Manager Quality Assurance & Regulatory Compliance Job in Abbott Laboratories

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.

Conduct/support India & South Asia Management Review to provide updates on adequacy and effectiveness of Quality Management system.

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 as per timelines defined in the procedure. Also monitor relevant trainings assigned to all employees with respect to their job functions in India

Create, review and approve all Pricing labels for marketed products prior to use for assigned products/projects

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

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.

Maintain up-to-date knowledge procedures and regulations

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 and Sales Reps and Distributors as needed

Regularly gets updated and self-trained with the latest regulations on Medical devices in the country

MINIMUM QUALIFICATIONS

Minimum Education

B.Sc. or B. Pharma with one core subject as Regulatory Affairs or bachelors degree in life science, clinical research studies or engineering. Advanced degree preferred. Understanding of regulatory affairs in medical devices/ pharmaceuticals environment.

Education Level

Major/Field of Study

B.Sc or B Pharma or bachelors degree in Life Sciences

Quality or Regulatory Affairs

MINIMUM WORK EXPERIENCE

Experience

Experience Details

6-8 years of experience

Experience in Quality / Regulatory Affairs Department.