Staff Regulatory Affairs Specialist

Meet the team:

Join our world-class Regulatory Affairs team to play an important role in bringing Dexcom’s innovative new products to market across the world. We are a team of more than 40 professionals who drive regulatory and business deliverables. Be part of this fast-paced global-scope team with an outstanding track record of successes. Our team members hold diverse backgrounds, including biological and physical sciences, engineering, political science, biostatistics, pharmacology, and law, among others. Our academic credentials range from Bachelor's degrees to Master's degrees, Ph.D.s, JDs, and more. Leveraging our varied expertise and skills, we facilitate the alignment and management of the company's initiatives to ensure successful delivery of our home-use products to end-users.

We maintain close collaboration with departments such as Quality Assurance, Clinical, Medical, Government Affairs, and Global Business Solutions (GBS), all under the leadership of the same Executive Vice President. Through our strategic work, we also partner with cross-functional teams in R&D (HW and SW), Ops, PMO, Marketing, etc. We regularly engage in both in-person and virtual team-building activities to foster camaraderie and strengthen our working relationships.

If you join our team, you will be supporting the growth and expansion of Dexcom’s Continuous Glucose Monitoring (CGM) Systems and software products.

Where you come in:

• You will collaborate with management in the development of regulatory strategies for new and sustaining products including performing impact assessments and preparation of regulatory submissions:
  • US: 510(k)s, IDEs, Q-Subs, Letters to File
  • Canada: Health Canada amendments
  • EU: MDR technical documentation filings and amendments
  • Other markets as required (collaborate with International team to prepare global strategy)
• You will serve as a key opinion leader of Regulatory Affairs through mentoring, conducting training on regulatory topics, and participating in agency meetings
• You will help create, review, and approve product labeling, including IFUs, packaging, promotional labeling, etc.
• You will represent Regulatory Affairs on various cross-functional teams:
  • Design Control – You will contribute to the development of the project plan and other deliverables.  You will represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management, and other required documents.  You will participate in Design Reviews as appropriate.
  • Change Control – You will represent Regulatory Affairs as a standing member of the Change Control Board (CCB).  You will create and revise procedures as needed.  You will review and approve change orders and evaluate for submission requirements.
• You will work closely with R&D, Marketing, Operations, and Product Management to innovate and achieve our mission of empowering people to take control of their health
• You will set an example for the team in maintaining regulatory compliance through staying current on applicable procedures, regulations, guidance and other applicable requirements
• You will perform other duties as assigned.

What makes you successful:

• You have strong knowledge of US and international regulatory requirements including design control, medical device submission requirements, labeling and promotion regulations, and medical device quality systems.
• You have excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions. You have experience interacting with regulators.
• You work well independently and with cross-functional teams and thrive in a dynamic setting.
• You are proficient in problem solving, proactive learning, organization, and have excellent communication skills.
• You enjoy working on 510(k) submissions, Health Canada submissions, or EU Medical Device Regulation.
• You have Medical Device Software experience and/or knowledge, such as software development lifecycle, IEC 62304, and software classification.

What you’ll get:

• A front row seat to life changing CGM technology. Learn about our brave #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 and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required:

• 5-15%