Regional Regulatory Affairs Specialist
6 months ago
About Dexcom
Founded 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 healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.
**Summary**:
**Functional Description**:
- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.
- Compiles all materials required in submissions, license renewal and annual registrations.
- Recommends 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.
**Essential Duties and Responsibilities**:
- Leverage software and/or data analytics expertise to develop streamlined regulatory pathways for complex and innovative data-driven products.
- Represent Regulatory Affairs on various cross-functional teams:
- Design Control
- Contribute to the development of the project plan and other deliverables.
- Represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management and other required documents in MENA region
- Participate in Design Reviews when appropriate
- Document Control
- Regulatory Affairs is a standing member of the Change Control Board (CCB)
- Create and revise procedures as needed.
- Review and approve change orders and evaluate for submission requirements.
- Internal Audits
- Participate as an auditor, independently if appropriately trained
- Other duties as assigned.
**Required Qualifications**:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
- Must have strong writing, editing and analytical skills and have experience in developing complex submissions with mínimal supervision.
- Knowledge of MENA region US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labelling and promotion regulations, quality control, auditing principles, and adverse event reports.
- Must work well independently or within a cross-functional team environment.
**Preferred Qualifications**:
- Experience in a regulated medical device company in regulatory, clinical affairs, engineering or quality assurance
- Extensive knowledge of US FDA and EU Medical Device Regulation requirements for the submission of pre
- and post-market clinical trial data and reports in the MENA region
- CER development under MEDDEV rev. 4 and EU MDR guidance
- Familiarity with clinical study designs and biostatistics
- Previous work in or with Clinical or Medical Affairs with a background in science or an aptitude for scientific disciplines, such as clinical data analysis or biomedical engineering
**Functional/Business Knowledge**:
- A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
- Demonstrates further technical development and a track record of project success.
- Demonstrates an ability to coordinate multiple projects simultaneously.
- Considered a specialist in the field within the function.
**Scope**:
- Assists in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Networks with senior internal and external colleagues in own area of expertise.
**Judgement**:
- Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
- Normally receives little instruction on day ‐ to ‐ day work, general instr
-
Regulatory Affairs Specialist
6 months ago
Riyadh, Saudi Arabia Alcon Full timeAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...
-
Regulatory Affairs Specialist
6 months ago
Riyadh, Saudi Arabia Boston Scientific Corporation Full time**Regulatory Affairs Specialist, KSA**: - Work mode: Hybrid- Onsite Location(s): Riyadh, SA**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing...
-
Regulatory Affairs Lead
7 months ago
Riyadh, Saudi Arabia Johnson & Johnson Full time**About 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...
-
Regulatory Affairs Specialist
6 months ago
Riyadh, 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...
-
Senior Regulatory Affairs Specialist
6 months ago
Riyadh, Saudi Arabia Cepheid Full time**In this role, the associate**: - Identify information sources and resources for local regulations. - Serve as RA lead on global Market Expansion registrations for simple to medium complicated projects for initial product approvals and renewals, for assays, instruments or software, in global regions outside US and EU to ensure OTD product launches. - Be...
-
Regulatory Affairs
6 months ago
Riyadh, 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...
-
Regulatory Affairs Manager
6 months ago
Riyadh, Saudi Arabia Al Safa Pharmaceutical Store Full time**Regulatory Affairs Manager**: - **Job Summary** Tasks 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...
-
Associate, Regulatory Affairs
6 months ago
Riyadh, Saudi Arabia Hikma Pharmaceuticals PLC Full timeTo coordinate regulatory activities throughout the regulatory life cycle by carrying out project specific tasks related to writing and collecting submission documents from cross functional departments to ensure an efficient preparation of submissions that comply with latest regulations and within the defined timelines. **Description**: Follows all relevant...
-
Regulatory Affairs Supervisor
6 months 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...
-
Regulatory Affairs Officer
7 months ago
Riyadh, Saudi Arabia Kinetic Full time**Kinetic** has partnered with a multinational **Pharmaceutical** company who are hiring a **Regulatory Affairs Officer** to be based in **Riyadh**.** *** **_Please note that due to Saudization, only Saudi Nationals can be considered for this role._** *** **The main responsibilities will include but not limited to**: - Track and follow up with the...
-
Government & Regulatory Affairs Professional
6 months ago
Riyadh, Saudi Arabia IBM Full timeIntroduction At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most...
-
Senior Regulatory Affairs Manager
8 months ago
Riyadh, Saudi Arabia Biogen Full time**Job 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...
-
Reg Affairs
6 months ago
Riyadh, Saudi Arabia Boston Scientific Corporation Full time**Reg Affairs - P4**: - Work mode: Hybrid- Onsite Location(s): Riyadh, SA**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees,...
-
Regulatory Affairs Executive- Riyadh
7 months ago
Riyadh, Saudi Arabia Danone Full timeAbout the job Danone MENA is looking for a talented **Regulatory affairs executive** to be based in **Riyadh, Saudi Arabia**, like you! In the context of Specialized Nutrition MENA, you will be responsible for managing regulatory submissions within the pharmaceutical industry. This involves preparing and submitting documents to regulatory Manager, ensuring...
-
Deputy Regulatory Affairs Manager
6 months ago
Riyadh, Saudi Arabia Kinetic Full time**Kinetic** has partnered with a leading **Pharmaceutical** company who are hiring a **Deputy Regulatory Affairs Manager** to be based in **Riyadh**.** **Key aspects of the role include**: - Develop and implement regulatory strategies to ensure timely and successful product registrations and approvals. - Prepare, and execute regulatory operational plans...
-
Regulatory Affairs Manager, Hospital Patient
6 months ago
Riyadh, Saudi Arabia Philips Full time**Job Title**: Regulatory Affairs Manager, Hospital Patient Monitoring META **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...
-
Regulatory Affairs Specialist
6 months ago
Riyadh, Saudi Arabia Al Safi-Danone Co.Ltd. Full time**Role Purpose**: To validate artworks and product advertisements and ensure they follow the SFDA and GSO standards and to keep quality certificates updated as required. **Key Accountabilities**: - Lead the process of validation artworks (Marketing, R&D &Agency) - Reviewing and validating product artwork from Quality, Regulatory and R&D perspective -...
-
Sr Associate Regulatory Affairs
6 months ago
Riyadh, Saudi Arabia Amgen Full time**Regional Specific Activities** - Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements. - Contribute to and execute the filing plan for their country where applicable - Review source text for country labeling - Review promotion and non-promotion materials - Disseminate relevant information to team(s)...
-
Regulatory Affairs Executive
6 months 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...
-
Medical Affairs Director
6 months ago
Riyadh, Saudi Arabia Johnson & Johnson Full time**Johnson & Johnson Janssen **is recruiting for **Medical Affairs Director **to be located in **Riyadh, KSA.** Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of...