Title:
Regulatory Affairs Associate Location:
Temecula, CA(100% Onsite) Duration:
3+Months Shift Time:
9am to 5pm Pay Range:
$20/hr to $24/hr (On W2)
We are looking for a
“Regulatory Affairs Associate”
to join one of our Fortune 500 clients.
Top Skills:
Basic knowledge of US and EU medical device regulatory requirements
Experience supporting OUS/international registrations; experience with change management and regulatory impact assessments
Experience with technical documentation writing
3-4 years regulatory affairs experience with medical devices
Job Responsibilities:
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
Knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals
Education:
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices
Performs a variety of tasks. May lead and direct the work of others.
A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
We are looking for the candidate who are eligible to work with any employers without sponsorship.
If you’re interested, please click
“Apply”
button
#J-18808-Ljbffr
Regulatory Affairs Associate Location:
Temecula, CA(100% Onsite) Duration:
3+Months Shift Time:
9am to 5pm Pay Range:
$20/hr to $24/hr (On W2)
We are looking for a
“Regulatory Affairs Associate”
to join one of our Fortune 500 clients.
Top Skills:
Basic knowledge of US and EU medical device regulatory requirements
Experience supporting OUS/international registrations; experience with change management and regulatory impact assessments
Experience with technical documentation writing
3-4 years regulatory affairs experience with medical devices
Job Responsibilities:
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
Knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals
Education:
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices
Performs a variety of tasks. May lead and direct the work of others.
A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
We are looking for the candidate who are eligible to work with any employers without sponsorship.
If you’re interested, please click
“Apply”
button
#J-18808-Ljbffr