Regulatory Affairs Specialist-Post Market Vigilance
Quick Apply Full-time Temporary Contract 1 hour ago Full Job Description Maven Wise, LLC is recruiting for a Regulatory Affairs Specialist with a focus on post- market vigilance.
This is a fully remote opportunity with a globally recognized medical devices manufacturer.
You will be providing support to ensure compliance for worldwide regulatory reporting requirements.
Here's your day to day:
Review cases for regulatory reporting from the complaint handling system Create and maintain regulatory reports to comply with worldwide regulatory requirements including EU MDR Regulations Review, create and close reporting of adverse events (MDRs and Vigilance).
Assist in Post Market Compliance activities as necessary.
Collaborate effectively on regulatory projects with individuals at all levels within the business Participate in fulfilling the request from regulatory bodies or distributors to support submission worldwide.
Ensure compliance with post-market approval requirements Your
Qualifications:
Bachelor's in Science or Scientific discipline 2
years of experience in regulatory affairs within the medical devices industry (plus) Excellent interpersonal/communication (oral and written) Ability to work with cross-functional teams Experience in SAP or Oracle, MS Suite Job Types:
Full-time, Contract, Temporary Pay:
$42.
00 per hour
Benefits:
401(k) Schedule:
Monday to Friday Work Location:
Remote Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
This is a fully remote opportunity with a globally recognized medical devices manufacturer.
You will be providing support to ensure compliance for worldwide regulatory reporting requirements.
Here's your day to day:
Review cases for regulatory reporting from the complaint handling system Create and maintain regulatory reports to comply with worldwide regulatory requirements including EU MDR Regulations Review, create and close reporting of adverse events (MDRs and Vigilance).
Assist in Post Market Compliance activities as necessary.
Collaborate effectively on regulatory projects with individuals at all levels within the business Participate in fulfilling the request from regulatory bodies or distributors to support submission worldwide.
Ensure compliance with post-market approval requirements Your
Qualifications:
Bachelor's in Science or Scientific discipline 2
years of experience in regulatory affairs within the medical devices industry (plus) Excellent interpersonal/communication (oral and written) Ability to work with cross-functional teams Experience in SAP or Oracle, MS Suite Job Types:
Full-time, Contract, Temporary Pay:
$42.
00 per hour
Benefits:
401(k) Schedule:
Monday to Friday Work Location:
Remote Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
