Regulatory Affairs Associate III
DexCom - San Diego, CA
Job Description:
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
III.
Summary
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
assigned)
  • Participation in the development of regulatory
strategies and prepare regulatory submissions.
  • US submissions include IDEs, 510(k)s and PMAs.
  • EU submissions include filing and amending
Technical Files.
  • Other markets as required
  • Creation, review and approval of labeling.
  • Approved labeling, including IFUs, packaging,
etc.
  • Promotional labeling, including advertisements,
promotional pieces and professional education
materials.
  • Reporting
  • Medical Device Reports (MDRs).
  • EU vigilance Reporting.
  • Represent Regulatory Affairs on various
cross-functional teams:
  • Corrections and Removals
§ Regulatory Affairs is a standing member of the Recall
Team.
§ 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
statements.
  • 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.
  • Corrective and Preventative Action (CAPA)
§ Regulatory Affairs is a standing member of the
Corrective and Preventive Action Board (CAB).
  • Complaint System
§ Evaluate complaints for potential reporting
obligation.
  • Internal Audits
§ Participate as an auditor, independently if
appropriately trained.
Requirements
  • Bachelor’s degree from a four-year college or
university in engineering major or life science
required. Graduate’s degree or higher can substitute
for years of experience.
  • Must have 10 years of experience in a regulated
medical device company in regulatory affairs,
clinical affairs or quality assurance with a minimum
of five years in. Regulatory preferably with PMA
products.
  • Strong writing, editing and analytical skills are
required with experience in developing complex
regulatory submissions with minimal supervision.
  • Must have 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 .
  • Certification as ISO Auditor or ISO Lead Auditor is
desirable.
About DexCom
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
glucose monitors.
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 - save job - block
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