Origin Medical Research Lab Hiring for Document Control Specialist (Regulatory Affairs)
| Position | Document Control Specialist (Regulatory Affairs) |
|---|---|
| Company | Origin Medical Research Lab |
| Location | Bangalore |
| Experience | 1 to 12 Years |
| Salary | Not Disclosed (Variety of Roles) |
| Start Date | September 28, 2024 |
| Education Requirement | Knowledge of ISO 13485 and FDA Regulations |
| Skills Needed | Communication, Time Management, Flexibility, Problem Solving |
| Key Responsibilities | Managing documents, e-QMS transition, regulatory audits, change orders |
Step into Innovation with Origin Medical as a Document Control Specialist
Are you ready to take your career in regulatory affairs to the next level while contributing to the future of healthcare? At Origin Medical Research Lab, you’ll have the chance to play a key role in transforming prenatal care through cutting-edge artificial intelligence (AI) solutions. If you are passionate about regulatory affairs and document control, this is a fantastic opportunity to impact maternal health globally. Origin Medical is seeking a Document Control Specialist (Regulatory Affairs) for their Bengaluru, Karnataka office to help manage the regulatory documents critical to ensuring that innovative healthcare solutions reach the people who need them most.
Who is Origin Medical Research Lab?
Origin Medical Research Lab is a subsidiary of Origin Medical, an organization dedicated to integrating healthcare and AI technology to revolutionize maternal healthcare. Headquartered in Cambridge, Massachusetts, Origin Medical is on a global mission to make high-quality prenatal care accessible to everyone, no matter their location. Through their AI-driven solutions, they are changing the face of maternal and infant health, particularly in rural and underserved areas. By working with Origin Medical, you’ll be part of an organization that is not only advancing technology but also making a tangible difference in healthcare outcomes.
What You’ll Do as a Document Control Specialist
As a Document Control Specialist in the Regulatory Affairs team at Origin Medical Research Lab, you’ll ensure that all documentation processes meet the highest regulatory standards. From managing crucial documents to assisting in regulatory audits, your work will be critical in ensuring compliance with industry standards such as FDA regulations and ISO 13485 Quality Management Systems.
Key responsibilities include:
- Managing the Master Document List: You’ll maintain and ensure all documents are up-to-date and comply with regulatory standards.
- Supporting Regulatory Files: From Design History Files to Regulatory Technical Files and Device Master Records, you will oversee and manage essential records that are crucial to compliance.
- Transitioning to e-QMS: You’ll assist in the transition to an electronic Quality Management System (e-QMS), ensuring secure, streamlined document handling and tracking.
- Document Change Orders: Managing and tracking Document Change Orders and ensuring approvals and training are documented properly will be a significant part of your role.
- Regulatory Audits: You will collaborate with regulatory bodies such as the FDA and ensure that all required documentation is audit-ready, adhering to standards like ISO 13485.
- Continuous Improvement: Regular reviews and process improvement initiatives will be your contribution toward making the document control process even more efficient.
What Do You Need to Succeed?
To be successful in this role, you must have a strong foundation in ISO 13485 Quality Management Systems and be familiar with FDA regulations. Experience in document control and quality assurance within a regulated environment is essential, and working knowledge of e-QMS software will give you an edge.
The key skills required include:
- Attention to Detail: Precision in handling documentation and ensuring all files meet regulatory standards is a must.
- Project Management: You’ll need to manage complex processes and timelines, so strong project management skills are essential.
- Communication: Strong verbal and written communication skills in English are required, as you’ll be working with cross-functional teams.
- Problem Solving: You’ll be tasked with resolving challenges efficiently while adhering to regulatory guidelines.
- Team Player: Collaboration is key in this dynamic, fast-paced environment. You must be comfortable working closely with others toward shared goals.
Why Join Origin Medical?
By joining Origin Medical, you are not only advancing your career but also contributing to groundbreaking solutions in maternal healthcare. This position gives you the opportunity to be part of a team that is making real-world impacts by improving access to quality prenatal care for women globally. If you’re a regulatory affairs professional eager to bring your skills to a mission-driven organization, Origin Medical Research Lab is the perfect place to grow and make a difference.
Ready to make an impact in healthcare? Apply now to become a Document Control Specialist at Origin Medical Research Lab and help revolutionize maternal health with AI technology!