmental, Document Control systems and global regulatory requirements.

- Must have a good understanding of blueprint reading, geometric dimensioning/tolerancing practices, and statistical quality concepts. Be familiar with design of experiment practices. Must have good supervisory experience, excellent communication, and interpersonal skills. Must be detail oriented, organized, flexible, and can practically apply the quality sciences as a value-add to the organization.

What's on Offer

- An chance to lead in the life sciences sector.

- Work with cutting-edge medical technology.

- Be part of a company focused on compliance and quality.

If this role matches your skills, consider applying.

Contact

Quote job ref: JN-082026-7087186

📌 Director Quality and Regualtory Affairs, Med Devices, Bangalore (Bangalore East)
🏢 Michael Page
📍 Bangalore East