Talent.com
Regulatory Affairs Lead
Regulatory Affairs LeadVirtualVocations • Aloha, Oregon, United States
Regulatory Affairs Lead

Regulatory Affairs Lead

VirtualVocations • Aloha, Oregon, United States
2 days ago
Job type
  • Full-time
Job description

A company is looking for a Regulatory Affairs Lead, IND / IDE.

Key Responsibilities

Advise on regulatory pathways, product classification, and study design considerations

Lead FDA engagement and manage original and maintenance submissions under 21 CFR 312 / 812

Establish and maintain SOPs, mentor regulatory staff, and ensure audit / inspection readiness

Required Qualifications

Advanced degree in a relevant field or equivalent experience

Minimum eight years of progressive regulatory affairs experience with a focus on IND / IDE submissions

Deep knowledge of 21 CFR 312 / 812, ICH-GCP, and familiarity with device quality systems

Experience within an academic medical center or complex research environment

Exceptional technical writing and project management skills

Create a job alert for this search

Regulatory Lead • Aloha, Oregon, United States

Related jobs
Global Regulatory Affairs Leader

Global Regulatory Affairs Leader

VirtualVocations • Aloha, Oregon, United States
Full-time
A company is looking for a Head of Global Regulatory Affairs.Key Responsibilities Define and lead the global regulatory vision and strategy across all categories and geographies Oversee regulato...Show more
Last updated: 3 days ago • Promoted
Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

VirtualVocations • Vancouver, Washington, United States
Full-time
A company is looking for a Sr Manager, Regulatory Affairs.Key Responsibilities Prepare and submit moderately complex regulatory submissions and documents for investigational and commercial produc...Show more
Last updated: 30+ days ago • Promoted
Regulatory Coordinator - MA Licensed

Regulatory Coordinator - MA Licensed

VirtualVocations • Aloha, Oregon, United States
Full-time
A company is looking for a Regulatory Coordinator for Thoracic Oncology.Key Responsibilities Manage compliance and documentation for clinical trials, including IRB submissions and regulatory fili...Show more
Last updated: 4 days ago • Promoted
Travel Nurse - RN - LD - Labor and Delivery - $3281.73 / Week

Travel Nurse - RN - LD - Labor and Delivery - $3281.73 / Week

Host Healthcare • Silverton, OR, US
Full-time
Host Healthcare is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Silverton, OR. Shift : Inquire Start Date : 10 / 22 / 2025 Duration : 13 weeks Pay : $3281...Show more
Last updated: 30+ days ago • Promoted
Regulatory Affairs Manager

Regulatory Affairs Manager

VirtualVocations • Vancouver, Washington, United States
Full-time
A company is looking for a Sr Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote).Key Responsibilities : Guide and coordinate regulatory strategy for labeling, advertising, ...Show more
Last updated: 30+ days ago • Promoted
Regulatory Specialist I

Regulatory Specialist I

VirtualVocations • Aloha, Oregon, United States
Full-time
A company is looking for a Site Activation and Maintenance Associate I.Key Responsibilities Initiate and manage investigator site activities, including regulatory document collection and informed...Show more
Last updated: 2 days ago • Promoted
Local Contract Radiation Therapist

Local Contract Radiation Therapist

Host Healthcare • McMinnville, OR, US
Full-time
Host Healthcare is seeking a local contract Radiation Therapist for a local contract job in McMinnville, Oregon.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 hours...Show more
Last updated: 30+ days ago • Promoted
California Regulatory Affairs Manager

California Regulatory Affairs Manager

VirtualVocations • Aloha, Oregon, United States
Full-time
A company is looking for a Manager of Regulatory Affairs.Key Responsibilities Provide regulatory advice and manage various Regulatory Affairs activities Plan, prepare, coordinate, and submit reg...Show more
Last updated: 3 days ago • Promoted
Travel Nurse - RN - LD - Labor and Delivery - $3638 / Week

Travel Nurse - RN - LD - Labor and Delivery - $3638 / Week

Coast Medical Service • Silverton, OR, US
Full-time
Coast Medical Service is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Silverton, OR. Shift : 4x12 hr nights Start Date : 10 / 22 / 2025 Duration : 13 wee...Show more
Last updated: 30+ days ago • Promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

VirtualVocations • Aloha, Oregon, United States
Full-time
A company is looking for a Product Development & Regulatory Specialist who is passionate about clean, compliant, and innovative beauty. Key Responsibilities Manage and maintain Product Informa...Show more
Last updated: 30+ days ago • Promoted
Licensing Associate - Regulatory

Licensing Associate - Regulatory

VirtualVocations • Salem, Oregon, United States
Full-time
A company is looking for a Licensing Associate - Regulatory & International Licensing.Key Responsibilities Support the end-to-end process of obtaining and maintaining Money Transmitter Licenses (...Show more
Last updated: 3 days ago • Promoted
Travel Nurse - RN - LD - Labor and Delivery - $3400 / Week

Travel Nurse - RN - LD - Labor and Delivery - $3400 / Week

KPG Healthcare Nursing • Silverton, OR, US
Permanent +1
KPG Healthcare Nursing is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Silverton, OR. Shift : Inquire Start Date : ASAP Duration : 13 weeks Pay : $340...Show more
Last updated: 30+ days ago • Promoted
Travel Nurse - Registered Nurse - LD - Labor and Delivery - $3400 / Week

Travel Nurse - Registered Nurse - LD - Labor and Delivery - $3400 / Week

KPG Healthcare Nursing • Silverton, OR, US
Permanent +1
KPG Healthcare Nursing is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Silverton, OR. Shift : Inquire Start Date : ASAP Duration : 13 weeks Pay : $340...Show more
Last updated: 30+ days ago • Promoted
Business Analyst - Regulatory Affairs

Business Analyst - Regulatory Affairs

VirtualVocations • Vancouver, Washington, United States
Full-time
A company is looking for a Business Analyst - ARC (Accelerate Regulatory Capabilities) Submission Planning (Veeva Migration). Key Responsibilities Collaborate with stakeholders to gather, validate...Show more
Last updated: 4 days ago • Promoted
Senior Regulatory Affairs Consultant - Regulatory Lead

Senior Regulatory Affairs Consultant - Regulatory Lead

Parexel • Salem, OR, US
Full-time
Join Parexel as a Regulatory Affairs Strategy Lead.Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs? Do you thrive in cross-functional enviro...Show more
Last updated: 5 days ago • Promoted
Regulatory Readiness Program Manager

Regulatory Readiness Program Manager

Legacy Health • Portland, OR, US
Full-time
Regulatory Readiness Program Manager.This is a hybrid role that is highly consultative and has regular meetings at a variety of Legacy locations across the Portland Metro area.On days that onsite a...Show more
Last updated: 30+ days ago • Promoted
Regulatory Affairs Lead

Regulatory Affairs Lead

VirtualVocations • Vancouver, Washington, United States
Full-time
A company is looking for a Regulatory Affairs Lead, IND / IDE.Key Responsibilities Advise on regulatory pathways, product classification, and study design considerations Lead FDA engagement and ma...Show more
Last updated: 2 days ago • Promoted
Travel Radiation Oncology Therapist

Travel Radiation Oncology Therapist

Anders Group • McMinnville, OR, US
Full-time
Anders Group is seeking a travel Radiation Therapist for a travel job in McMinnville, Oregon.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 hours per week (subject ...Show more
Last updated: 9 days ago • Promoted
US Regulatory Policy Director

US Regulatory Policy Director

VirtualVocations • Aloha, Oregon, United States
Full-time
A company is looking for a Director, US Regulatory Intelligence & Policy Lead.Key Responsibilities Lead the acquisition, analysis, communication, and management of US regulatory intelligence Dev...Show more
Last updated: 9 days ago • Promoted
Local Contract Radiation Oncology Therapist

Local Contract Radiation Oncology Therapist

Host Healthcare • McMinnville, OR, US
Full-time
Host Healthcare is seeking a local contract Radiation Therapist for a local contract job in McMinnville, Oregon.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 hours...Show more
Last updated: 9 days ago • Promoted