- Title: QMS Specialist
- Code: RCI-28927543
- Location: Saint Louis Missouri (MO) 63122
- Posted Date: 11/27/2019
- Duration: 1 Years
- Name:Prince Dash
- Email: email@example.com
- Phone: 908-704-8843 ✖ 234
Job Description: -
Quality and Regulatory expert that is responsible for identifying and fixing potential risks related to MDR requirements.
"Most Critical Job Requirements (""Must Haves"")
- Medical device professional who has quality experiences international Quality System Regulation (QSR) standards.
- System Regulation, ISO 13485, ISO 14971, EN 62366-1, and EN 62304."
* Responsible for executing gap assessments of the St. Louis site Quality Management System (QMS) and contribute to the development of policies and procedures that are required to meet the EU MDR requirements.
* As Subject Matter Expert, participate and interface with teams to address and execute the transition of the QMS from the Medical Device Directive to the Medical Device Regulation
* Monitor, track and provide updates relative to EU MDR readiness
* Participate in any compliance activities resulting from the review of technical documentation.
* Excellent written (Technical Writing) and Verbal communication skills
* Ability to identify Compliance Risks related to the Quality Management System requirements
* Ability to translate regulatory requirements into task driven processes and procedures
* Project Management Skills
* Understand gap assessments on Quality Management Systems against EU MDR requirements
* Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
* Organized, efficient, process-oriented; high attention to detail
* Effective interpersonal/communication skills
* Works well cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
* Bachelors in degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology.
* Minimum of 5 years Medical Device experience leading teams in Quality Systems, Compliance or Regulatory
* Firm understanding and prior implementation experience of EU Medical Device Regulations (EU MDR) 2017/145, as well as MDD Directive 93/42/EEC, ISO 13485:2016, ISO 14971:2012, 21CFR820,
Provide the following with each submittal:
Please quantify years with each o f the following:
- MDR 2017/145 and EU Medical Device Regulations
- MDD Directive 93/42/EEC
- ISO 13485:2016
- ISO 14971:2012