Senior Associate Quality Assurance & Regulatory Affairs Job in Niramai

NIRAMAI Health Analytix is looking for a dynamic professional with strong interest in quality assurance and regulatory affairs to assist in implementing quality management system and regulatory strategies for maintaining compliance with established standards like ISO 13485, ISO 14971, IEC 62304 & 82304, US FDA and CE Marking. Incumbent would focus on Medical device regulation, SaMD (Software As Medical Device).

Primary roles & responsibilities:

• Coordinate with respective teams including external consultants to implement quality system and regulatory procedures and initiatives
• Organize and maintain documents and records on file and electronically, manage formal change controls
• Maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and guidelines
• Plan and manage periodic internal audits necessary to monitor QMS; Manage non-conformance, corrective action preventive actions and deviation.
• Provide guidance regarding best practices and continuous improvement
• Establish effective processes for handling CAPA resulting from customer complaints/feedback
• Review device labelling and advertising materials for compliance with regulations; analyze and recommend appropriate changes.
• Conduct required QMS training to all employees and monitor the training coverage and effectiveness

Requirements for the role :

• Hands-on experience in Medical device regulation, SaMD ( Software As Medical Device) preferable.
• Strong understanding of the quality system requirements for both CE and FDA
• Thorough knowledge of product development process, design control
• Ability to work with various stakeholders within and outside organization and positively influence team spirit
• Result orientation and willingness to take ownership
• Attention to details
• Excellent communication and interpersonal skills
• Experience: Minimum 3-4 years of experience in Medical device regulation
• Education: Bachelor s degree in science/biomedical/engineering

About NIRAMAI Health Analytix Pvt Ltd

NIRAMAI is a health technology startup founded in July 2016. Their key offering is a Novel Cancer Detection Solution for Hospitals and Diagnostic centers and enable mass screening in rural areas. NIRAMAI is a Series A funded company from popular Indian investors such as Pi Ventures, Axilor, Ankur Capital, Binny Bansal and international investors such as Dream Incubator (Japan) , BeeNext (Singapore) and 500 Startups(US). NIRAMAI has won many national and international awards and recognitions. It is the only Indian company listed on CBInsights AI 100 2019 list, the Top 100 AI companies in the world across all domains. For more details, see https://www.niramai.com