Regional Regulatory Affairs Specialist

2 months ago

Riyadh, Saudi Arabia Dexcom Full time

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

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