Regulatory Affairs
2 weeks ago
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.
-
Regulatory Affairs Manager
4 weeks ago
Riyadh, Saudi Arabia Kinetic Full timeA reputable and well-established pharmaceutical company is actively recruiting a **Regulatory Affairs Manager **to be based in **Riyadh, KSA**. This role will be working under RA Department and will be supporting local regulatory activities in Saudi Market. **The main responsibilities will include but not limited to**: - Review all regulatory submission...
-
Regulatory Affairs Supervisor
4 weeks ago
Riyadh, Saudi Arabia Almarai Full timeRegulatory Affairs Supervisor| Riyadh, Saudi Arabia **The Company**: An aggressive expansion program together with acquisitions in new vertical markets have created an exciting opportunity to join a dynamic multinational team dedicated to furthering growth plans for the group. **About the Role**: The Regulatory Affairs Supervisor is responsible to...
-
Riyadh, Ar Riyāḑ, Saudi Arabia Philips Full timeJob TitleRegulatory Affairs Manager, Hospital Patient Monitoring METAJob DescriptionJob title:Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.You are responsible for Create regulatory awareness level as determined within the organization. Supports implementation of simplified yet robust...
-
Riyadh, Saudi Arabia Philips Full timeJob TitleRegulatory Affairs Manager, Hospital Patient Monitoring METAJob DescriptionJob title:Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.You are responsible forCreate regulatory awareness level as determined within the organization.Supports implementation of simplified yet robust...
-
Regulatory Affairs Executive
3 weeks ago
Riyadh, Saudi Arabia Jamjoom Pharma Full timeCompile and submit, in a timely manner, regulatory documents according to regulatory requirements and regular follow up on the submitted files.Ensure timely submissions as well tightly manage deficiency responses.Work with market regulatory manager to develop a detailed understanding of regulatory guidelines and technical requirements in assigned...
-
Regulatory Affairs Executive
3 weeks ago
Riyadh, Saudi Arabia Jamjoom Pharma Full timeCompile and submit, in a timelymanner, regulatory documents according to regulatory requirementsand regular follow up on the submittedfiles.Ensure timely submissions as welltightly manage deficiency responses.Work withmarket regulatory manager to develop a detailed understanding ofregulatory guidelines and technical requirements in assignedcountries.Work...
-
Director of Regulatory Affairs
3 weeks ago
Riyadh, Saudi Arabia Life Sciences Recruitment Full time• In alignment with the Hiring Manager, is responsible for developing and implementing regulatory strategic plans for product registration and lifecycle management.• Lead the preparation of regulatory submissions including New Drug Submissions (NDSs).• Provide regulatory inputs and guidance to responses to EMA queries in relation to clinical...
-
Regulatory Affairs Executive
4 weeks ago
Riyadh, Saudi Arabia Jamjoom pharma Full timeJamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the...
-
Director of Regulatory Affairs
4 weeks ago
Riyadh, Saudi Arabia Life Sciences Recruitment Full time• In alignment with the HiringManager, is responsible for developing and implementing regulatorystrategic plans for product registration and lifecyclemanagement.• Lead the preparation ofregulatory submissions including New Drug Submissions(NDSs).• Provide regulatory inputs andguidance to responses to EMA queries in relation to clinicalefficacy and...
-
Regional Regulatory Affairs Specialist
3 weeks ago
Riyadh, Saudi Arabia Dexcom Full timeRecommends changes for labelling , manufacturing, marketing and clinical protocol for regulatory compliance.Monitors and improves tracking/control systems.Keeps abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Recommends strategies for earliest possible approvals of clinical trials applications.
-
Regional Regulatory Affairs Specialist
3 weeks ago
Riyadh, Saudi Arabia Dexcom Full timeRecommends changes for labelling ,manufacturing, marketing and clinical protocol for regulatorycompliance.Monitors and improvestracking/control systems.Keeps abreast ofregulatory procedures and changes.May directinteraction with regulatory agencies on definedmatters.Recommends strategies for earliestpossible approvals of clinical trialsapplications.
-
Regulatory Affairs Specialist
2 weeks ago
Riyadh, Saudi Arabia Cepheid Full timeIdentifies information sources andresources for local regulations.Collects andcoordinates information on regulatory requirements for in vitrodiagnostic devices, quality, preclinical and clinical data to meetapplicable regulations.Assist in deviceregistration activities - agency communication; registrationrequirements; participation in submission...
-
Regulatory Affairs Specialist
2 weeks ago
Riyadh, Saudi Arabia Cepheid Full timeIdentifies information sources and resources for local regulations.Collects and coordinates information on regulatory requirements for in vitro diagnostic devices, quality, preclinical and clinical data to meet applicable regulations.Assist in device registration activities - agency communication; registration requirements; participation in submission...
-
Regulatory Affairs Quality Assurance Specialist
4 weeks ago
Riyadh, Saudi Arabia Radiometer Full timeResponsible for productsregistration, renewals, and ensuring approvals via GHAD systems andother SFDA systems, including reimbursement follow up ifany.Responsible for the post-marketsurveillance of medical devices for all related reports inaccordance with the regulatory agencyguidelines.Facilitates all related technicalinformation and applicable...
-
Regulatory Affairs Quality Assurance Specialist
3 weeks ago
Riyadh, Saudi Arabia Radiometer Full timeResponsible 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...
-
Senior Public Affairs Manager
7 days ago
Riyadh, Saudi Arabia Tencent Full timeWork Mode: Onsite **Responsibilities**: As part of a critical MENA leadership team for minimum 5 years with 10 to 15 years collective experience in working in Saudi Arabia, you must show a broad appreciation of all aspects of publishing operations and Business development in mobile gaming to achieve Tencent’s goals in coordination with different...
-
Senior Government Affairs
4 weeks ago
Riyadh, Saudi Arabia Tencent Full timeWork Mode: Onsite **Responsibilities**: - [Company Introduction]_ Tencent is a world-leading internet and technology company that develops innovative products and services to improve the quality of life of people around the world. Founded in 1998 with its headquarters in Shenzhen China, our guiding principle is to use technology for good. We are not only...
-
Director
3 weeks ago
Riyadh, Saudi Arabia Biocon Biologics Full timeideal candidate for EU regulatory affairs should haveProven EU regulatory affairs experienceExcellent leadership and communication skills,Negotiation & liaising experience with EU FDA.Works with Biocon Biologics head of RA to derive the global development strategy partnering with GRL (Global Regulatory Lead).
-
Chief Medical Officer
4 weeks ago
Riyadh, Saudi Arabia Apsida Life Science Full timeProvide strategic leadership anddirection for all medical affairs activities, including clinicaldevelopment, regulatory affairs, and pharmacovigilance for a Phase2 ALS programEstablish and nurturecollaborative partnerships with key stakeholders, including,regulatory agencies, and clinical researchorganizations.
-
Chief Medical Officer
3 weeks ago
Riyadh, Saudi Arabia Apsida Life Science Full timeProvide strategic leadership and direction for all medical affairs activities, including clinical development, regulatory affairs, and pharmacovigilance for a Phase 2 ALS programEstablish and nurture collaborative partnerships with key stakeholders, including, regulatory agencies, and clinical research organizations.