Regulatory Affairs Manager Job at BioTalent, Irvine, CA

d1V6RGxyN0pNUmZ3a010YjZkVzVuTDcxeHc9PQ==
  • BioTalent
  • Irvine, CA

Job Description

Regulatory Affairs Manager (Hybrid Preferred)

📍 Location: Irvine, CA | 💼 Full-time | 🏥 Medical Device Industry

Join a passionate, mission-driven team dedicated to advancing medical device innovation and improving patient outcomes. As a Regulatory Affairs Manager , you will play a key role in coordinating and preparing regulatory submissions, partnering with cross-functional teams, and ensuring compliance with global regulatory standards. This role offers the opportunity to apply your expertise in a collaborative environment while directly contributing to life-saving technologies.

What You’ll Do

  • Develop and implement complex, global regulatory strategies for new and modified devices.
  • Prepare, review, and submit regulatory documentation for the U.S. and international markets.
  • Serve as the regulatory representative on multi-disciplinary project teams, aligning regulatory strategy with business objectives.
  • Interact with FDA, Notified Bodies, and international authorities throughout the device lifecycle.
  • Review product changes, labeling, advertising, and promotion for compliance with applicable regulations.
  • Support ongoing product maintenance, license renewals, and annual registrations.
  • Provide regulatory guidance during audits, inspections, and SOP development.
  • Consolidate and maintain communication with regulatory agencies and cross-functional stakeholders.

What We’re Looking For

  • Bachelor’s degree in a scientific, technical, or related field (advanced degree preferred).
  • 5–8 years of regulatory affairs experience in the medical device industry, preferably with Neurovascular or Cardiovascular Devices
  • Hands-on experience with U.S. and EU submissions, including HDE, IDE, and PMA applications .
  • Strong background in writing, project management, and regulatory coordination.
  • Proven experience interfacing with regulatory authorities through all stages of the product lifecycle.
  • Ability to thrive in a fast-paced, deadline-driven environment with cross-functional collaboration.
  • Proficiency with MS Office and Adobe Acrobat.

Job Tags

Full time,

Similar Jobs

Belcan

Facility Technician Job at Belcan

 ...Job Title: Facility Technician Location: Myerstown, PA Zip Code: 17067 Duration: 12months...  ..., communication skills, and skills to build a team-oriented culture (i.e. training team...  ...skills in English required. * Good PC Skills, including use of e-mail, attaching... 

Mpowering People

Manufacturing Supervisor - 2nd Shift Job at Mpowering People

 ...~3+ years of supervisory experience in a manufacturing or assembly setting. ~ Bachelors degree preferred but not mandatory. ~ Solid understanding of manufacturing systems, procedures, and quality standards. ~ Familiar with lean manufacturing, Six Sigma, or similar... 

Confidential

Recruiter Job at Confidential

 ...reviews Serve as contact person for questions from candidates Meet weekly quotas related to calls and emails High Volume Recruiting Qualifications Bachelor's degree Effective communication skills Strong organizational and interpersonal skills... 

Air Distribution Technologies, Inc.

Senior Business Analyst Job at Air Distribution Technologies, Inc.

 ...As part of the product team, the Senior Business/Product Analyst will play an important role in empowering the business to make data...  ...major company initiatives from defining and monitoring product performance metrics to ensuring the best decisions are made in product... 

GovGig

Quality Control Manager Job at GovGig

 ...The Quality Control Manager (QCM) is responsible for overseeing and enforcing the quality standards for federal construction projects, with a focus on electrical work . The QCM ensures compliance with the Three-Phase Control System as required by USACE, NAVFAC, and...