Senior Regulatory Affairs Specialist

Found in: beBee jobs SA - 2 weeks ago

Riyadh, Ar Riyāḑ, Saudi Arabia Danaher Full time
The family of Diagnostics companies at Danaher work with conviction that every moment matters and realize that behind every test is a patient, waiting for an answer that could change their life. Our 23,000 team members, across 6 operating companies globally, proudly push the boundaries of what's possible in safeguarding patient health and improving diagnostic confidence. We develop tools and technologies that set the standard for innovation and impact wherever health care happens—from a family physician's office to leading trauma hospitals and laboratories. Our teams collaborate in an inclusive environment as we connect our people, processes, and expertise, focused on the world's biggest health challenges such as cardiac disease, infectious disease, and cancer. At DH Diagnostics, you'll thrive and quickly see the impact of your contribution.In this role, you will have the opportunity to:
  • Identifies 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 document preparation.
  • Maintain files on local, regional, and global regulatory intelligence and other related information.
  • Track the status of applications under regulatory review and provide updates.
  • Helps prepare technical documentation, pre-market authorization applications and change notifications.
  • Generate regulatory reports to communicate local registration activities.
  • Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives.
  • Get along with RSA regulatory leaders and peers to expedite approval of pending registrations.
  • Interact with departments to generate protocols and reports that require in-country testing data for registration purposes.
  • Maintain a "focused vitality" as the need arises by specific events.
  • Recognize problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors.
  • Prepare written reports, PowerPoint presentations, and documents for distribution within work unit and regions.
  • Provide training and coordinate with department personnel from regulatory, quality, and manufacturing sites, Sales, and Marketing.
  • Organizes and maintain RA files such as Responsibilities Matrix, Certificates from Notified Bodies, and other RA related material. Ensures that existing approvals and documentation are maintained.
The essential requirements of the job include:
  • Good organizational skills with attention to detail and accuracy.
  • Ability to work independently in a fast-paced environment with flexibility to manage changing priorities.
  • Able to demonstrate a broad experience of manufacturing processes and equipment.
  • Interprets subjective and intricate aspects of specific regulations and has detailed understanding of multiple sets of associated regulations.
  • Able to confidently deal with ambiguous issues and provide input towards suitable actions.
  • Demonstrated excellence in communicating and presenting complex information to technical and non-technical partners.
  • Proven ability to manage and prioritize multiple projects. Highly motivated, takes initiative, follow through, and complete projects in a professional and timely manner.
  • IVD product experience is highly preferred.
  • Prior knowledge of different databases like SAP, Sales Force, Tarius, Track wise etc. including Agile documentation system is a bonus.
  • Understands Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products.
  • Excellent oral and written communication and presentation skills. Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.
  • Bachelor's degree with 7 years of related work experience.
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.

When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

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.

If you've ever wondered what's within you, there's no better time to find out.

  • Regulatory Affairs Manager, Hospital Patient Monitoring META

    Found in: beBee jobs SA - 1 week ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Philips Full time

    Job 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...

  • Logistics Quality Specialist

    Found in: beBee jobs SA - 3 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Danaher Full time

    Wondering what's within Beckman Coulter Diagnostics? Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds,...

  • Senior Quality Compliance Specialist

    Found in: beBee jobs SA - 3 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Serco Plc Full time

    Senior Quality Compliance SpecialistMake a difference every day We are a multinational organisation with a global team of 50,000 colleagues. In the Middle East we operate in the Transport, Defence & Advisory sectors, delivering services in Asset Management, Customer Experience, Fire & Rescue and Air Navigation Services. We are innovators, committed to...

  • Audit Specialist

    Found in: beBee jobs SA - 2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Saudi Telecom Company Full time

    Job SummaryIs to shape the regulatory environment to optimize STC's position and to be aware of international economic changes and technological innovations, in order to create recommendations for STC's future positioning, products and services. This job family also constitutes jobs, which ensure that STC carries out an effective lobbying operation to...

  • Senior FM Planning Specialist

    Found in: beBee jobs SA - 3 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Serco Plc Full time

    The Senior FM Planning Specialist Make a difference every day We are a multinational organization with a global team of 50,000 colleagues. In the Middle East we operate in the Transport, Defence & Advisory sectors, delivering services in Asset Management, Customer Experience, Fire & Rescue and Air Navigation Services. We are innovators, committed to...

  • Senior Facility Handover Specialist

    Found in: beBee jobs SA - 3 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Serco Plc Full time

    Senior Facility Hanover Specialist Make a difference every day We are a multinational organization with a global team of 50,000 colleagues. In the Middle East we operate in the Transport, Defence & Advisory sectors, delivering services in Asset Management, Customer Experience, Fire & Rescue and Air Navigation Services. We are innovators, committed to...

  • Senior CRM Specialist

    Found in: beBee jobs SA - 3 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Serco Plc Full time

    Senior CRM Specialist - Saudi NationalMake a difference every day We are a multinational organisation with a global team of 50,000 colleagues. In the Middle East we operate in the Transport, Defence & Advisory sectors, delivering services in Asset Management, Customer Experience, Fire & Rescue and Air Navigation Services. We are innovators, committed to...

  • Senior Legal Researcher

    Found in: beBee jobs SA - 1 week ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Saudi Telecom Company Full time

    Job SummaryJobs at this level are responsible for providing paralegal services to lawyers including investigating facts, preparing legal documents and researching legal precedent to support legal proceedings, legal studies or other investigations.Core ResponsibilitiesPrepares legal documents, including briefs, contracts, agreements, pleadings and appeals and...

  • Risk Specialist

    Found in: beBee jobs SA - 2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Saudi Telecom Company Full time

    Job SummaryJobs at this level are responsible for conducting internal and external regulatory audit tasks, analysis and developing reports with an aim to identify risks areas of concerns and opportunities of improvement. Also, they are responsible for reviewing the delivery of reports and analysis conducted by senior analysts/analysts and recommending...

  • Sr Biopharmaceutical Representative

    Found in: beBee jobs SA - 6 days ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Amgen Full time

    As a Senior Biopharmaceutical Representative, the role involves developing strategic plans to sell biopharmaceutical products to healthcare professionals and other potential customers. The representative builds strong relationships with key industry stakeholders and stays updated with industry trends and regulatory requirements.

  • Regulatory Financial Reporting Specialist Professional

    Found in: beBee jobs SA - 3 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Mobily Full time

    Job SummaryLiaise with all Finance sections and other functional departments to ensure timely organized closing and extraction of related reports. Prepare consolidated annual Zakat and withholding tax declarations for Mobily and observe adopting adequate presentation to ensure adherence to Saudi tax and Zakat laws. Identify and extract taxable payments to...

  • Tariff Approvals

    Found in: beBee jobs SA - 2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Mobily Full time

    Job Summary Contributes to the development of Mobily's regulatory departmental policies and procedures Liaise with regulatory body to determine tariff model and understand the regulatory principles as embodied in the formation document to ensure presenting best practice and full compliance Develop detailed model to analyse various scenarios to ensure that...

  • Senior Legal Counsel

    Found in: beBee jobs SA - 2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Jameson Legal. Full time

    A leading organisation is seeking to hire an experienced Lawyer, who can add value to their legal team and advise as to the company's regulatory and compliance matters. This is an excellent opportunity to join a company that envision revolutionising the economy of the Kingdom, and be a part of a project that is innovative and unique.The role involves...

  • Shipping Cordinator

    Found in: beBee jobs SA - 2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Danaher Full time

    To process and administer the movement of customer orders from order entry to delivery in compliance with global and local regulations. To foster an end to ending thinking approach by ensuring a reliable supply to our customers through order management operations & excellent customer service.ESSENTIAL JOB RESPONSIBILITIES:Prepare relevant import...

  • Job Title: Distribution Specialist

    Found in: beBee jobs SA - 2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Danaher Full time

    The Distribution specialist for Radiometer is responsible for the order flow from end-to-end is distributed in compliance with global and local regulations through efficiency processes and collaboration. This position is based in Riyadh and will be on-site. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient...

  • Senior Planning Manager

    Found in: beBee jobs SA - 1 week ago

    Riyadh, Ar Riyāḑ, Saudi Arabia KBR Full time

    Title:Senior Planning ManagerThe Senior Planning Manager plays a crucial role in the successful execution of a portfolio of Programmes, Districts, Mega Projects and Projects. They oversee and manage all aspects of Planning & Scheduling ensuring effective large volume data management, baselining, quality assured progress outputs, forecasts, trends and...

  • ServiceNow Senior Technical Consultant

    Found in: beBee jobs SA - 6 days ago

    Riyadh, Ar Riyāḑ, Saudi Arabia DXC Technology Full time

    Job Description:Responsibilities:Work with clients to understand business processes and requirementsDesign, develop, and implement customized solutions using the ServiceNow platformConfigure and customize ServiceNow modules and integrate with third-party applicationsProvide technical leadership and mentorship to junior team membersCollaborate with...

  • HRS Specialist

    Found in: beBee jobs SA - 2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Saudi Telecom Company Full time

    Job SummaryJobs at this level are responsible for managing the day-to-day operations of Human Resources activities including supervising collation of requisite HR data, managing routine tasks in the design of frameworks, conducting training need analysis, organizing internal training programs and reviewing relevant reports. Also, they are responsible for...

  • Technical Project Specialist

    Found in: beBee jobs SA - 2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Saudi Telecom Company Full time

    Job summaryJobs at this level are responsible for effectively supervising STC's low budget and/or low risk technical projects with respect to time and project schedules. Also, they may be expected to coordinate and perform administrative tasks for high budget and/or high risk projects.Key ResponsibilitiesManages the day to day team operations within a...

  • Security Implementation Specialist Professional

    Found in: beBee jobs SA - 1 week ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Mobily Full time

    Job SummaryParticipate in the review and study of high level and low level security designs and evaluate technical requirements in order to plan the integration of new security services/ enhancements . Carry out feasibility studies and evaluations for the security solution rollout plans and projects in coordination with other teams. Contribute in defining...