出海雷达

高级经理 - 法规事务 - 拉丁美洲

Sr Manager Regulatory Affairs- LATAM

其他限定地区(需当地身份)
公司Dexcom
薪资$149,000 - $248,300/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间10 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

Dexcom 公司(纳斯达克股票代码:DXCM)是连续血糖监测(CGM)领域的先驱和全球领导者。Dexcom 最初是一家小公司,怀揣着一个宏大的梦想:永远改变糖尿病的管理方式。解锁能够带来更好健康结果的信息和见解。25 年后的今天,我们已经开创了一个行业。而我们才刚刚开始。我们正在将视野从糖尿病扩展到帮助人们掌控自己的健康。这意味着提供个性化的、可操作的见解,以解决重要的健康挑战。继续我们已有的事业:改善人类健康。
我们由成千上万有抱负、充满热情的全球员工驱动,他们愿意像战士一样奋斗,通过倾听、诚信服务、大胆思考和值得信赖来赢得客户的信任。我们已经改变了数百万人的生活,我们准备改变更多人。我们的未来目标是成为领先的消费健康科技公司,同时继续开发针对严重健康状况的解决方案。我们将通过不断重塑独特的生物传感技术体验来实现这一目标。虽然我们已经走过了很长的路,但我们的梦想比以往任何时候都更大。在全球范围内改善健康的机遇就在我们面前。
了解团队:
加入一个充满活力的法规事务团队,该团队在确保合规性和支持 Dexcom 的国际增长方面发挥关键作用。我们热衷于协作、解决问题,并在快速发展的医疗设备行业中产生积极影响。我们的团队崇尚创新、团队合作,途中也有一点乐趣——我们相信,伟大的成果来自优秀的人们共同努力。加入我们,帮助全球各地的人们通过 Dexcom 连续血糖监测(CGM)产品改善他们的健康。
你的职责:

  • 你将制定并推动 Dexcom 在拉丁美洲的法规策略。
  • 你将直接与监管机构互动,影响审查时间并支持积极的监管结果。
  • 你将成为拉丁美洲法规方面的专家和内部联系人,与公司各关键利益相关者保持一致,并确保该地区的法规重点支持公司的商业目标。
  • 你将监督和指导新旧医疗设备的法规活动,以确保符合适用的法规要求和公司政策。
  • 你将负责协调和管理法规事务相关的项目和流程,确保按时完成并符合所有相关法规标准。
查看英文原文

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 a dynamic Regulatory Affairs team that plays a critical role in ensuring compliance and supporting Dexcom’s international growth. We’re passionate about collaboration, problem-solving, and making a positive impact in the fast-paced medical device industry. Our team thrives on innovation, teamwork, and a little fun along the way - we believe great results come from great people working together. Join us and help empower people across the globe to improve their health with Dexcom Continuous Glucose Monitoring (CGM) products.
Where you come in:

  • You will develop and champion Dexcom’s regulatory strategy in Latin America.
  • You will interact directly with regulatory bodies to impact review timelines and support positive regulatory outcomes.
  • You will act as the Latin America regulatory subject matter expert and internal point of contact, maintaining alignment with key stakeholders across the company, and ensuring regulatory priorities in the region support the company’s commercial goals.
  • You will oversee and direct regulatory activities for new and existing medical devices to ensure compliance with applicable regulatory requirements and company policies.
  • You will manage external relationships in Latin America, including consultants, industry organizations, and key opinion leaders. You will represent Dexcom at regional conferences.
  • You will apply your proactive and strategic mindset throughout all stages of project planning and implementation, identifying potential challenges and preparing contingency plans as applicable, in order to reduce overall project risk.
  • You will guide Dexcom’s regulatory staffing strategy for Latin America: attracting talent, developing new team members, and strengthening Dexcom’s regulatory capability in the region.

What makes you successful:

  • You have an in-depth understanding of medical device regulatory requirements in Latin America.
  • You have a proven track record interacting directly with regulatory bodies in the region (ex. ANVISA in Brazil, ANMAT in Argentina, COFEPRIS in Mexico, etc.).
  • You have professional fluency in both English and Portuguese. Professional fluency in Spanish is a plus.
  • You are able to understand and clearly articulate technical, clinical and regulatory details.
  • You have experience managing high-performing teams. You enjoy mentoring and coaching. You believe strongly in developing talent and finding opportunities for your team members to grow and excel.
  • You enjoy developing and implementing new processes as well as identifying efficiencies in current ways of working.
  • You work well independently, as well as within an international and cross-functional team environment.
  • You are proficient in problem solving, proactive learning, organization, and have excellent communication skills.
  • Previous experience with CGMs or other diabetes devices is preferred.

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:
· 15-25%
Experience and Education Requirements:

  • Typically requires a Bachelor’s degree with 13+ years of industry experience
  • 5-8 years of previous people management experience

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 .

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 .

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:

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.
AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary:
$149,000.00 - $248,300.00
#DexcomUS
Originally posted on Himalayas

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