Quality Assurance and Qualified Lead Auditor for ISO 13485 and ISO 9001 With expertise in to register the medical devices approvals in India from CDSO and also have basic under sting of the other countries regarding medical device regulation and FDA Guidelines
Prior approval in registration of the medical devices in India with CDSCO Authority
Sound experience in working with Startup companies and setting up the Regulatory Affairs department.
In Depth knowledge of various testing requirement of medical devices, Technical File / Design Dossier preparation, risk management, implementation of Quality Management System (ISO 13485 ISO 9001) etc. Able to help companies to design plant that meets international requirements.
Have experience of dealing with DCGI (India) office for issues related to Imports, New Registrations, Clinical Trials Approvals etc.
Specialities for medical device Regulatory Affairs, Medical Device Registration, CE Marking, Quality Management System (ISO 13485 ISO 9001), Market Strategies, Design Dossier Preparation, Risk Management, Medical Device Testing
Lead, provide strategy and guidance, and coordinate the Regulatory Affairs initiatives within a Product group in the region to define the regulatory compliance for existing and new products marketed in the region and destine for export
Provide thought leadership in Regulatory Affairs area in the region
Understand, anticipate, and interpret regulatory change
Develop and coordinate regulatory positions, requirements, and processes by working with commercial teams and Functional units (FUs), key customers, and external regulatory agencies
Partner with PSQR colleagues to assess and implement programs and processes that enable Regulatory compliance
Develop strong Regulatory Affairs coordination and connections across product groups and regions to ensure their continuous development which enables the capacity for executing Regulatory compliance related activities
Minimum Qualifications
Science Degree (chemical or agricultural focus areas) or equivalent experience
Experienced of dealing with government and trade association Technical Skills
Demonstrated knowledge of technical in Bio-industries, chemical and or cosmetics
Ability to provide leadership and coordination of quality efforts across the team
Organize work and projects effectively from planning through execution
Maintain high profile, builds long-term relationships and network of useful contacts
