Senior Regulatory Affairs Specialist

Meet the team:

Join our world-class regulatory team and play a key role in bringing Dexcom’s innovative products to markets worldwide. As part of our dynamic, fast-paced team, you’ll have the opportunity to develop and apply advanced regulatory skills while contributing to our record of success. Help empower people across the globe to improve their health with Dexcom Continuous Glucose Monitoring (CGM) products. Collaborate across the organization to lead regulatory activities for our industry-leading Dexcom products.

Where you come in:

• You will represent regulatory affairs on various cross-functional teams supporting product changes, design control activities, and compliance issues;
• You will participate in planning, preparation, submission, and maintenance of various marketing applications for the United States (US) and Canada (Q-Subs, 510(k)s, IDEs, license applications and license amendments), and technical documentation files for the European Union (EU);
• You will review and approve change orders, and assess associated regulatory impacts, to support design or manufacturing changes;
• You will author Letters to File (LTFs) and Notified Body Change Notifications;
• You will review and approve product labeling and marketing materials, as needed, to ensure compliance with regulatory requirements;
• You will provide regulatory support as needed for various post-market activities, including quality audits and regulator inquiries;
• You will perform other duties as assigned.

What makes you successful:

• You demonstrate proficiency in US and EU medical device requirements, including but not limited to design control and quality system regulations, regulatory submission requirements, and labeling requirements; knowledge of Health Canada medical device regulatory requirements is a plus;
• You have direct experience with supporting regulatory submissions, such as 510(K)s, new license applications, license amendment applications, or technical documentation files;
• You have working knowledge of international medical device standards, such as ISO 13485 and ISO 14971; familiarity with IEC 60601-1 or ISO 10993-1 a plus;
• You have strong technical writing, editing, and analytical skills;
• You must work well independently and within a cross-functional environment;
• You must be proficient in problem solving, proactive learning, organization, and have excellent communication skills.

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:

• 0-5%

Experience and Education Requirements:

• Typically requires a Bachelor’s degree and a minimum of 5 – 8 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

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:

$91,400.00 - $152,300.00