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 expected full-year 2021 revenues of $2.48B, a growth of 27% over 2020. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 6,000 people worldwide.
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products. Plan, develop and lead the completion of complex medical writing projects such as CEP/CER. Ensure alignment and compliance with local and regional registration requirements as well as with company policies. Provides input to risk assessment, labeling, 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 and regulatory submissions from clinical perspective.
Essential Duties and Responsibilities:
• Participation in the development of regulatory strategies and prepare regulatory submissions:
- US submissions include IDEs, 510(k)s and Q-Subs
- EU submissions include filing and amending Technical Files/Technical Documentations
- Canada submissions include filing and amending medical device applications
- Other markets as required (collaborate with International team to prepare global strategy)
• Creation, review and approval of labeling
- Approve labeling, including IFUs, packaging, etc.
- Promotional labeling, including advertisements, promotional pieces and professional education materials
• 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
- 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.
• 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 minimal supervision.
• Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling 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 or quality assurance with a minimum of five years in regulatory affairs
• Extensive knowledge of US FDA and EU Medical Device Regulation requirements for the submission of pre- and post-market clinical trial data and reports
• Extensive understanding of related aspects of the medical writing processes and/or systems
• Ideal candidate has extensive experience with clinical study data including:
- CEP and CER development under MEDDEV rev. 4, EU MDR guidance, and applicable MDCGs
- 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
• Ideal candidate has experience and/or a background or aptitude for software engineering, including software development life cycleFunctional 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 labeling, 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.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.
- 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.
ManagementField SalesExperience and Education
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Normally receives little instruction on day-to-day work, general instructions on new assignments.
- Typically requires a Bachelors degree and a minimum of 5-8 years of related experience.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications
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