descrizione del lavoro

embecta, formerly part of BD, is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com.

Major Accountabilities
To account for the assigned new registration & maintenance projects of Embecta South Asia’s products
To develop and execute transition strategies and meet the compliance timelines
To ensure regulatory compliance to secure business continuity –certificates, labeling, approval variation, annual reporting, product renewal, complaints, Adverse Event Reporting, Field Actions and Recall in accordance with country and global company regulatory requirements.
To lead internal label review & approval process and promotional material approval process for Embecta South Asia’s products
To monitor and analyse changes in regulatory environment trend, threats, and opportunities
To set up and be responsible for Embecta South Asia’s QMS

To be responsible for interface and coordination with the local regulatory representatives for post-market surveillance reporting, and any local regulatory and quality auditing activities.
To comply with all legal, regulatory, and ethical business requirements in executing the assigned roles and responsibilities as defined in the local regulation and the Corporate procedure

Ideal Background
Education
Minimum: B.A degree in Pharmaceutical,Engineering, Chemistry, Life Science or other relevant subject matter
Experience
5 years of handling RA QA in Medical Device Companies

Preferred to have experiences in Sri Lanka and Bangladesh

Location : Delhi India