Bimini Health Tech · 13 hours ago
Quality and Regulatory Affairs Engineer
DFW Metroplex
Full-time
Onsite
New Grad, Entry LevelBimini Health Tech is a global leader in the women’s health market, focusing on advancing science-driven technologies. They are seeking a Quality and Regulatory Affairs Engineer to ensure compliance with regulatory requirements, maintain quality assurance systems, and prepare regulatory submissions.
Health CareMedical Device
Responsibilities
Ensuring compliance with regulatory requirements
Maintaining quality assurance and management systems
Preparing regulatory submissions
Monitoring and managing product-related regulations
Collaborating with cross-functional teams
Conducting audits to uphold quality standards across processes and products
Qualification
Required
Proficiency in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
Strong knowledge and experience in Quality Management and Quality Assurance processes
Familiarity with global regulatory guidelines, including FDA and ISO standards
Problem-solving skills and the ability to interpret technical and regulatory documentation
Strong organizational, communication, and interpersonal skills
Bachelor's degree in Engineering, Life Sciences, or a related field
Previous experience in the healthcare or medical device industry is highly advantageous
Company
Bimini Health Tech
Bimini Health Tech is a global leader in the breast reconstruction and regenerative product and therapy market.
Founded in 2013
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Bradford Conlan
Founder, CEO & Director
Amy Patton
CFO
Recent News
Company data provided by crunchbase