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.
Collaborate with Regulatory Affairs Management and assist in regulatory activities and projects to successfully meet department and corporate goals.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Coordinate, manage, and participate in the development of regulatory strategies and prepare regulatory submissions.
- US submissions include IDEs, 510(k)s and PMAs
- EU submissions include filing and updating Technical Files
- Other markets as required
- Respond to questions from regulatory agencies
- Participate in meetings with regulatory agencies (e.g., pre-sub meetings)
- Create, review and approve labeling
- Approved labeling, including IFUs, packaging, etc.
- Promotional labeling, including advertisements, promotional pieces and professional education materials.
- Represent Regulatory Affairs on various cross-functional teams:
- Design Control
- Contribute to the development of the project plan and other deliverables.
- Represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management and other required documents.
- Participate in Design Reviews when appropriate
- Document Control
- Regulatory Affairs is a standing member of the Change Control Board (CCB)
- Create and revise procedures as needed.
- Review and approve change orders and evaluate for submission requirements.
- Internal Audits
- Respond to third party and internal auditor’s questions
- Conduct personnel training on FDA and ISO requirements.
- Review and approve site and corporate procedures as appropriate.
- Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements. Monitor external publication sources for issues applicable to Company.
- Other duties as assigned.
This job has no direct reports. The Senior Specialist may lead regulatory affairs project teams as needed. Responsibilities include interviewing and training employees; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
A Bachelors degree required, emphasis in engineering or life science preferred. Higher degrees can substitute for years of experience.
Preferred to have five years’ experience in a regulated medical device company in regulatory, clinical affairs or quality assurance with a minimum of three years in regulatory affairs, preferably with PMA products.
Must have strong writing, editing and analytical skills and have experience in developing complex submissions with minimal supervision. Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports.
Must work well independently and within a cross-functional team environment.