Are you ready to take your career to the next level by joining a pioneering organization at the intersection of healthcare and AI? Origin Medical Research Lab is on a mission to revolutionize prenatal care through cutting-edge technology, and they are currently looking for a Document Control Specialist (Regulatory Affairs) to be part of their team in Bengaluru, Karnataka. This is an excellent opportunity for skilled professionals in regulatory affairs who want to make a significant impact on maternal health globally.
Company Introduction
Origin Medical Research Lab, a subsidiary of Origin Medical, focuses on integrating healthcare and artificial intelligence (AI) to create groundbreaking solutions aimed at improving maternal healthcare. With headquarters in Cambridge, Massachusetts, Origin Medical has a global mission to democratize access to high-quality prenatal care by leveraging AI technology. By supporting healthcare providers in rural and urban areas alike, they are making strides toward reducing maternal and infant mortality rates.
Responsibilities in the Job
As a Document Control Specialist in the Regulatory Affairs team at Origin Medical Research Lab, you will play a vital role in ensuring compliance with regulatory standards. Your primary responsibilities will include:
- Managing the Master Document List and ensuring up-to-date documentation.
- Supporting the maintenance of Design History Files, Regulatory Technical files, and Device Master Records.
- Assisting in the transition to an electronic Quality Management System (e-QMS) for secure document handling.
- Managing and tracking Document Change Orders, approvals, and training matrices.
- Collaborating on audits with regulatory bodies such as FDA and ISO 13485.
- Organizing regular check-ins and reviews, and identifying areas for continuous improvement.
Qualifications
To qualify for this role, applicants must have:
- A solid understanding of ISO 13485 Quality Management Systems and familiarity with FDA regulations.
- Experience in document control processes and quality assurance in a regulated environment.
- Strong organizational skills and attention to detail.
- Knowledge of data integrity, documentation practices, and computer system validation.
- Experience working with e-QMS software is highly advantageous.
Skills Required
Here’s a breakdown of the essential skills for this position:
- Attention to detail: Precision in handling documents and regulatory processes is crucial.
- Project management: The ability to manage complex processes and collaborate with cross-functional teams.
- Communication skills: Strong verbal and written communication in English is required.
- Problem-solving: Ability to resolve challenges effectively within the regulatory framework.
- Team player: Willingness to collaborate and work in a dynamic, fast-paced environment.
How to Apply
If you are passionate about contributing to innovative healthcare solutions and have a background in regulatory affairs, apply for the Document Control Specialist position at Origin Medical Research Lab. To submit your application,
