Position - Quality and Regulatory Intern
Location: Nawala, Nugegoda
Job Type: Internship
Duration: 6 months
Synergen Technology Labs is a leading medical device design company specialized in Internet of Things medical devices for the United States market. We are seeking a highly motivated and detail-oriented Quality and Regulatory Intern to join our team. This internship offers a unique opportunity to gain hands-on experience in quality and regulatory affairs within the medical device industry.
Responsibilities
• 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.
Qualifications
• Candidate should either be fresh graduates or undergraduates with pending results from fields such as Biomedical/ Engineering/Science/ Statistics or a related area of study from a recognized university.
• Strong interpersonal skills and Proficient communication abilities in English, encompassing both written and verbal skills, coupled with the capability to collaborate and excel within a diverse, multidisciplinary team.
• 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.
• 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 a fresh graduate or undergraduate who will be graduating soon and passionate about improving patient care through quality and regulatory excellence, we encourage you to apply.
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