Top 36 Regulatory affairs Jobs in Carlsbad, Ca

Regulatory Affairs Specialist
Dexcom —San Diego, CA
- $71,600 - $119,300 a year
- Full-time
- Mid-level
- Analysis skills
- Bachelor's degree
- Tuition reimbursement
Sr Regulatory Affairs Specialist
Dexcom —San Diego, CA
- $91,400 - $152,300 a year
- Full-time
- 5 years
- Bachelor's degree
- Machine learning
- Tuition reimbursement
Product Complaint Analyst
inSync Staffing —San Diego, CA
- $36.25 - $45.00 an hour
- Full-time
- Mid-level
- Bachelor's degree
- Fair chance
- Health insurance
- Dental insurance
Quick Apply
2d
Quality Control Analyst
Gallant —San Diego, CA
- From $70,000 a year
- Weekends as needed
- Background check
- Mid-level
- Master's degree
- Health insurance
- Dental insurance
Quick Apply
Clinical Data Specialist II
Alphatec Spine —Carlsbad, CA
- $85,000 - $98,000 a year
- Full-time
- Mid-level
- SQL
- Analysis skills
Quick Apply
Senior Director, Regulatory Affairs-CA
Synchron Inc. —San Diego, CA
- $210,000 - $240,000 a year
- Engineering
- 11+ years
- Office
- Commuter assistance
- Disability insurance
Quick Apply
Consultant, Global Regulatory Affairs
Cullgen —San Diego, CA
- $300 an hour
- Hybrid work
- 11+ years
- Office
- Doctor of Philosophy
Quick Apply
Clinical Scientist II
Alphatec Spine —Carlsbad, CA
- $125,000 - $140,000 a year
- Full-time
- Mid-level
- Doctor of Philosophy
- US work authorization
Quick Apply
Sr Manager Corporate Compliance
Dexcom —San Diego, CA
- $135,100 - $225,100 a year
- Full-time
- 5 years
- Bachelor's degree
- Continuous improvement
- Tuition reimbursement
Senior Packaging and Product Compliance Specialist
Sony Electronics Inc —San Diego, CA
- $84,014 - $112,017 a year
- Full-time
- Microsoft Outlook
- 5 years
- Project management
- Paid parental leave
- Health insurance
Speaker Bureau and KOL Operations Manager
Dexcom —San Diego, CA
- $91,400 - $152,300 a year
- Full-time
- RN License
- Mid-level
- Office
- Tuition reimbursement
- Life insurance
Regulatory Manager- IVD and 510(k)
CorDx —San Diego, CA
- $90,000 - $150,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Senior level
- 401(k)
- Paid time off
Quick Apply
Senior Manager, Pharmacovigilance
ORIC Pharmaceuticals —San Diego, CA
- $150,000 - $180,000 a year
- Full-time
- Nursing
- 5 years
- Writing skills
Quick Apply
Manager OR Senior Manager, R&D Product Transfer - AID
Werfen —San Diego, CA
- $95,000 - $185,000 a year
- Online Application
- Bachelor of Science
- ERP systems
- Bachelor's degree
Senior Project Manager - Associate Director, CMC
CALIDI BIOTHERAPEUTICS INC —San Diego, CA
- $125,000 - $165,000 a year
- Full-time
- Bachelor of Science
- Basic math
- Laboratory experience
- Health insurance
- Dental insurance
Quick Apply
Associate Director, Regulatory and Medical Writer
Ionis Pharmaceuticals, Inc. —Carlsbad, CA
- $142,588 - $201,472 a year
- Hybrid work
- 11+ years
- Bachelor's degree
- Mentoring
Quick Apply
Director of Permitting
SOLV Energy, LLC —San Diego, CA
- $150,080 - $187,600 a year
- Full-time
- 7 years
- Engineering
- Travel
- Paid holidays
- Disability insurance
Quick Apply
Director / Senior Director of Regulatory Operations
Artiva Biotherapeutics —San Diego, CA
- $205,000 - $268,000 a year
- Full-time
- 11+ years
- Bachelor's degree
- Quality control
- Paid holidays
- Disability insurance
Quick Apply
Sr./Clinical Trial Manager
Viking Therapeutics, Inc. —San Diego, CA
- $120,000 - $150,000 a year
- Full-time
- 6 years
- Bachelor's degree
- Team management
Quick Apply
1d
Supervisor, Quality Control Biology
Artiva Biotherapeutics —San Diego, CA
- $110,000 - $135,000 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Management
- Paid holidays
- Disability insurance
Quick Apply

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Regulatory Affairs Specialist

Dexcom -
San Diego, CA

Apply Now

Job Details

Full-time
$71,600 - $119,300 a year

Benefits

Tuition reimbursement

Qualifications

Bachelor's degree

Full 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:

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 support developmental activities for Dexcom software products.
You will develop regulatory strategies and prepare submissions in various countries (US, EU, Canada).
You will collaborate with regional regulatory teams to develop global strategies as required.
You will review and approve product and promotional labeling for software.
You will represent Regulatory Affairs on various cross-functional software teams.
You will review and approve software documentation and evaluate for submission requirements.
You will take on additional projects and responsibilities as needed.

What makes you successful:

You bring knowledge of US and international regulatory requirements including design control, medical device submission requirements, labeling and promotion regulations, and medical device quality systems.
You have Medical Device Software experience and/or knowledge, such as software development lifecycle, IEC 62304, and software classification.
You have strong technical writing, editing, and analytical skills.
You work well independently and with cross-functional teams.
You thrive in a fast-paced environment and adapt quickly to changing priorities.
You are 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 [email protected].

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 [email protected].

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.

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:

$71,600.00 - $119,300.00

#DexcomUS

Apply Now

Refine Your Search

regulatory affairs jobs in carlsbad, ca

Regulatory Affairs Specialist

Sr Regulatory Affairs Specialist

Product Complaint Analyst

Quality Control Analyst

Clinical Data Specialist II

Senior Director, Regulatory Affairs-CA

Consultant, Global Regulatory Affairs

Clinical Scientist II

Sr Manager Corporate Compliance

Senior Packaging and Product Compliance Specialist

Speaker Bureau and KOL Operations Manager

Regulatory Manager- IVD and 510(k)

Senior Manager, Pharmacovigilance

Manager OR Senior Manager, R&D Product Transfer - AID

Senior Project Manager - Associate Director, CMC

Associate Director, Regulatory and Medical Writer

Director of Permitting

Director / Senior Director of Regulatory Operations

Sr./Clinical Trial Manager

Supervisor, Quality Control Biology

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