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Eu Mdr Project Manager Jobs (NOW HIRING)

JenaValve

Project Manager, Regulatory Affairs

Irvine, CA · On-site

$130K - $140K/yr

Job Title : Project Manager, Regulatory Affairs Supervisor/Manager Title: Senior Manager ... Experience with EU MDR implementation preferred. * Comprehensive knowledge of quality systems and ...

QT Imaging, Inc.

Senior QA/RA Specialist

Novato, CA · On-site

$96K - $133K/yr

... Management System in alignment with FDA QMSR, ISO 13485, EU MDR, and other applicable global ... Serve as the primary QA/RA representative on cross-functional project teams, ensuring quality and ...

atrion

Quality Engineering Manager

Davie, FL · On-site

... management, project management, internal & external auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA)

CYNET SYSTEMS

Regulatory Affairs Associate

Sylmar, CA · On-site

$40 - $45/hr

Exposure to authoring and/or supporting PMA supplements and familiarity with EU MDR (2017/745 ... Typically reports to a manager or head of a unit/department. Founded in 2010 and headquartered in ...

Staffingine LLC

Oracle Business Analyst

San Diego, CA · On-site

$63.75 - $87.75/hr

... EU MDR GMP * 6 Collaboration Change Management * Partner with stakeholders manufacturing supply ... Collaborate with Project Managers Engineering and IT to ensure requirements align to program ...

Scarlet

Lead Auditor - Contractor role

Conduct remote audits of medical device manufacturers' Quality Management Systems under ISO 13485, EU MDR, and UK MDR. * Provide clear, structured audit documentation and evidence-based conclusions.

Elucid

Director of Regulatory

Boston, MA · On-site

$175K - $225K/yr

You'll lead the execution of our regulatory strategy across FDA, EU MDR and other international markets, guiding submissions from pre-sub through post-market lifecycle management for a quickly ...

Elucid

Director of Regulatory

Boston, MA · On-site

You'll lead the execution of our regulatory strategy across FDA, EU MDR and other international markets, guiding submissions from pre-sub through post-market lifecycle management for a quickly ...

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Eu Mdr Project Manager information

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$51.5K

$112.3K

$170K

How much do eu mdr project manager jobs pay per year?

As of Sep 13, 2026, the average yearly pay for eu mdr project manager in the United States is $112,336.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,500.00 and $130,500.00 per year, depending on experience, location, and employer.

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Infographic showing various Eu Mdr Project Manager job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 80% Physical, 2% Hybrid, and 18% Remote job distribution, with an average salary of $112,336 per year, or $54 per hour.

Regulatory Affairs Specialist

Garland, TX • On-site

Theragenics Corp
201 - 500 employees
Learn more about Theragenics Corpexternal

Full-time

Posted 23 days ago

Key responsibilities

  • Coordinate the preparation, assembly, and submission of regulatory documents such as 510(k)s, Technical Files, and product registrations.

  • Partner with cross-functional teams to ensure compliance with international regulations and maintain regulatory files.

  • Support internal and external audits related to regulatory compliance and assist in maintaining successful audit outcomes.

Job description

At Theragenics, we're passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what's possible, ensuring a brighter future for patients everywhere. Theragenics is a leader in developing medical devices that focus on minimally invasive treatments for cancer, blood vessel procedures, and surgical applications. The company is based in Atlanta, Georgia, and has facilities in Costa Rica, Texas, and Massachusetts. Theragenics proudly operates Arrotek, a visionary medical device design consultancy in the U.S. and Ireland, dedicated to pioneering minimally invasive solutions that enhance lives.

Note: This is a hybrid position.

Role Summary

As a Regulatory Affairs Specialist, you’ll play a pivotal role in driving global regulatory compliance and product submissions, collaborating with cross-functional teams to deliver cutting-edge solutions in medical device regulatory affairs across domestic and international markets.

Key Responsibilities

  • Regulatory Compliance: Partner with Quality, Engineering, Operations, and Document Control to ensure business compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR, MDSAP, and applicable international regulations.

  • Regulatory Submissions: Coordinate the preparation, assembly, and submission of 510(k)s, Technical Files, Letters to File, Product Registrations, and international market registrations to obtain approvals for product development, clinical trials, and marketing authorizations.

  • Documentation & Audits: Prepare, review, and submit regulatory documents, maintain up-to-date regulatory files, conduct internal audits, and support customer and regulatory agency audits as needed.

  • Global Strategy & Guidance: Stay abreast of evolving global regulatory requirements, provide regulatory guidance to project teams, and facilitate communication between internal stakeholders, notified bodies, and regulatory authorities.

  • QMS Support: Offer support in Quality Management System (QMS) operations, including surveillance, reporting, and label approvals as necessitated.

Qualifications & Skills

Required Qualifications:

  • Bachelor’s degree in a science or engineering field (such as biology, chemistry, or pharmacy).

  • 3 to 5 years of working experience in a regulated field like clinical research or medical manufacturing.

  • Experience working with international manufacturing locations.

  • Direct working experience with FDA regulations, EU MDR, and MDSAP.

  • Bilingual fluency in both English and Spanish (written and verbal).

Preferred Qualifications:

  • Advanced degree in a related science or engineering field.

  • Experience with Class II and/or Class III medical devices.

  • Experience supporting manufacturing operations in Latin America.

  • Regulatory Affairs Certification (RAC) and/or Regulatory Affairs Professionals Society (RAPS) membership.

Success Measures

Within the first 12 months, the successful candidate will:

  • Significantly progress EU MDR submissions.

  • Identify post-submission continuous improvement actions.

  • Maintain successful FDA, ISO, and customer audit outcomes with no critical findings.

Why Join Us

  • Purpose-driven work: Directly contribute to the approval and delivery of life-changing medical technologies.

  • Innovative projects: Engage with complex global markets, EU MDR initiatives, and class-leading medical devices.

  • Collaborative culture: Work side-by-side with cross-functional teams spanning quality, engineering, and international operations.

  • Career growth: Expand your regulatory expertise across multiple global jurisdictions and regulatory frameworks.

  • Competitive benefits: Enjoy a comprehensive total rewards package designed to support you and your family.


Ready to make a difference? Apply today and be part of something extraordinary.

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