![Philips](https://assets.phenompeople.com/CareerConnectResources/PHILGLOBAL/images/job_logo_config-1596629400797.png)
Regulatory Affairs Manager, Hospital Patient Monitoring META
4 weeks ago
Job 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 regulatory processes for registrations and labeling deviations across the HPM Businesses.
- Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions.
- Ensure compliance to relevant regulations and other Regulatory Requirements and as required, guidelines and policies to all HPM products and operations are consistent with those regulations.
- Lead the Planning, generation, and coordination of regulatory submissions for HPM product/solution licensing.
- Proactive stakeholder management in BU.
- Define and implement appropriate regulatory certifications for sites. Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business and / or Market.
- Formulates and recommends (changes to) policies and establishes procedures that affect immediate organization(s).
- Being part and execute the regulatory compliance guidance and regulatory streamline operational excellence between HPM groups /sites and Markets to ensure time to market on global initiatives especially related to new projects involving Regulatory for key decision makers.
- Develop and maintain, execute and track elicit regulatory requirements as per each country required for regulatory compliance and local regulations and tracking progress of project trackers for the markets impacted against planning, submissions and approvals deadlines
You're the right fit if:
Education: Bachelor's degree.
•Experience: At least preferably 6 years of Regulatory Affairs experience in medical industries or pharma sectors.
•Excellent command of English and Arabic is required.
•Be familiar with ISO 13485, ISO 9001 ,MDD 93/42/EEC or EU-MDR.
•Excellent organization and coordination skills.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
-
Regulatory Affairs
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Radiometer Full timeIn 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...
-
Regional Regulatory Affairs Specialist
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Dexcom Full timeAbout DexcomFounded in 1999, Dexcom, Inc (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...
-
Regulatory Affairs Specialist Middle East
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Abbott Laboratories Full timeAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.You will...
-
Regulatory Affairs Manager
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Al Safa Pharmaceutical Store Full timeRegulatory Affairs Manager:- Job SummaryTasks and Responsibilities- contributing to the organization's strategic plan and annual plans, in areas such as quality and risk management, regarding registration matters;- writing and periodically updating drug regulatory affairs (DRA)-related local SOPs;- reviewing draft registration files and submitting new and...
-
Regulatory Affairs Executive
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Aramed Full timeREGULATORY AFFAIRS EXPERIENCED Coordinate with project lead and stakeholders to assess and define projects scope, requirements and timelines for proper planning and execution. Act as a point of contact and communicate project status with countries. Coordinate with Logistics/ Supply Chain/ Labeling teams and manufacturing site to obtain valid artworks and...
-
Regulatory Affairs Supervisor
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia MS Pharma Injectable Full timeYou must first log in before applying to jobs. The Regulatory Affairs Supervisor is responsible for preparing registration dossiers for new products, line extensions, and new indications. They will also be responsible for maintaining the license of existing registered products by managing all regulatory activities throughout the product lifecycle.Main...
-
Regulatory affairs specialist
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Alewan Full timeWe are looking to hire Regulatory Affairs Specialist to be a part of our Regulatory Affairs team.Requirements:2-3 years' experience in pharmaceuticals registration is mandatoryFood Supplements and medical devices are added benefit.Aware of SFDA Requirements and regulation.Excellent organizational and presentation skills.Proactive and Punctual.Location:...
-
Regulatory Affairs Coordinator
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Boston Scientific Corporation Full timeRegulatory Affairs Coordinator - Tamheer Program:Remote Eligible: HybridOnsite Location(s): Riyadh, SAWork Location : Riyadh, Saudi ArabiaKey Responsibilities: Give support on regulatoryrelated issues associated with compliance and achieving the business plan. Will be introduced to product registration planning and prioritization for his/her respective...
-
Regulatory Affairs Manager
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Abbott Laboratories Full timeJob TitleRegulatory Affairs ManagerAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true...
-
Regulatory Affairs ExecutiveSpecialist
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Precision Hire Solution Full timeAbout Zahrawi GroupZahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE KSA Qatar Bahrain & Oman markets. The company supplies and distributes highquality products and services to Hospitals Clinics Laboratories & Analytical Industries. job Brief The incumbent is responsible for all Product Classification/Manufacturing...
-
Regulatory Affairs Lead
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Johnson & Johnson Full timeAbout Johnson & Johnson:For our Local Operating Company in Saudi Arabia, we are currently recruiting for a Regulatory Affairs Expert to be based in our Riyadh office. In this role you will be leading our Regulatory activities across the region, as well as support a team based across the KSA and Gulf cluster. This role is an excellent opportunity for...
-
Senior Regulatory Affairs Manager
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Biogen Full timeJob Description Purpose**: The incumbent will work in close collaboration with GCC Regulatory and commercial organizations, International Growth markets (IGM), Development, Chemistry, Manufacturing and Control (CMC) Regional contacts as well as relevant global, regional and local stakeholders.He/she will lead local regulatory activities in KSA to ensure...
-
Regulatory Affairs Specialist
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Genesis Executive Full timeThis role is based in Riyadh, Saudi ArabiaOverviewResponsible for regulatory affairs activities to assist in regulatorysubmission, annual reports, registrations and listings. Assurecompliance with applicable medical device regulations per jurisdiction,guidance and standards. Assist in creation and maintenance ofregulatory files.Job ResponsibilitiesWrite,...
-
Patient Safety
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia King Abdullah bin Abdulaziz University Hospital Full time**Key Accountabilities & Responsibilities Participates in the monitoring, education, and coordination of Risk Management and Patient Safety Program related activities for clinical and nonclinical services. Assists with the Implementation of the Risk Management, Patient Safety Program, Plans and Initiatives including:Conducting Patient Safety Culture Surveys...
-
Regulatory Affairs Executive/specialist
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Zahrawi Medical Full timeAbout Zahrawi Group:Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.job Brief: The incumbent is responsible for all Product...
-
Manager, Patient Safety
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia King Faisal Specialist Hospital and Research Centre Full timeDevelops the Patient Safety Plan in line with the hospital's mission, vision, provision of service and strategic objectives, Coordinates the plan with the Patient Safety team and counterparts in KFSH&RC branches, and leads its execution. Assume responsibility of leading, organizing and executing all patient safety related activities.Essential...
-
Supervisor, Central Patient Transport
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia King Faisal Specialist Hospital and Research Centre Full timeSupervises the operations of Central Patient Transport (CPT) and provides patient services as needed in an effort to improve patient satisfaction. Assures that standards of scheduling, patient care, and efficiency are maintained in accordance with Hospital policies & procedures.Essential Responsibilities and Duties: Supervises daily work and activities of...
-
Regulatory Affairs Specialist
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Haleon Full timeHello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human...
-
Regulatory Affairs Manager
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Mindfield Resources Full timeJob Description:Job description:Your role :As an integral part of the team, your role would entail overseeing day-to-day operational activities, and collaborating with both internal and external stakeholders to ensure timely submission and approvals of regulatory activities while proactively communicating the progress of such activities. Your deep...
-
Regulatory Affairs Manager
2 weeks ago
Riyadh, Ar Riyāḑ, Saudi Arabia Mindfield Resources Full timeJob Description:Your role: As an integral part of the team, your role would entail overseeing day-to-day operational activities, and collaborating with both internal and external stakeholders to ensure timely submission and approvals of regulatory activities while proactively communicating the progress of such activities. Your deep understanding of the...