Regulatory Affairs

2 days ago

Riyadh, Saudi Arabia Radiometer Full time

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The **Regulatory Affair and Quality Assurance Specialist **at Radiometer Saudi Arabia will be responsible for **regulatory life cycle management and supporting different RA/QA projects related to Radiometer solutions for blood sampling, blood gas analysis, transcutaneous monitoring, POC immunoassay testing, and related IT management systems. The incumbent will have the opportunity to work with regulatory, quality involving technical complexity in a truly global organization.**

This position is part of the **Regulatory & Quality Affairs** located in **Riyadh** and will be **working in** **a hybrid work set-up**. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the local **RA/QA Team** at Radiometer Saudi Arabia. Your area of responsibility will be to **ensure market approvals and maintain existing product licenses with quality assurance, such as local importer responsibility - this requires special knowledge within In Vitro Diagnostics - and Medical Device legislation**. If you thrive in **an independent role** and want to work to build a world-class RA/QA organization—read on.

**In this role, you will have the opportunity to**:

- Responsible for products registration, renewals, and ensuring approvals via GHAD systems and other SFDA systems, including reimbursement follow up if any.
- Responsible for the post-market surveillance of medical devices for all related reports in accordance with the regulatory agency guidelines.
- Facilitates all related technical information and applicable documentation for licensing of products.
- Manages vigilance activities.
- Works with global RA (Regulatory Affairs) teams on any changes and assessments that impact In-Vitro Diagnostics and Medical Devices across local regulations.
- Implements and maintains the Quality Management System (QMS).
- Be the RA/QA expert to advise various BUs and to translate and implement regulatory knowledge to Radiometer products and to communicate the quality policy, quality objectives and quality effectiveness to the organization.

**The essential requirements of the job include**:

- University graduation in biomedical engineering, pharmacy, or pharmacy science.
- Minimum 4 years of experience in Regulatory Affairs and Quality Assurance within In-vitro diagnostic medical devices and medical devices legislation (IVD, MD).
- Must have SFDA Experience.
- Experience with International Quality and Regulatory Standards (e.g., ISO 9001, ISO 13485, Medical Device Regulations).
- Good presentation and communication skills and scientific approach to find and digest the necessary information to support each regulatory task.

**It would be a plus if you also possess previous experience in**:

- Working with compiling regulatory files and achieving approvals (Class 1~3, both MD and IVD registration).
- Medical Device Single Audit Program (MDSAP).
- Hybrid Work Set-up:_

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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