BioTalent
Overview
This regulatory role supports a mission-driven team focused on advancing medical device innovation and improving patient outcomes. As a
Regulatory Affairs Manager , you will coordinate regulatory submissions, partner with cross-functional teams, and ensure compliance with global regulatory standards. This role offers the opportunity to apply your expertise in a collaborative environment while contributing to life-saving technologies. Base pay range: $160,000.00/yr - $180,000.00/yr Additional compensation types : Annual Bonus 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 Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal and Writing/Editing Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at BioTalent by 2x. Get notified about new Regulatory Affairs Manager jobs in
Irvine, CA . Irvine, CA $160,000.00-$180,000.00 We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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This regulatory role supports a mission-driven team focused on advancing medical device innovation and improving patient outcomes. As a
Regulatory Affairs Manager , you will coordinate regulatory submissions, partner with cross-functional teams, and ensure compliance with global regulatory standards. This role offers the opportunity to apply your expertise in a collaborative environment while contributing to life-saving technologies. Base pay range: $160,000.00/yr - $180,000.00/yr Additional compensation types : Annual Bonus 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 Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal and Writing/Editing Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at BioTalent by 2x. Get notified about new Regulatory Affairs Manager jobs in
Irvine, CA . Irvine, CA $160,000.00-$180,000.00 We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr