Sr. Operational Compliance Specialist at Dexcom, Inc in Sacramento, California

Job Description:

The Company



Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.


We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.



Meet the team:



Supports regulated activities and projects to successfully meet department and corporate goals. Key contributor in support and collaboration for the following:

• Global (primarily Asia Pacific region) distribution and manufacturing licensing


• Quality Management System Regulation and Standards


• Additional responsibilities as assigned.

Works closely with Quality, Regulatory Affairs, Commercial, Legal, Supply Chain, and Operations to ensure compliance with numerous global registration and licensing requirements.



Where you'll come in:

• Work is primarily achieved independently or through project teams, utilizing technical or subject-matter expertise to achieve results.


• Requires specific expertise in professional / functional area(s)


• Emphasizes in-depth technical / subject-matter knowledge, project management and influence skills.


• Is expected to communicate laterally and engage others across the organization and have some level of influence on decisions.

What makes you successful:

• Managing cross-functional projects in support of facility registration submissions to regulatory bodies and other business critical initiatives from planning through closure.


• Coordinates cross-functional teams through meetings, monitoring progress and ensuring completion on time.


• Planning, execution, and delivery of documentation in preparation for submission of global site registration applications or renewals.


• Conducts impact assessments related to functional area, in support of critical business processes and operational changes.


• Identify opportunities for improvements and efficiencies in cross-functional communication and coordination.


• This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.

Required Qualifications:

• Strong project management skills, with ability to coordinate cross-functional teams.


• Must be able to comfortably communicate assertively with project stakeholders regarding timelines and dependencies


• Must be able to build and sustain partnerships within the organization and with applicable regulatory bodies and Dexcom's representatives to such bodies.


• Solution-driven, risk/impact-based mentality, with a "get it done, the right way" approach.


• Ability to interpret and coordinate responses to requests from regulatory bodies or Dexcom's representatives to such bodies.


• Excellent communication skills with the ability to convey quality, and business information clearly and effectively verbally and through informal and formal documents, reports, and presentations.


• Experience in a regulated environment, preferably within medical device, pharma, aerospace, or similar industry.

Preferred Qualifications:

• Familiarity with global medical device manufacturing and distribution licensing laws, rules, and statutes.


• Experience working with regulatory bodies or in-country representatives to such bodies to gain approval or implement changes to facility-related registrations (e.g., Japan FMR, Japan QMS, Korea KGMP Cert, Australia CaC, UAE Manufacturing license, India import license, etc.)

Experience and Education Requirements:

• Typically requires a Bachelor's degree and a minimum of 5 - 8 years of related experience

Travel Required:

• Up to 10%

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.


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.


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.


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


Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true


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.


Salary:
$82,900.00 - $138,100.00 Apply Now