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Regulatory Affairs Specialist

The Panther Group

Torrance, CA

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JOB DETAILS
SALARY
SKILLS
Auditing, Change Control, Code of Federal Regulations, Communication Skills, Cross-Functional, Documentation, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Manufacturing, Manufacturing Operations, Medical Equipment, Medical Office Administration, Medical Products, Organizational Skills, Product Reviews, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Risk Management, Technical Writing, Technical/Engineering Design
LOCATION
Torrance, CA
POSTED
30+ days ago
Regulatory Affairs Specialist

Salary: $120,000–$150,000+ (Depending on Experience)

We are seeking an experienced Regulatory Affairs Specialist to support medical device compliance, regulatory documentation, and quality system activities for Class I and Class II medical devices.

This is a highly visible, hands-on role where you'll work closely with Engineering, Quality, Manufacturing, and Operations to ensure products meet FDA, ISO 13485, and customer regulatory requirements. If you enjoy working in a fast-paced manufacturing environment and want to make a direct impact, we'd love to hear from you.
What You'll Do
  • Support regulatory compliance activities for medical device products
  • Maintain technical documentation, Design History Files (DHFs), and Device Master Records (DMRs)
  • Review product labeling, procedures, specifications, and quality records
  • Support change control, risk management, audit readiness, and regulatory submissions
  • Assist with FDA, ISO 13485, EU MDR, and customer compliance requirements
  • Partner with cross-functional teams to ensure regulatory requirements are met
What We're Looking For
  • Bachelor's degree in a technical or related field
  • 8+ years of Regulatory Affairs, Quality, or Compliance experience in a medical device environment
  • Strong knowledge of FDA 21 CFR Part 820 and ISO 13485
  • Experience with Class I medical devices required
  • Experience with Class II devices, 510(k) submissions, EU MDR, or ISO 14971 is highly preferred
  • Strong communication, documentation, and organizational skills
Interview Process
  1. Teams Interview
  2. Onsite Panel Interview and Facility Tour

Please Note: This is an on-site position and is not eligible for remote or hybrid work.

About the Company

T

The Panther Group

The Panther Group is minority owned and certified, making diversity, equity and inclusion core components of our mission.

With our commitment to respecting and empowering our employees as individuals, diversity is a competitive advantage in the marketplace.

The Panther Group has a proven track record of connecting quality talent with the right position. We believe in a hands-on approach, with a focus on building lasting relationships with our Employees and our Clients. Our Employees find flexibility and growth to reach their career goals.

The Panther Group celebrates 25 years of recruitment and workforce solutions expertise. 

COMPANY SIZE
20 to 49 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1992
WEBSITE
http://thepanthergrp.com