ASP Global · 1 month ago
Director of Research & Development (R&D)
Austell, GA
Full-time
Onsite
Director/ExecutiveASP Global is seeking an experienced and strategic Director of Research & Development (R&D) to lead innovation and product development in the healthcare and medical device industry. This role is responsible for driving the development of breakthrough technologies, ensuring regulatory compliance, and leading cross-functional teams to bring innovative medical solutions to market.
Medical
Responsibilities
Develop and execute the R&D roadmap aligned with business objectives and market needs, focusing on Class I and Class II medical devices
Oversee the ideation, design, and development of next-generation Class I and II medical devices and healthcare technologies
Ensure compliance with regulatory requirements, including FDA 510(k), CE Mark, MDR, and ISO 13485. Collaborate with regulatory and quality teams to support submissions and audits
Work closely with engineering, quality, regulatory, marketing, and contract manufacturing teams to streamline product development from concept to commercialization
Establish and track project timelines, budgets, and deliverables while ensuring alignment with company goals
Identify emerging technologies, foster partnerships with research institutions, and evaluate potential acquisitions or licensing opportunities
Build a high-performing R&D team, fostering a culture of innovation, accountability, and collaboration
Assess technical and regulatory risks, implementing mitigation strategies to ensure project success
Qualification
Required
Strong background in Class I and Class II medical device development
Experience with regulatory frameworks (FDA, MDR, ISO 13485)
R&D leadership experience
Ability to develop and execute the R&D roadmap aligned with business objectives and market needs
Experience overseeing the ideation, design, and development of next-generation Class I and II medical devices and healthcare technologies
Knowledge of regulatory requirements, including FDA 510(k), CE Mark, MDR, and ISO 13485
Experience collaborating with regulatory and quality teams to support submissions and audits
Ability to work closely with engineering, quality, regulatory, marketing, and contract manufacturing teams
Experience in establishing and tracking project timelines, budgets, and deliverables
Ability to identify emerging technologies and foster partnerships with research institutions
Experience in assessing technical and regulatory risks and implementing mitigation strategies
Experience in building and leading a high-performing R&D team
Company
ASP Global
ASP Global is a privately held, Atlanta-based company with additional operations in the Pacific Rim.
Founded in 2003
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Incline Equity Partners
2024-08-06Acquired
2020-02-11Private Equity
Leadership Team
Doug Shaver
Chief Executive Officer
Justin Martin
Chief Product Officer & General Manager, Injury Prevention
Recent News
2023-06-13
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