DexCom, Inc., a leader in continuous glucose monitoring,
is headquartered in San Diego, California. Our success
is built on innovation, hard work, and on seeing each
other’s differences as an advantage. We are committed to
developing technologies and products that improve the
lives of people with diabetes. DexCom has ambitious
plans to keep learning and growing – and is seeking
people who have the same goals for themselves. DexCom
Inc. is currently seeking a Regulatory Affairs Associate
Collaborate with Regulatory Affairs Management and
assist in regulatory activities and projects to
successfully meet department and corporate goals.
Successful applicants will have substantial IDE and PMA
experience involving a variety of technologies, such as
electronics with programmable software, wireless
communication, biomaterials and nanotechnology.
Complimentary international experience is highly
desirable. Responsibilities (other duties may be
strategies and prepare regulatory submissions.
- Participation in the development of regulatory
- US submissions include IDEs, 510(k)s and PMAs.
- EU submissions include filing and amending
- Other markets as required
- Creation, review and approval of labeling.
- Approved labeling, including IFUs, packaging,
promotional pieces and professional education
- Promotional labeling, including advertisements,
- Medical Device Reports (MDRs).
- EU vigilance Reporting.
- Represent Regulatory Affairs on various
§ Regulatory Affairs is a standing member of the Recall
§ Regulatory Affairs functions as the Recall Coordinator
§ Determines if a correction or removal is necessary and
if notification of any regulatory agency is required.
§ Reviews all news releases or other official company
§ Contribute to the development of the project plan and
§ Represent Regulatory Affairs in the development of
Product Plans, Specifications, Risk Management and other
§ Participate in Design Reviews when appropriate.
§ 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
§ Regulatory Affairs is a standing member of the
- Corrective and Preventative Action (CAPA)
Corrective and Preventive Action Board (CAB).
§ Evaluate complaints for potential reporting
§ Participate as an auditor, independently if
university in engineering major or life science
- Bachelor’s degree from a four-year college or
required. Graduate’s degree or higher can substitute
for years of experience.
medical device company in regulatory affairs,
- Must have 10 years of experience in a regulated
clinical affairs or quality assurance with a minimum
of five years in. Regulatory preferably with PMA
required with experience in developing complex
- Strong writing, editing and analytical skills are
regulatory submissions with minimal supervision.
regulatory requirements including clinical
- Must have knowledge of US and international
regulations, design control, medical device
submissions requirements, labeling and promotion
regulations, quality control, auditing principles,
and adverse event reports.
cross-functional team environment .
- Must work well independently or within a
- Certification as ISO Auditor or ISO Lead Auditor is
DexCom Inc. is a publicly traded company listed in the
NASDAQ stock exchange. We have been FDA approved and
commercially released three generations of continuous
We offer an excellent benefits package including
medical, dental, vision, life insurance and long term
disability, 401(k), flexible spending account, a
discounted employee stock purchase plan, paid time off,
on-site fitness center, and a great work environment.
To apply please go to http://www.dexcom.com/careers.
Division/Department : 22-Regulatory Affairs
% of Travel Required : 0-10%
Offer Relocation : No
# of Openings : 1
DexCom - 2 years ago