elemed · 4 days ago
Director of Regulatory Affairs
SD Metro Area
Full-time
Onsite
Director/Executive
10+ years expElemed is a world leader at the forefront of healthcare innovation. The Director of Regulatory Affairs will support US and Global regulatory strategy and submissions for their flagship product while leading a team to ensure regulatory compliance.
Medical Device
Hiring Manager
Samuel Crossman
Responsibilities
Lead and develop direct report associates to ensure regulatory compliance
Problem solve and escalate regulatory and compliance issues to senior management as vital
Provide effective leadership and team development, effective communication, and quick responses to customers
Drive continuous improvement in internal processes and customer satisfaction
Identify, develop, and mentor impactful regulatory talent
Author and organize regulatory submission content (510(k), Technical Files, etc.)
Lead regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
Support the monitoring, interpreting, and implementing of current and new regulatory requirements and international standards for U.S., EU., and RoW
Assure that QMS requirements are followed and executed consistently from RA perspective
Oversee efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
Support regulatory impact assessments for change controls and other RA/QA items from a review and approval level
Assists in preparing, auditing, editing, and publishing registration documentation, as needed
Qualification
Required
Bachelor's degree in RA, QA, engineering, or other science-related discipline
Minimum of 10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field
Minimum of 7 years of personnel management (direct report) experience, including performance evaluations/improvement, and career development
Software experience, including SaMD/SiMD
Regulatory and Quality Information Management systems such as SAP, RIM, or related systems
Digital literacy MS Word, Excel, PowerPoint, Teams
Project Management experience
Knowledge of global Regulatory Affairs requirements, regulations and Standards
Experience authoring regulatory submissions (US and Global)
Strong prioritizing, interpersonal, communication, and analytical skills and the ability to multi-task disparate projects
Read, analyze, and interpret regulatory literature and documents and effectively communicate information to peers and management
Preferred
Advanced degree (e.g. MS, PhD)
RAPS RAC certification
Cybersecurity experience
Worked with complex medical devices
Company
elemed
We're on a mission to accelerate the availability of healthcare products through the power of people. Because healthcare touches us all.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase