Sr Director Regulatory Affairs

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor’s degree with 20+ years of industry experience, 15+ years of successful leadership experience in relevant industry, Strong written and verbal communication skills, Familiarity with the healthcare industry, particularly medical devices or biopharmaceuticals is highly desired..

Key responsabilities:

  • Lead Program Management Office activities within the Regulatory & Government Departments
  • Drive reporting for global regulatory submissions and approvals
  • Manage department budget and resources effectively
  • Lead, coach, and develop regulatory team members.

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Dexcom XLarge https://careers.dexcom.com/careers/index
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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: 

Join our world-class regulatory and government affairs team! Be an important part of our team as we bring Dexcom’s innovative new products to market across the world. Actively contribute within a team of more than 50 regulatory and government professionals and numerous other cross-functional professionals around the world to drive regulatory, governmental, and business deliverables. Be part of this fast-paced global-scope team with an outstanding track record of successes. Be a part of the team that enables more and more people around the world to improve their health as they use our Dexcom Continuous Glucose Monitoring (CGM) products! 

Where you come in: 

  • Lead Program Management Office (PMO) activities and work processes within the Regulatory & Government Departments, ensuring cross-functional alignment across global teams. 
  • Drive Program Management actions and reporting for global regulatory submissions and approvals, including integrating regulatory affairs requirements into project plans, timelines, and deliverables. 
  • Lead Program Management work related to policies, processes, resourcing, tracking, and training, driving continuous improvement initiatives  
  • Lead, coach, develop, support, and grow regulatory and other team members, including managers. 
  • Manage the department budget and resources effectively. Lead the development, implementation, and execution of the department's strategic plan.  

What makes you successful:  

  • You bring strong leadership and management skills that direct, guide, coach, grow, motivate, and ensure success of Regulatory & Government team members performing PMO work. 
  • You have strong written and verbal communication skills. You communicate and collaborate effectively with cross-functional partners to ensure alignment, and timely management of program management activities. 
  • You work to continuously improve and change work processes as work needs change, ensuring compliance and efficiency of current and future work process needs. 
  • You can find and implement solutions to sometimes complex challenges. 
  • You are motivated by working at a fast pace. 
  • You have interest in, or are familiarity with, the healthcare industry. Experience with the medical device or biopharmaceutical industry is highly desired.  
  • You have a demonstrated interest in diabetes (a huge plus!). 
  • You are highly flexible and able to shift priorities as needed. 
  • You are a self-starter with exceptional interpersonal skills.  

What you’ll get: (this section should not be modified) 

  • A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community
  • A full and comprehensive benefits program. 
  • Growth opportunities on a global scale. 
  • Access to career development through in-house learning programs and/or qualified tuition reimbursement. 
  • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.  

Travel Required:  

  • 25 to 50% 

Experience and Education Requirements: 

  • Typically requires a Bachelor’s degree with 20+ years of industry experience 
  • 15+ years of successful leadership experience in relevant industry 

Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

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:

$220,100.00 - $366,800.00

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Program Management
  • Leadership
  • Collaboration
  • Communication
  • Social Skills
  • Adaptability
  • Problem Solving

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