Aerotek Chemist (Regulatory Compliance) in Minneapolis, Minnesota
This chemist supports EU MDR Remediation activities in order to improve the company's regulatory compliance position. This chemist will assist in the gap assessment of technical documentation for EU Medical Device Regulation compliance activities across company product portfolio. They will be an integral team member on the Technical Documentation EU MDR Workstream Team in order to update or prepare technical documentation to reconcile product technical files.
The products that they would be remediating are 4 for different chemical solutions used to clean their devices. This role is part lab, but mostly computer based and can be done remotely.
RESPONSIBILITIES: • Prepare, author, and edit technical documentation required to meet the EU MDR requirements. • Review and understand global regulatory requirements (FDA, EU MDD, MDR, Health Canada, etc.) with emphasis on EU MDR 2017/745. • Collaborate with cross-functional teams to prepare related technical documentation for Change Order publication and approval • Prepare and/or Author QP’s (Qualification Protocols), ECO’s (Engineering Change Orders), BOM’s (Bills of Material), Component Spec Sheets, and Item masters, for entry into documentation system into order to build technical documentation for the device. • Supports in providing information for quotations on custom test applications to support gaps identified in technical documentation. (Including test specifications, drawings, scope, labor hours, equipment costs, lead times, schedules and out-sourcing services) • Develop test plans, test strategies and test sequences to collect relevant performance data required for EU MDR technical documentation • Interfaces with internal customers, and external vendors to provide a technical support for EU MDR related documentation.
autoclave, qa/qc, chemistry, Chemicals, remediation project, regulatory compliance, medical device
Top Skills Details:
Chemistry Documentation Remediation
Additional Skills & Qualifications:
Bachelor's degree in Chemistry (strongly preferred) but open to other science degrees 0-3 years of lab experience (can be from college) Detail oriented Team mentality (verified by references)
There is a strong preference to candidates that can start sooner rather than later as their work is adding up!
Qualities they want to see: team players, time management, any sort of technical writing experience, experience with Microsoft word and Excel.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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