Post-Market Product Surveillance Specialist 2 at Dexcom in San Diego, California

Job Description:

About Dexcom:

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

Summary:

The Customer Advocacy Specialist demonstrates a high-level of proficiency in post-market product surveillance activities as they relate to complaint handling and global health authority reporting. This position is responsible for supporting the leadership team in the maintenance and monitoring of complaint files, complaint processing systems, investigations and closures, national competent authority communication, corrective action and preventive actions (CAPA), product investigations and maintenance of other related quality system records as required. Provide consultation and guidance to key stake holders and cross-functional partners in the area of global complaint handling and health authority reporting.

Functional Description: Professional Individual Contributor

Responsible for the in-depth review, analysis and maintenance of the processes, activities and tools used for complaint handling associated to post-market product performance. Develop and maintain regulatory compliance mitigation searches and techniques (quality monitoring, etc.) to ensure record quality and minimize/prevent potential instances for late health authority reporting. Serves as a cross-functional liaison and subject matter expert in the area of post-market surveillance as it relates to complaint handling and product performance; collaborating with Customer/Technical Support, Field Failure Analysis, Quality Assurance, Quality Compliance, Regulatory, R&D, Human Factors, and Marketing & Commercialization Teams. Involvement in product development to ensure post-market product performance trends are accounted for in new product design as well as current product enhancements. Participate and provide input on Corrective Action, Preventative Action (CAPA) and Health Hazard Assessment (HHA) core teams. Systematically review and analyze complaint classification codes to ensure the appropriate characterization of possible product malfunction/safety issues are available for accurate post-market product performance tracking and trending. Responsible for timely response to requests for additional information from National Competent Authorities on a global scale, requiring partnership across multiple applicable business functions and executive leadership. Develop, deploy & maintain training curriculum and tools to support global business process alignment and standardization across multiple sites located in multiple countries. Partner cross-functionally to support the deployment of methodologies and tools, such as robotic process automation efforts and complaint system updates to promote operational excellence throughout the global organization.

Essential Duties and Responsibilities:

• Systematically review and analyze complaint records at all complexity levels for possible product malfunction/safety issues to ensure accurate classification and post-market product performance trending.


• Assists in leading and may provide guidance on complaint investigations and mentors less senior team members.


• Draft, organize, and ensure timeliness of submission of global health authority reports to applicable national competent authority.


• Develop and maintain regulatory compliance mitigation searches and techniques (quality monitoring, etc.) to ensure record quality and minimize/prevent potential instances for late health authority reporting.


• Serves as a cross-functional liaison in the area of post-market surveillance as it relates to complaint handling and product performance, collaborating with Customer/Technical Support, Field Failure Analysis, Quality Assurance, Quality Compliance, Regulatory, R&D, Human Factors, and Marketing & Commercialization Teams.


• Participate and provide input on Corrective Action, Preventative Action (CAPA) and Health Hazard Assessment (HHA) core teams.


• Draft, organize and ensure timely response to requests for additional information from National Competent Authorities on a global scale, requiring partnership across multiple applicable business functions and executive leadership.


• Support the development, deployment & maintenance of training curriculum and tools to support global business processes across multiple sites located in multiple countries.


• Partner cross-functionally to support the deployment of methodologies and tools, such as robotic process automation efforts and complaint system updates to promote operational excellence and scalability throughout the global Customer Advocacy organization.


• Establish new and/or revise procedures/work instructions to ensure compliance with domestic and international regulations within the framework of established policies and procedures.


• Support internal, external, and third-party audits.


• Manage small projects and contribute to large projects.


• Assume and perform 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.

• Professional experience in biotech, medical device or pharmaceutical industry.


• Demonstrate high-level proficiency post-market product surveillance activities as they relate to complaint handling and global health authority reporting in compliance with all domestic and international regulations (i.e., MDD, EU MDR, CFR, ISO13485 and other applicable regulations)


• Ability to work independently with minimal supervision and as a team player within a department as well as with other departments.


• Highly organized and can work independently as well as within a team.


• Strong ability to collaborate and drive results.


• Builds productive and collaborative internal/external working relationships.


• Ability to define problems, collect data, establish facts, and draw valid conclusions.


• Effective verbal, listening, and written communication skills.


• Intermediate computer software skills in all basic applications i.e., Microsoft Office, Outlook, Zoom, Etc.


• Flexible and able to manage and prioritize multiple projects in a fast-paced environment.


• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Preferred Qualifications:

• Experience communicating with global regulatory authorities.


• Experience drafting or updating procedures


• Experience training, mentoring, and developing team members.


• Knowledge of and experience in field of diabetes and CGM technology is highly desirable.

Experience and Education Requirements:

• Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience.

• Minimum 2 years related experience in Quality Assurance and/or biotechnology; or equivalent combination of education and experience.

Functional/Business Knowledge:

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.


• General application of concepts and principles.


• Demonstrates project management skills and successful track record of completion.


• Contributes to the development of new concepts, techniques, and standards.

Scope:

• Receives general oversight and guidance on approaches to compete project related tasks.


• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.


• Develops solutions to a variety of problems.


• Builds productive internal/external working relationships.

Judgement:

• Exercises judgment within defined procedures and practices to determine appropriate action.


• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Travel Required:

• 0 - 24%

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 Talent Acquisition at talentacquisition@dexcom.com.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.