Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.
Director, Regulatory Affairs has overall responsibility for leading all aspects of global regulatory affairs. This includes directing all regulatory affairs activities to ensure global product registration and compliance objectives are met, interfacing with global regulatory agencies and building a high performing team. Director, Regulatory Affairs collaborates and provides guidance to R&D, marketing, quality and other functional groups on regulatory matters and provides leadership for global regulatory approval processes.
Essential Duties and Responsibilities:
Lead the development of global regulatory strategies for CGM product development and sustaining projects. Working through cross-functional teams, explore regulatory pathways, assess and communicate key activities and associated risks.
Ensure preparation of U.S. FDA 510(k), IDE and PMA and global regulatory submissions for new and current products as required. Ensure that all submissions are accurate, completed in a timely manner and meet Dexcom standards.
Assess the skills and competencies of department regulatory professionals. Recruit, develop and retain regulatory professionals who demonstrate exceptional performance and leadership potential. Develop strong bench strength for department positions.
Provide leadership and support for external audits by FDA, notified bodies and other regulatory authorities.
Review product labeling and marketing materials to ensure compliance with regulatory requirements.
Provide guidance, interpretation, and opinions on changing worldwide regulations, while maintaining active involvement in medical device and regulatory affairs organizations to ensure up-to-date knowledge of current and future industry trends.
Develop working relationships with key personnel/representatives of global regulatory authorities.
Develop and communicate a compelling regulatory strategy and mission. Provide subject matter leadership, training and vision to the regulatory team.
Manage the annual operations budget for the regulatory affairs department.
This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.
More than 10 years' experience in a medical device (preferred) or pharmaceutical company
A minimum of 8-10 years of Regulatory Affairs supervisory experience
Strong knowledge of FDA, EU, Health Canada and other applicable international regulatory requirements including clinical trial requirements, quality system requirements, submission requirements, labeling and promotion requirements
Working knowledge of software development life cycle, agile processes, including mobile technologies required
Knowledge of diagnostic medical devices
Candidate must have good written and analytic skills
Must work well independently or within a cross-functional team environment
Bachelor's degree in Life Science or Engineering required
Advanced degree in Life Science or Engineering preferred
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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 Talent Acquisition at email@example.com.
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