Overview
Job Summary
The Senior Regulatory Affairs Specialist is responsible for managing and executing regulatory activities for Class III implantable medical devices that require governmental approval. This role leads the preparation, submission, and approval of Premarket Approval (PMA) supplements and serves as a key regulatory liaison with government agencies, including the FDA. The position requires extensive regulatory expertise, independent judgment, and the ability to guide cross-functional teams through complex regulatory pathways.
Details Title:
Regulatory Affairs Associate
Location:
Santa Clara, California
Duration:
3 Months (100% Onsite)
Key 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.
Required Qualifications
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
FDA guidance documents
CFR regulations applicable to Class III devices
Strong understanding of engineering and validation documentation review.
Preferred Qualifications
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.
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)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
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The Senior Regulatory Affairs Specialist is responsible for managing and executing regulatory activities for Class III implantable medical devices that require governmental approval. This role leads the preparation, submission, and approval of Premarket Approval (PMA) supplements and serves as a key regulatory liaison with government agencies, including the FDA. The position requires extensive regulatory expertise, independent judgment, and the ability to guide cross-functional teams through complex regulatory pathways.
Details Title:
Regulatory Affairs Associate
Location:
Santa Clara, California
Duration:
3 Months (100% Onsite)
Key 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.
Required Qualifications
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
FDA guidance documents
CFR regulations applicable to Class III devices
Strong understanding of engineering and validation documentation review.
Preferred Qualifications
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.
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)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
#J-18808-Ljbffr