embecta is a global diabetes care company that is leveraging its 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  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and X (http://twitter.com/embecta) .  **Why join us?** A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. Ensure timely registration of new products, plus maintenance of existing registrations, for Embecta Direct Entities and Distributor Markets, Lead the labelling & promotional material approval process and fulfil all regulatory compliance activities and responsibilities as required. + This position is responsible for managing and ensuring that the quality system compliance, requirements and the complaint management system are met per the relevant standards, corporate & region, and other relevant local regulation requirements. + To account for the assigned new registration & maintenance projects of Embecta Direct + 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 Direct Entities and Distributor Markets products + To monitor and analyse changes in regulatory environment trend, threats, and opportunities + To set up and be responsible for Embecta Direct Entities and Distributor Markets 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 embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.