Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Dexcom Deutschland GmbH

Job

Location:

San Diego, California
Remote work available

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began with a big dream: to forever change how diabetes is managed. Over 25 years, we have pioneered an industry and are expanding our vision beyond diabetes to empower people to take control of health. Our mission is to improve human health through personalized, actionable insights and innovative biosensing‑technology experiences.

Join our world‑class regulatory team and play a key role in bringing Dexcom’s innovative products to markets worldwide. In this dynamic, fast‑paced environment, you will develop and apply advanced regulatory skills while contributing to our record of success, helping empower people across the globe to improve their health with Dexcom Continuous Glucose Monitoring (CGM) products.

• Represent RA on core functional teams for post‑market changes or global software regulatory classification, change management, and regulatory submissions including:
• • US 510(k), pre‑submissions, LTF, MDDS change assessment
  • CE‑marked products under EU MDR: change notifications, technical file update and submissions, MDSS notifications and in‑country registrations
  • ROW: work with regulatory bodies or in‑country representatives for device classification, change assessment, registration and amendments
• Provide direct support to RA team members reviewing and approving marketing claims, labeling and advertising and promotional materials for life‑altering Dexcom products.
• Partner closely with marketing, clinical, medical affairs and other functions to develop and approve impactful compliant advertising and promotional materials.
• Work closely with software development, engineering, architecture, quality and cybersecurity teams to develop and implement streamlined software development processes and documentation to meet regulatory, quality system and compliance requirements.

• Experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO‑14971, ISO‑80001, IEC 62304, IEC 82304) to advise on regulatory strategy.
• Excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions, and experience interacting with regulators.
• Passion for continuous improvement and adapting to change to ensure compliance, especially for global medical device regulations, design controls, change controls and risk management.
• Effective communication and collaboration with cross‑functional partners to ensure alignment and timely review of quality documentation.
• Knowledge and experience in reviewing advertising and promotional materials for medical devices; experience using Veeva Promo Mats is desired.
• Effective verbal and written communication skills.

• A front‑row seat to life‑changing CGM technology and our #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in‑house learning programs and/or qualified tuition reimbursement.
• An exciting, innovative, industry‑leading organization committed to our employees, customers and the communities we serve.

0‑5%

Typically requires a Bachelor’s degree and a minimum of 5–8 years of related experience.

Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site, a hybrid working environment may be available. Ask about our Flex workplace option.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at

$91,400.00 - $