Abbott · 14 hours ago
Regulatory Affairs Associate
Temecula, CA
Contract
Onsite
Mid, Senior Level
3+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Regulatory Affairs Associate will be responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
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
Qualification
Required
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
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
Preferred
May require an advanced degree and 5-8 years of direct experience in the field
Recent experience with Class III implantable medical devices
Benefits
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)
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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