Dexcom
Regulatory Affairs Specialist
Dexcom, San Diego, California, United States, 92189
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:
Regulatory Affairs is a team of more than 40 professionals located either at San Diego HQ or remotely around the globe. Our backgrounds range from biological and physical sciences to engineering, political science to biostatistics, pharmacology to law just to name a few. Our degrees include Bachelor's, Master's, Ph.D.'s, JD's and more. With our various backgrounds and talents we help to navigate and align the ideas and output of most facets of the company to successfully get our home-use products to our end users. We're closely connected with QA, Clinical, IT, and Global Business Solutions (GBS) under the same Executive Vice President. At our quarterly onsite gatherings, some of our pastimes include story sharing, cooking and baking, social events and other team-building activities.
If you join our team you will be supporting the growth and expansion of Dexcom's Continuous Glucose Monitoring (CGM) Systems.
Where you come in:You will assist in the support and sustaining activities for Dexcom's CGM products.You will participate in the development of regulatory strategies and help prepare regulatory submissions:
US submissions include 510(k)s, IDEs, and Q-SubsHealth Canada amendmentsEU submissions include technical documentation filings and amendmentsOther markets as required (collaborate with International team to prepare global strategy)
You will help create, review, and approve product labeling, including IFUs, packaging, promotional labeling, etc.You will represent Regulatory Affairs on various cross-functional teams:
Design Control - You will contribute to the development of the project plan and other deliverables. You will represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management, and other required documents. You will participate in Design Reviews as appropriate.Document Control - You will represent Regulatory Affairs as a standing member of the Change Control Board (CCB). You will create and revise procedures as needed. You will review and approve change orders and evaluate for submission requirements.
You will perform other duties as assigned.What makes you successful:
You bring knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submission requirements, labeling and promotion regulations, quality control, and medical device quality systems.You have strong technical writing, editing, and analytical skills.You must work well independently and within a cross-functional team environmentYou must be proficient in problem solving, proactive learning, organization, and have excellent communication skills.Having previous experience with 510(k) submissions, Health Canada submissions, or EU Medical Device Regulation is preferred.What you'll get:
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:
5-15%Experience and Education Requirements:
Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience.
Flex Workplace:
Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
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:$68,200.00 - $113,600.00
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:
Regulatory Affairs is a team of more than 40 professionals located either at San Diego HQ or remotely around the globe. Our backgrounds range from biological and physical sciences to engineering, political science to biostatistics, pharmacology to law just to name a few. Our degrees include Bachelor's, Master's, Ph.D.'s, JD's and more. With our various backgrounds and talents we help to navigate and align the ideas and output of most facets of the company to successfully get our home-use products to our end users. We're closely connected with QA, Clinical, IT, and Global Business Solutions (GBS) under the same Executive Vice President. At our quarterly onsite gatherings, some of our pastimes include story sharing, cooking and baking, social events and other team-building activities.
If you join our team you will be supporting the growth and expansion of Dexcom's Continuous Glucose Monitoring (CGM) Systems.
Where you come in:You will assist in the support and sustaining activities for Dexcom's CGM products.You will participate in the development of regulatory strategies and help prepare regulatory submissions:
US submissions include 510(k)s, IDEs, and Q-SubsHealth Canada amendmentsEU submissions include technical documentation filings and amendmentsOther markets as required (collaborate with International team to prepare global strategy)
You will help create, review, and approve product labeling, including IFUs, packaging, promotional labeling, etc.You will represent Regulatory Affairs on various cross-functional teams:
Design Control - You will contribute to the development of the project plan and other deliverables. You will represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management, and other required documents. You will participate in Design Reviews as appropriate.Document Control - You will represent Regulatory Affairs as a standing member of the Change Control Board (CCB). You will create and revise procedures as needed. You will review and approve change orders and evaluate for submission requirements.
You will perform other duties as assigned.What makes you successful:
You bring knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submission requirements, labeling and promotion regulations, quality control, and medical device quality systems.You have strong technical writing, editing, and analytical skills.You must work well independently and within a cross-functional team environmentYou must be proficient in problem solving, proactive learning, organization, and have excellent communication skills.Having previous experience with 510(k) submissions, Health Canada submissions, or EU Medical Device Regulation is preferred.What you'll get:
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:
5-15%Experience and Education Requirements:
Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience.
Flex Workplace:
Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
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:$68,200.00 - $113,600.00