Abbott · 11 hours ago
Regulatory Affairs Associate
Santa Clara, CA
Contract
Onsite
Senior Level
5+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Regulatory Affairs Associate is responsible for managing and executing regulatory activities for Class III implantable medical devices, leading the preparation and submission of regulatory documents while serving as a key liaison with government agencies such as the FDA.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Prepare, author, and submit PMA supplements, including: 30-Day Notices, Real-Time Reviews,180-Day Supplements, Annual Reports
Serve as the primary regulatory contact for all government interactions related to product approvals and post-approval changes
Review and approve engineering study protocols and reports
Review and approve validation study protocols and reports
Review, assess, and approve manufacturing changes for Class III implantable medical devices
Ensure compliance with FDA PMA guidance documents, CFR regulations, and applicable standards
Provide regulatory strategy and guidance to support product lifecycle management
Lead and direct regulatory activities for assigned projects, ensuring timely submissions and approvals
Collaborate cross-functionally with engineering, quality, manufacturing, and clinical teams
Maintain accurate regulatory documentation and ensure audit readiness
Apply expert judgment to plan, prioritize, and accomplish regulatory objectives
May lead, mentor, and direct the work of other regulatory staff
Qualification
Required
Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, or related field (advanced degree preferred)
5–8 years of direct regulatory affairs experience, with recent hands-on experience in Class III implantable medical devices
Proven success authoring, submitting, and obtaining approval for Class III PMA supplements
In-depth knowledge of FDA PMA processes
In-depth knowledge of FDA guidance documents
In-depth knowledge of CFR regulations applicable to Class III devices
Strong understanding of engineering and validation documentation review
Preferred
Master's degree or higher in a relevant scientific or regulatory discipline
Experience leading regulatory strategy for complex or high-risk medical devices
Prior experience mentoring or managing regulatory team members
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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