Sr. Regulatory Affairs Specialist at Dexcom

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Requirements, Medical Device Submission, Technical Writing, Analytical Skills, Problem Solving, Communication Skills, Software Development Lifecycle, Quality Control, Medical Device Quality Systems

Industry

Medical Equipment Manufacturing

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. If you join our team you will be supporting the growth and expansion of Continuous Glucose Monitoring (CGM) System. Where you come in: You will collaborate with in-country regulatory representatives, develop regulatory strategies, and prepare regulatory submissions for India and other APAC countries. You will help create, review, and approve product labeling, including IFUs, packaging, etc. for the APAC region. You will represent Regulatory Affairs on various cross-functional teams and provide strategic input and technical guidance on regulatory requirements in the APAC region. You will provide regulatory guidance to the software development team in our Bengaluru office. You will review advertising and promotional materials to ensure they comply with local requirements. You will assess the regulatory impact of proposed design and manufacturing changes and carry out the necessary regulatory actions. You will review new and changing regulations in the APAC countries and assess impact to existing registrations and internal procedures. Provide regulatory support for internal and external audits. You will perform other duties as assigned. What makes you successful: You bring knowledge of India and international regulatory requirements including medical device submission requirements, labeling and promotion regulations, quality control, and medical device quality systems. You have Medical Device Software knowledge, such as software development lifecycle, IEC 62304, and software classification. You have strong technical writing, editing, and analytical skills. You must work well independently and within a cross-functional team environment You must be proficient in problem solving, proactive learning, organization, and have excellent communication skills. Having previous experience with regulatory submissions in India 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: 15-25% Experience and Education Requirements: Typically requires a Bachelor's degree and a minimum of 5 - 8 years of related experience 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.

Responsibilities

You will collaborate with in-country regulatory representatives and develop regulatory strategies for the APAC region. Additionally, you will review product labeling and provide regulatory guidance to cross-functional teams.