Regulatory Affairs Associate
Abbott, Los Angeles, CA, United States
Regulatory Affairs Associate
Location: Sylmar, CA
Duration: 8 Months
100% Onsite
Summary
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.
May require an advanced degree and 5‑8 years of direct experience in the field.
Recent experience with 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.
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.
Consultants Eligible Benefits Upon Waiting Period
Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High‑Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
401(k)
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Duration: 8 Months
100% Onsite
Summary
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.
May require an advanced degree and 5‑8 years of direct experience in the field.
Recent experience with 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.
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.
Consultants Eligible Benefits Upon Waiting Period
Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High‑Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
401(k)
#J-18808-Ljbffr