Our History, Staff Expertise, And Careers
Our History
The CRO Group, Inc. based in Melrose, Massachusetts, a suburb of the metropolitan Boston area, was founded in 1996. Since the company’s inception, the founders have assembled a highly skilled development support, quality and regulatory team as well as established partnerships with other consulting organisations in medical device, consumer health care, and related industries.
Our Mission
We are committed to the satisfaction of our clients. We strive for the highest level of professionalism from our people. We are dedicated to providing value added choices and solutions for our clients where multiple development, quality, and regulatory paths exist. We operate ethically and within all applicable regulatory and standard requirements.
State of the Art
When it comes to tools, this isn’t The CRO Group’s first rodeo. We are familiar and use all the latest tools in supporting and or managing your project – from MS-Project to Smartsheet, to Kanban Development and Project Management Tools such as JIRA, to Inspection and Audit Collaboration support via Slack and Zorro, The CRO Group staff are ready!
Senior Consultants
Our Senior Consultants have over 25 years experience, and specialize in supporting your design and development in IEC 60601-1 electromedical safety testing, IEC 62304 software development life cycle, ISO 14971 Risk Management, IEC 62366 Usability Engineering, ISO 13485, 21 CFR 820 and MDSAP QMS / Regulatory Audit preparations, as well as preparing 510(k)s, de Novo’s, EU Technical Files, and OTC Label Comprehension, Usability, and Safety and Efficacy studies supporting submissions. .
Consultants
Our Consultants are equally strong in medical device design and development, software development, and quality system compliance and regulatory approvals. Most CRO Group Consultants have over 20 years experience preparing 510(k) submissions and international product registrations and have brought dozens of medical device manufacturers through the ISO 13485, CE Mark, and MDSAP certification process..
CRO Group Associates
CRO Group Associates support our Consultants and our Clients for a wide range of projects – from setting up an ISO 13485 and QSR compliant QMS to coordinating a Clinical Study being conducted in China. We have associates with Nursing and advanced Regulatory Affairs degrees who are fluent in Cantonese, English, and Mandarin and hail from the Shenzhen region of China.
Careers at CRO Group
If you’re ready to join our team working with some of the leading as well as startup companies focused on tomorrow’s products in the aesthetic beauty, diagnostic, mobile medical apps, robotics, and wearables, we want to hear from you. The CRO Group offers a dynamic work environment and provides competitive compensation, benefits, and performance-based incentives.Quality/Regulatory Intern
Quality/Regulatory Intern
We are looking for students in a B.S.E.E. at the junior or senior level, or M.S. in Regulatory Affairs with the Knowledge, Skills, and Abilities below:
ESSENTIAL FUNCTIONS
- Support CRO Group consultants working with our clients in upgrading their Quality Management Systems to ISO 13485:2016 compliance as well as towards MDSAP.
- Support CRO Group consultants working with our clients in preparing for IEC 60601-1 test compliance for their electronic medical device products for both FDA 510(k) premarket submissions as well as international registrations.
- Support CRO Group consultants working with our clients in preparing for IEC 62304 compliance for their medical device software, SaMD, and SaaS for both FDA 510(k) premarket submissions as well as international registrations.
KNOWLEDGE, SKILLS AND ABILITIES
- Basic working knowledge of medical device quality systems, electromedical and software life cycle standards
- Able to review regulations/guidances/standards requirements and apply to projects.
- Maintain project info and data including project plans, agendas, minutes, action lists, etc.
- Able to develop basic procedures and document processes
- Proficient with MS Word, Excel, and PowerPoint.
- Able to read and understand technical material.
- Able to communicate across all levels of the organization, work effectively with multiple cultures,
- Works in an organized manner, with attention to detail, and maintains a professional demeanor
- Works in a responsible manner, from filling out timesheets and expense reports accurately on time, to respecting client project deadlines, and everything in between
- Our client’s offices/facilities as well as home office
- Up to 50% travel may be required
Get In Touch With Us Today
If you are interested in working together, please send us an inquiry and we will get back to you as soon as we can!