Sr Manager Regulatory Affairs

Sr. Manager, Regulatory Affairs

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.

The Sr. Manager, Regulatory Affairs will work within regulatory affairs and with cross functional teams to lead RA efforts for Dexcom's SaMD products and solutions. The Sr Manager will be responsible for 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 Manager will also lead regulatory strategy for novel digital health tools and features through interactions with regulatory agencies. The Sr Manager 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 will spearhead regulatory strategy and execution for SaMD and SiMD products, features, cloud-based solutions, data connectivity and integration efforts, and other software components within the Dexcom digital health ecosystem. You will also supervise a team of regulatory affairs specialists.
• You are the RA lead on core functional teams for global software regulatory classification, change management, regulatory submissions including :
• US 510(k), pre-submissions, LTF, MDDS change assessment
• CE-marked products under EU MDR : change notifications, technical file update, MDSS notifications and in-country registrations
• ROW : work with regional regulatory teams to help support interactions with regulatory bodies or in-country representatives for device classification assessments, registration and amendments
• You will work with SW development, cybersecurity, architect, quality, product management. Medical / clinical affairs and other cross functional teams to develop and implement streamlined software product development and design control processes to meet regulatory compliance requirements
• You will represent RA in assessment of global cybersecurity, data availability and data privacy initiatives. You are responsible for advising on regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions.

What makes you successful :

You have a strong track record interpreting and implementing SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to advise on regulatory strategy

You have excellent writing skills in regulatory documentation, including classification memos, change assessment / notifications, technical dossier and submissions. You are experienced in interactions 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 excellent verbal and written communication skills, and success in managing a team

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 :

Typically requires a Bachelor's degree with 13+ years of relevant experience in medical device industry in functions such as engineering, regulatory affairs, software quality, digital health product and program management

5-8 years of previous people management experience

A minimum of 5 years of regulatory affairs 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).