To assist in new products registration and license renewal compliance to local regulations, as well as GMP, CE and ISO 13485 requirement.
To assist the QA/RA team and ensure quality and good standard operating procedures within the company.
Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product lifecycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment.
Oversee the maintenance of product quality and compliance through the Quality Assurance and Quality Control functions as well as management of the Quality Management System and compliance processes.
Support Commercial Department in business development such as product evaluation and pre-launch activities.
Keep abreast of international legislation and guidelines of the current product line in India.
Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements.
Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements
Provide product-specific Regulatory strategies to mitigate risk; works in conjunction with production & QA team to provide advice on process and labeling changes.
Review of SOPs, BPRs, specifications and change control to ensure compliance.
Note: Preference Male candidates only
HR Name: Neelam Gupta
Company: Aegis Lifesciences