Abbott Manager QA & RA Compliance in New Delhi, India
Support in developing, implementing, assuring and monitoring the Quality and Regulatory Compliance strategies of the company.
Support evaluation of adequacy and compliance of systems, operations and practices against regulations and company documentation.
Closely work with Management Representative for India to provide updates on Quality and Compliance issues and also support in India Management Review Meetings with timely inputs
Support management of the complaint handling system and prepare analysis report for the management review
Support Field Safety Corrective Action / Recall, Corrective & Preventive Actions (CAPA)& Stop Shipment
Support Internal & External Quality & Compliance Audits
Support management of ATMS trainings and assign trainings to all new employees within 14 days of joining. Also monitor relevant trainings assigned to all employees with respect to their job functions in India
Create, review and approve all labelling for marketed products prior to use for assigned products/projects
Lead all label and relabeling activities/negotiations and executions. Work with Labelling team to be compliant to India Specific labels as per local regulation
Review and approve advertising, promotional items and labelling for regulatory compliance
Tracks Quality issues through to closure including reviewing corrective action taken
Provide feedback on the new procedures (SOP or DOP) being developed by International quality & compliance team
Prepare and submit all PSURS, PMS reports, Adverse Event Reports and other safety reports to the regulators
Identify major regulatory and compliance risk and threats to the overall business in India and South Asia and update the management regarding the same.
Working cohesively with all functions at local and global level on requirements for Quality and Regulatory Compliance.
Develop and monitor programs to ensure compliance with related acts and regulations in conformance with industry standards.
Collaborate with senior management team to review and approve documentation provided by various functions including but not limited to working directly marketing, sales and supply chain.
Support Sales team with regards to any regulatory documents required for tender approval
Manage Product Release Approval (PRA) Release post approvals and India Specific labels are released
Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications
Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department
Provide input into development of regulatory and quality systems, SOPs for the efficient operation of the department and inter-department activities.
Provide training to the regulatory staff and Sales Reps and Distributors as needed
Regularly gets updated and self-trained with the latest regulations on Medical devices in the country
Networking and Liasioning with the Regulatory agencies both at centre and state level
India > New Delhi : New Friends Colony
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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