Sr Manager Regulatory Affairs

The Company reputed company Corporation (reputed company DXCM) is a pioneer and global leader in reputed company glucose monitoring (CGM). reputed company began as a small company with a big reputed company: To forever change how diabetes is managed. To unlock information and insights that drive reputed company reputed company. Here we are 25 years reputed company, having pioneered an industry. And we're just getting started. We are broadening our reputed company reputed company diabetes to reputed company people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue reputed company've started: Improving reputed company 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 reputed company, thinking big, and being dependable. We've already changed millions of lives and we're reputed company to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to reputed company 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 reputed company. The opportunity to improve health on a global scale stands before us. Meet the team: The Sr. manager, Regulatory Affairs will work reputed company regulatory affairs and with cross functional teams to reputed company RA efforts for reputed company’s SaMD products and solutions. The Sr Manger will be responsible for product classifications, change assessments, registration and approval for software products, including mobile applications, AI/ML enabled data products, reputed company-based solutions and cybersecurity initiatives. The Sr Manager will also reputed company 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, reputed company-based solutions, data connectivity and integration efforts, and other software components reputed company the reputed company digital health ecosystem. You will also supervise a team of regulatory affairs specialists.
• You are the RA reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company in managing a team

What you’ll get:

• A reputed company row seat to life changing CGM technology. Learn about our reputed company #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• reputed company to career development through in-house learning programs and/or reputed company 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

reputed company 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 reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km). Please note: The information contained herein is not intended to be an reputed company-inclusive list of the duties and responsibilities of the job, nor are they intended to be an reputed company-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 reputed company individuals with disabilities to reputed company essential functions. An Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. reputed company’s AAP may be viewed upon request by contacting reputed company at talentacquisition@reputed company.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 reputed company reputed company at talentacquisition@reputed company.com. Meritain, an reputed company Company, creates and publishes the Machine-Readable Files on behalf of reputed company. 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 reputed company Staffing and reputed company Agencies: Our Careers Site is only for individuals seeking a job at reputed company. Only authorized staffing and reputed company agencies may use this site or to submit profiles, applications or resumes on specific requisitions. reputed company does not accept unsolicited resumes or applications from agencies. Please do not reputed company resumes to the reputed company, reputed company employees or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes/applications. Salary: $141,800.00 - $236,400.00 Apply tot his job Apply To this Job