Director of Research & Development; R&D

Job Details

Job Location
: AUSTELL, GA 30168

Position Type
:
Full Time

Education Level
: 4 Year Degree

Travel Percentage
:
Up to 25%

Job Summary:

We areseekingan experienced and strategic Director of Research & Development (R&D) to lead innovation and product development in the healthcare and medical device industry. This roleis responsible for driving the development of breakthrough technologies, ensuring regulatory compliance, and leading cross-functional teams to bring innovative medical solutions tomarket. 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.

• Strategic Leadership:
  
  Develop and execute the R&D roadmap aligned withbusinessobjectivesand 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, andcontractmanufacturing 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.