Staff Regulatory Affairs Specialist
Dexcom, Inc

Job Info

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About Dexcom:

Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.

Summary:

The Regulatory Affairs Specialist will collaborate with Dexcom's Regulatory and QA teams to ensure that department and corporate goals are met. They will lead or assist in regulatory activities and work with cross-functional teams to meet project milestones.

Essential Duties and Responsibilities:

• Participate in and lead the development of regulatory strategies, regulatory submissions:
  • US submissions including IDEs, Q-Subs, 510(k)s and PMAs
  • EU submissions including MDR documentation submissions, filing change notices and amending Technical Files/Documents
  • Canadian submissions including amendments
  • Support other international regulatory submissions as required
• Creation, review and approval of labeling:
  • Approved 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
  • 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
  • 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.

• • Complaint System
    • Evaluate complaints for potential reporting obligation
  • Internal Audits
    • Participate as an auditor, independently if appropriately trained
• Other duties as assigned.

REQUIRED QUALIFICATIONS

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 5years' experience in a regulated medical device company in regulatory, clinical affairs or quality assurance with a minimum of five years in regulatory affairs, preferably with PMA products.
• Must have strong writing, editing and analytical skills and have experience in developing complex submissions with minimal supervision.
• Good leadership skills and ability to influence change
• Attention to detail is essential
• Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling requirements, quality control, auditing principles, and adverse event reports.
• Prefer experience in pharmaceutical industry as well as medical device experience in US Class II and Class III and EU Class IIb and Class III. Must have knowledge of EU-MDR requirements.
• Must work well independently or within a cross-functional team environment.

EDUCATION

• Bachelor's degree from four-year college or university in engineering or life science; higher degrees can substitute for years of experience.

Functional 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

• Having wide-ranging experience and uses professional concepts and knowledge of company objectives to resolve complex issues in creative and effective ways.
• Possesses knowledge of advanced concepts, techniques, and standards.
• Viewed as expert in the field within the Function.

Scope

• Works on complex issues where analysis of situations or data requires an in-depth evaluation.
• Work is reviewed upon completion for adequacy in meeting objectives.
• Networks with key contacts outside own area of expertise.

Judgement

• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Exercises considerable latitude in determining objectives and approaches to assignment.
• Determines methods and procedures on new assignments and may coordinate activities of other colleagues.

Management

• N/A

Field Sales

• N/A

Experience and Education

• Typically requires a Bachelors degree and a minimum of 8-12 years of related experience.
• At this level a graduate degree may be desirable with 4 years of related experience.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.

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 talentacquisition@dexcom.com.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.

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