Synergen Technology Labs is a leading medical device design company specialized in Internet of Things medical devices for the United States market. We are committed to improving patient care and safety through the design and production of cutting-edge medical devices. Our company values innovation, quality, and regulatory compliance as key pillars of our success.
We are seeking a highly motivated and detail-oriented Quality and Regulatory Intern to join our team. As an intern, you will work closely with our Quality and Regulatory Affairs team to support various projects related to compliance with industry standards and regulations governing medical devices. This internship offers a unique opportunity to gain hands-on experience in quality and regulatory affairs within the medical device industry. You will work alongside experienced professionals, contributing to the development of innovative medical technologies while ensuring compliance with applicable regulations.
- Assist in the implementation and maintenance of the Quality Management System (QMS) in accordance with applicable regulations, including ISO 13485 and FDA Quality System Regulation (QSR).
- Support the preparation, review, and revision of quality and regulatory documents, such as Standard Operating Procedures (SOPs), work instructions, and quality records.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements during the design, development, and manufacturing stages of medical devices.
- Contribute to the creation and maintenance of regulatory submissions, including 510(k) pre-market notifications and technical documentation for CE marking.
- Conduct research on relevant regulations and industry best practices to support the team in staying updated on changes that may impact the company's products or processes.
- Assist with the coordination and execution of validation activities, including process validation, software validation, and design verification and validation.
- Participate in training programs to develop a comprehensive understanding of quality and regulatory requirements within the medical device industry.
- Currently enrolled in or recently completed a Bachelor's degree in a relevant field such as Biomedical Engineering, an applicable engineering discipline, Science, Statistics, or a related area of study.
- Familiarity with medical device regulations and standards such as ISO 13485, FDA guidelines, MDR, etc., is advantageous.
- Strong attention to detail and excellent organizational skills to effectively manage multiple tasks and prioritize responsibilities.
- Proficient communication abilities in English, encompassing both written and verbal skills, coupled with the capability to collaborate and excel within a diverse, multidisciplinary team.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant software applications.
- A proactive and self-motivated attitude with a desire to learn and contribute to a fast-paced and challenging work environment.
If you are passionate about improving patient care through quality and regulatory excellence, we encourage you to apply. To be considered, kindly send your CV along with details highlighting your pertinent qualifications and skills to firstname.lastname@example.org.