Job Location AUSTELL, GA 30168 Position Type Full Time Education Level 4 Year Degree Travel Percentage Up to 25%
We are 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. The ideal candidate will have a strong background in Class I and Class II medical device development, regulatory frameworks (FDA, MDR, ISO 13485), and R&D leadership.
Key Responsibilities:
Strategic Leadership: Develop and execute the R&D roadmap aligned with business objectives and market needs, focusing on Class I and Class II medical devices.
Innovation & Product Development: Oversee the ideation, design, and development of next-generation Class I and II medical devices and healthcare technologies.
Regulatory & Quality Compliance: 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.
Cross-Functional Collaboration: Work closely with engineering, quality, regulatory, marketing, and contract manufacturing teams to streamline product development from concept to commercialization.
Project Management: Establish and track project timelines, budgets, and deliverables while ensuring alignment with company goals.
Technology Scouting & Partnerships: Identify emerging technologies, foster partnerships with research institutions, and evaluate potential acquisitions or licensing opportunities.
Team Leadership & Development: Build a high-performing R&D team, fostering a culture of innovation, accountability, and collaboration.
Risk Management: Assess technical and regulatory risks, implementing mitigation strategies to ensure project success.
Qualifications & Requirements:
· Education: Minimum Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Life Sciences, or a related field.
·
Experience: Minimum 10+ years of experience in R&D leadership within the medical device or healthcare industry, specifically in Class I and II devices.
· Technical Expertise: Strong knowledge of Class I and II medical device design, biomaterials, manufacturing processes, and relevant regulatory pathways.
· Regulatory Knowledge: Experience with FDA 510(k), MDR, ISO 13485, and GMP requirements for Class I and II medical devices.
· Project & Budget Management: Proven track record in leading multiple projects within time and budget constraints.
· Leadership Skills: Demonstrated ability to lead cross-functional teams and drive innovative solutions.
· Communication & Problem-Solving: Strong analytical, decision-making, and communication skills.
Preferred
Qualifications:
· Experience in med-surgical devices including: operating room, intensive care unit.
· Prior experience in leading R&D in a startup or high-growth environment.
· Knowledge of clinical trials, human factors engineering, and reimbursement strategies for Class I and II devices.
ASP Global is a privately held, Atlanta-based company with additional operations in the Pacific Rim. ASP Global is a leading global sourcing agent/wholesaler of medical supplies with a proven track record. Our expert management team has decades of experience in the healthcare and sourcing industries. Our knowledgeable staff can provide direction on a wide range of medical supplies, including disposables, rehab supplies, equipment and surgical products – including foam, plastics, metals, wood, textiles, and electronics. Our long-standing relationships with 120+ factories enable us to deliver high quality products at factory pricing directly to our clients. We place the highest value on providing customer service excellence with the utmost integrity.
We have been recognized annually by Inc. Magazine since 2008 as one of the fastest growing companies in the United States.
By providing direct relationships with the manufacturers of medical products, ASP Global cuts out the middlemen and enables healthcare providers access to a global supply market. ASP Global eliminates millions in unnecessary cost for marketing, promotions and selling expense that sit between OEM’s and providers without eliminating product quality. We cut out the cost of the middlemen’s branded products and pass the saving on directly to our customers.
Our mission is to provide our customers with top quality medical supplies at the most competitive pricing – plus, the type of delightful customer service you may never thought possible. We look forward to serving you. To get started, simply click or call (404) 696-6999 to contact ASP Global today.
