Lead I - Business Analysis

• *Role description** ***Who we are:***

At UST, we help the world’s best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co\-create lasting change. Together, with over 30,000 employees in 30\+ countries, we build for boundless impact—touching billions of lives in the process. Visit us at .

• *Summary:**

UST is looking for an experienced **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**.
• Guide regional teams on regulatory requirements, submission formats, and timelines to ensure consistency in execution.
• Support **labeling reviews, product change assessments, and post\-market compliance activities**.
• Identify opportunities to improve **submission preparation and document management workflows**.
• Mentor regulatory specialists through **on\-the\-job training and review of regulatory deliverables**.
• Maintain accurate, complete, and up\-to\-date regulatory documentation and records.
• Ensure appropriate documentation practices are followed in accordance with applicable regulatory standards.

• *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.

• *Skills**

IVDR, MDR, Compliance Management, Business Analysis

• *About UST**

UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world’s best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future\-proof philosophy, UST embeds innovation and agility into their clients’ organizations. With over 30,000 employees in 30 countries, UST builds for boundless impact—touching billions of lives in the process.