Job Description
Description:
Experience in medical device.
Has a knowledge of ISO 13485, Medical Device Regulations,
More experience with CFR820 med device, help on recall, talking with R&D, speaking with them on daily basis, review validation process, design input, customer input.
CE Mark, class 1, looking for class 1 reusable. Need knowledge for CE Mark
Will not deal with 510k submission or PMA but may by the end of the year.
Daily basis:
Help with process validation before it can be signed, rather than director, Tanya, spot-checking, this person will have the first review. Reading over process and then determining whether or not they fall under regulatory requirements.
May sit down and work through PMA (Post market surveillance) and work with sales people. collecting data from customers.
Regulations:
FDA QSR 820, FDA labeling 803, 810, EU ISO3485, 14971 risk management, CE Mark,
Computer work is very important. Need to have strong attention to detail
Computer programs: Microsoft Office.
Skills:
regulatory, Medical device, MDR, CFR 820, ISO 13485, CE Mark
Top Skills Details:
regulatory, MDR, ISO 13485
Additional Skills & Qualifications:
BS Degree in Sciences
2-3 years experience in regulatory minimum. 5+ preferred
ISO 13485 & FDA QSR 820
Knowledge of CE Marking & the European Medical Device Regulations
Knowledge of design control and design history file
Experience Level:
Intermediate Level
About Aerotek:
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.
