Sr Regulatory Affairs Specialist

Dexcom; California (MO); Hybrid; USD 80,000 - 100,000; Full time

Job summary

A leading company in continuous glucose monitoring is seeking a Sr. Regulatory Affairs Specialist. This role involves working with cross-functional teams to ensure compliance for software products, including mobile applications and AI-enabled solutions. The ideal candidate will have extensive experience in regulatory affairs and a passion for digital health products.

Benefits

Comprehensive benefits program

Growth opportunities

Career development programs

Qualifications

• Minimum 5 years in medical device industry.
• At least 2 years of regulatory affairs experience.

Responsibilities

• Lead RA efforts for SaMD products.
• Support product classifications and regulatory submissions.
• Advise on global cybersecurity and data privacy initiatives.

Skills

Regulatory Affairs

Communication

Digital Health

Education

Bachelor's degree

Job description

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 :

The Sr. Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to lead RA efforts for Dexcom’s SaMD products. The Sr. Regulatory Affairs Specialist will be responsible for supporting product classifications, change assessments, registration and approval for software products, including mobile applications, AI / ML enabled data products, cloud-based solutions and cybersecurity initiatives. The Sr. Regulatory Affairs Specialist will work with software, algorithm development R&D, quality assurance teams to help streamline internal processes in compliance to applicable FDA guidance documents and international standards.

Where you come in :

• You are the RA representative on core functional teams for global software regulatory classification, change management, and regulatory submissions including :
• US (k), pre-submissions, LTF, MDDS change assessment
• CE-marked products under EU MDR : change notifications, technical file update and submissions, MDSS notifications and in-country registrations
• ROW : work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments
• You will work closely with SW development, engineering, architect, quality and cybersecurity teams to develop and implement streamlined software development processes and documentation to meet regulatory, quality system and compliance requirements
• You are responsible for advising on and representing RA in the assessment of global cybersecurity and data privacy initiatives, regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions.

What makes you successful :

• Your experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-, ISO-, IEC IEC ) to effectively advise on regulatory strategy
• You have excellent writing skills in regulatory documentation, including classification memos, change assessment / notifications, technical dossier and submissions. You have experience interacting with regulators.
• You are passionate about digital health products in a regulated environment, strong understanding or mobile / web development, AI / ML technologies, analytics and working knowledge of agile software development methodologies.
• You have effective verbal and written communication skills

What you’ll get :

• A front row seat to life changing CGM technology. .
• 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 :

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 :

The Sr. Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to lead RA efforts for Dexcom’s SaMD products. The Sr. Regulatory Affairs Specialist will be responsible for supporting product classifications, change assessments, registration and approval for software products, including mobile applications, AI / ML enabled data products, cloud-based solutions and cybersecurity initiatives. The Sr. Regulatory Affairs Specialist will work with software, algorithm development R&D, quality assurance teams to help streamline internal processes in compliance to applicable FDA guidance documents and international standards.

Where you come in :

• You are the RA representative on core functional teams for global software regulatory classification, change management, and regulatory submissions including :
• US (k), pre-submissions, LTF, MDDS change assessment
• CE-marked products under EU MDR : change notifications, technical file update and submissions, MDSS notifications and in-country registrations
• ROW : work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments
• You will work closely with SW development, engineering, architect, quality and cybersecurity teams to develop and implement streamlined software development processes and documentation to meet regulatory, quality system and compliance requirements
• You are responsible for advising on and representing RA in the assessment of global cybersecurity and data privacy initiatives, regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions.

What makes you successful :

Your experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-, ISO-, IEC IEC ) to effectively advise on regulatory strategy

You have excellent writing skills in regulatory documentation, including classification memos, change assessment / notifications, technical dossier and submissions. You have experience interacting with regulators.

You are passionate about digital health products in a regulated environment, strong understanding or mobile / web development, AI / ML technologies, analytics and working knowledge of agile software development methodologies.

You have effective verbal and written communication skills

What you’ll get :

A front row seat to life changing CGM technology. .

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 :

Bachelor’s degree with a minimum of 5 years of relevant experience in medical device industry in functions such as software engineering, regulatory affairs, software quality, digital health product management

A minimum of 2 years of regulatory affairs experience required

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.

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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 : 87,.00 - $,.00

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