elemed · 4 days ago
Associate Director Regulatory Affairs
SD Metro Area
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expElemed is seeking an Associate Director of Regulatory Affairs to lead regulatory submission activities for various initiatives. This role involves collaborating with cross-functional teams on submission strategies and interfacing with regulators to ensure timely completion of submission milestones.
Medical Device
Hiring Manager
Samuel Crossman
Responsibilities
Lead regulatory submission activities for various initiatives
Work closely with cross-functional teams on submission strategy and documentation development for new product submissions
Coordinate interactions between internal stakeholders and external service providers to ensure timely completion of submission milestones
Assist in the maintenance of departmental systems used to track projects and ongoing operational activities
Directly interface with regulators as needed
Qualification
Required
Bachelor's degree science STEM engineering
Minimum of 10 years of relevant experience in the medical device industry within Quality and/or R&D, including at least 5 years in Regulatory Affairs
Must have hands-on experience with complex medical device systems and software, specifically Class II or higher devices
Experience working with external service providers, consultants, and regulators
Minimum of 1–2 years of proven experience in people management, including team leadership and performance oversight
Demonstrated interpersonal skills necessary to optimally collaborate across departments and geographies required
Preferred
Advanced degree, master's degree or higher preferred with a focus in a scientific discipline preferred
Familiarity with Infusion Pump Systems preferred
Regulatory Affairs Certification (RAC) preferred
Project Management Certification preferred
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