Lead I - Business Analysis

Who we are: Summary: Regulatory Affairs professional to drive complex global regulatory submissions for IVD and Medical Device portfolios . The role involves defining regulatory pathways, executing submissions across multiple geographies, coordinating with health authorities and Notified Bodies, mentoring junior team members, and partnering with cross-functional teams to support regulatory compliance and successful market access. The Opportunity: Role: Regulatory Affairs – IVD & Medical Devices Experience: 3–8 years Domain: IVD / Medical Devices Focus: Global Regulatory Submissions & Compliance Key Responsibilities 
 Lead the development and execution of global regulatory strategies for product registrations, renewals, and change controls across major markets. 
 Prepare, review, and submit regulatory dossiers in accordance with MDR, IVDR , and other regional regulatory frameworks across APAC, LATAM, EMEA, and other markets . 
 Manage the end-to-end regulatory submission lifecycle , including: 
 
 Gap analysis 
 Remediation activities 
 Application tracking 
 Regulatory query and response coordination 
 
 Partner with R&D, Quality, and Manufacturing teams to provide regulatory input into design and development documentation. 
 Coordinate directly with Notified Bodies and health authorities to address queries and facilitate timely regulatory approvals. 
 Maintain regulatory documentation and databases to support global portfolio maintenance . labeling reviews, product change assessments, and post-market compliance activities . submission preparation and document management workflows . on-the-job training and review of regulatory deliverables . What you need: Required Skills: IVDR, MDR, Compliance Management, Business Analysis Qualification: Life Sciences, Regulatory Affairs, Biomedical Engineering, or related degree Advanced degree preferred What we believe : We’re proud to embrace the same values that have shaped UST since the beginning. Since day one, we’ve been building enduring relationships and a culture of integrity. And today, it's those same values that are inspiring us to encourage innovation from everyone, to champion diversity and inclusion and to place people at the centre of everything we do. Humility: We will listen, learn, be empathetic and help selflessly in our interactions with everyone. Humanity: Through business, we will better the lives of those less fortunate than ourselves. Integrity: 
 We honour our commitments and act with responsibility in all our relationships. 
 
 Equal Employment Opportunity Statement 
 
 UST is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. 
 
 All employment decisions shall be made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. 
 UST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance. 
 
 • To support and promote the values of UST.

• Comply with all Company policies and procedures < Digital Transformation Solutions Company | UST< UST helps the world’s best organizations succeed through digital transformation, crafting disruptive solutions and strategies bringing our clients’ vision to life.<