embecta is a integral 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.
At embecta, we are committed to advancing care and improving lives.This is a Senior Regulatory Affairs Specialist role focused on bringing innovative medical devices to market across Mexico.
The position is hybrid, requiring on-site presence two days a week at our Mexico City office.What You'll DoLead end-to-end regulatory activities for new product registrations, renewals, and product changes.Develop and execute regulatory strategies aligned with business priorities.Ensure compliance with local regulatory requirements and embecta policies.Manage the lifecycle of product registrations, including working with distributors and third‐party partners.Act as a key liaison with health authorities and industry associations in Mexico.Support post‐market surveillance, vigilance reporting, and audit readiness.Provide regulatory risk assessments and strategic recommendations to internal stakeholders.Review and approve labeling,



promotional materials and advertising for compliance.Monitor the evolving regulatory landscape and proactively influence outcomes.What You BringUniversity Degree in Engineering, Pharmacy, Biology, or a related field.Minimum of 5 years of Regulatory Affairs experience within medical devices or healthcare industries.Advanced English (written and verbal) and native Spanish fluency.Strong communication and stakeholder influencing skills.Ability to plan, prioritize, and execute in a fast‐paced environment.Strategic thinking and regulatory problem‐solving capabilities.Collaborative mindset with a customer‐focused approach.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.
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📌 Senior Regulatory Affairs Specialist (Xico)
🏢 5510 Embecta De Mexico De R.L. De
📍 Xico