Medical Device Regulatory Affairs Manager

Key Responsibilities :

• Experiences into testing and certification of Active Medical devices for various 60601 basic and product standards
• Knowledge on ISO 13485, ISO 14971, etc
• Responsible to handle the Active Medical Device business segment of EnE for complete Indian region
• Responsible to develop the business of Active medical devices and sustain the business
• Responsible to drive the challenging targets with Techno-commercial knowledge
• Should work closely with Laboratory team to develop test methods for Active Medical devices
• Should work closely with Sales and Marketing teams
• Responsible to build his strong team across India
• Having experience in handling P&L responsibilities
• Should possess high attributions in winning culture
• Having responsibilities in handling a team of 5-10 experts
• Should have a strong knowledge on Medical Device testing market in India
• Having in-depth knowledge of Active Medical equipment’s requirements for various countries
• Should have a strong command on Active medical device regulations for India & Global
• Should have a strong presentation, communication and interpersonal skills

Education & Work Experiences :