EU MDR Project Manager
Exton, PA · Remote
$83K - $167K/yr
Understanding of Clinical Evaluations and EU MDR compliance
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Exton, PA · Remote
$83K - $167K/yr
Understanding of Clinical Evaluations and EU MDR compliance
Quick apply
Exton, PA · Remote
$83K - $167K/yr
Understanding of Clinical Evaluations and EU MDR compliance
Exton, PA · Remote
$83K - $167K/yr
Must have Medical Device Experience within EU MDD and/or EU MDR 1. Coordinate the defined cadence of the EU MDR program work for claims with other copy review workstreams such as active CAPAs. When ...
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Exton, PA · Remote
$83K - $167K/yr
Must have Medical Device Experience within EU MDD and/or EU MDR 1. Coordinate the defined cadence of the EU MDR program work for claims with other copy review workstreams such as active CAPAs. When ...
Exton, PA · Remote
$83K - $167K/yr
Must have Medical Device Experience within EU MDD and/or EU MDR 1. Coordinate the defined cadence of the EU MDR program work for claims with other copy review workstreams such as active CAPAs. When ...
Quick apply
Exton, PA · Remote
$83K - $167K/yr
Must have Medical Device Experience within EU MDD and/or EU MDR 1. Coordinate the defined cadence of the EU MDR program work for claims with other copy review workstreams such as active CAPAs. When ...
Exton, PA · Remote
$83K - $167K/yr
Understanding of Clinical Evaluations and EU MDR compliance
Quick apply
Exton, PA · Remote
$83K - $167K/yr
Understanding of Clinical Evaluations and EU MDR compliance
Support EU MDR remediation projects for orthopedic medical device products. * Review, update, and maintain Design History Files (DHFs) and technical documentation. * Perform design assurance ...
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Support EU MDR remediation projects for orthopedic medical device products. * Review, update, and maintain Design History Files (DHFs) and technical documentation. * Perform design assurance ...
$150K - $198K/yr
CE Mark submissions under EU MDR (2017/745), including Technical Documentation * International regulatory submissions (e.g., Health Canada, TGA) * Serve as primary contact with regulatory authorities ...
$150K - $198K/yr
CE Mark submissions under EU MDR (2017/745), including Technical Documentation * International regulatory submissions (e.g., Health Canada, TGA) * Serve as primary contact with regulatory authorities ...
Middleton, WI · On-site
$150K - $198K/yr
CE Mark submissions under EU MDR (2017/745), including Technical Documentation * International regulatory submissions (e.g., Health Canada, TGA) * Serve as primary contact with regulatory authorities ...
Middleton, WI · On-site
$150K - $198K/yr
CE Mark submissions under EU MDR (2017/745), including Technical Documentation * International regulatory submissions (e.g., Health Canada, TGA) * Serve as primary contact with regulatory authorities ...
Atlanta, GA · Remote
$99 - $100/hr
Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll * Demonstrated ability to work independently as a contractor in a fast-paced environment
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Atlanta, GA · Remote
$99 - $100/hr
Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll * Demonstrated ability to work independently as a contractor in a fast-paced environment
Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and ...
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Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and ...
Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and ...
Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and ...
Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and ...
Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and ...
The position is to support the European Union Medical Device Regulation (EU MDR) program at Integra Añasco, PR. The incumbent will be supporting the following activities to ensure conformance with ...
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The position is to support the European Union Medical Device Regulation (EU MDR) program at Integra Añasco, PR. The incumbent will be supporting the following activities to ensure conformance with ...
We are seeking an experienced Project Manager to lead the implementation of European Union Medical Device Regulation (EU MDR) requirements at our Arlington manufacturing site. This role will be ...
We are seeking an experienced Project Manager to lead the implementation of European Union Medical Device Regulation (EU MDR) requirements at our Arlington manufacturing site. This role will be ...
Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and ...
Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and ...
The EU MDR project manager will lead the team in development and execution of the project management plan, identifies risks and mitigation strategies, and keeps stakeholders updated on progress.
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The EU MDR project manager will lead the team in development and execution of the project management plan, identifies risks and mitigation strategies, and keeps stakeholders updated on progress.
San Clemente, CA · On-site
$32 - $37/hr
Ensure compliance with FDA regulations, ISO 13485, ISO 14971, EU MDR 2017/745, and quality system requirements. * Support audits, inspections, and continuous quality improvement initiatives.
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San Clemente, CA · On-site
$32 - $37/hr
Ensure compliance with FDA regulations, ISO 13485, ISO 14971, EU MDR 2017/745, and quality system requirements. * Support audits, inspections, and continuous quality improvement initiatives.
EU MDR and/or UK MDR * Preferred: Practical experience working with software. * Auditing experience * Prior work with notified bodies or accreditation bodies as a Lead Auditor * Technical experience
EU MDR and/or UK MDR * Preferred: Practical experience working with software. * Auditing experience * Prior work with notified bodies or accreditation bodies as a Lead Auditor * Technical experience
Anasco, PR · On-site
$35/hr
The position is to support the European Union Medical Device Regulation (EU MDR) program at Añasco, PR. The incumbent will be supporting the following activities to ensure conformance with EU MDR ...
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Anasco, PR · On-site
$35/hr
The position is to support the European Union Medical Device Regulation (EU MDR) program at Añasco, PR. The incumbent will be supporting the following activities to ensure conformance with EU MDR ...
$40 - $46/hr
S PMA supplements (30-day Notices, Real-Time Reviews, 180-Day Supplements, Annual Reports), as well as supporting EU MDR Technical Documentation updates, change assessments, and Notified Body ...
$40 - $46/hr
S PMA supplements (30-day Notices, Real-Time Reviews, 180-Day Supplements, Annual Reports), as well as supporting EU MDR Technical Documentation updates, change assessments, and Notified Body ...
Contractor Key Responsibilities: 1. Develop and lead global regulatory strategies for cosmetic and borderline products, ensuring alignment with FDA, EU MDR, and other international requirements. 2. ...
Contractor Key Responsibilities: 1. Develop and lead global regulatory strategies for cosmetic and borderline products, ensuring alignment with FDA, EU MDR, and other international requirements. 2. ...
$45K - $51.7K
1% of jobs
$51.7K - $58.5K
3% of jobs
$58.5K - $65.2K
7% of jobs
$65.2K - $71.9K
13% of jobs
$72.2K is the 25th percentile. Wages below this are outliers.
$71.9K - $78.6K
18% of jobs
The median wage is $81.4K / yr.
$78.6K - $85.4K
19% of jobs
$90.9K is the 75th percentile. Wages above this are outliers.
$85.4K - $92.1K
17% of jobs
$92.1K - $98.8K
9% of jobs
$98.8K - $105.5K
6% of jobs
$105.5K - $112.3K
4% of jobs
$112.3K - $119K
2% of jobs
$45K
$84K
$119K
To excel as an EU MDR (European Union Medical Device Regulation) Specialist, you need expertise in regulatory compliance, medical device standards, and a relevant degree such as in engineering, life sciences, or a related field. Familiarity with regulatory submission software, ISO 13485 quality management systems, and certification as a Regulatory Affairs Professional (RAPS) is highly beneficial. Strong analytical thinking, attention to detail, and effective cross-functional communication skills help you stand out in this role. These abilities are crucial for ensuring that medical devices meet the strict EU MDR requirements, maintaining patient safety, and achieving ongoing market access for products.
A EU MDR job involves ensuring compliance with the European Union Medical Device Regulation (EU MDR), which governs the safety and performance of medical devices in the EU market. Professionals in this role work on regulatory submissions, post-market surveillance, risk management, and quality assurance. They help medical device companies navigate regulatory requirements to achieve and maintain product certification. This role often requires knowledge of regulatory standards, clinical evaluation processes, and technical documentation.
As an EU MDR Specialist, your primary responsibilities include interpreting and implementing the evolving regulatory requirements of the EU MDR for medical devices, preparing comprehensive technical documentation, and facilitating regulatory submissions. You may regularly coordinate with product development, quality assurance, and clinical teams to ensure compliance throughout the device lifecycle. One of the main challenges in this role is staying current with complex, frequently updated regulations while meeting tight deadlines. Effective collaboration and adaptability are essential, as the work often involves cross-disciplinary teamwork and responding quickly to regulatory changes or audits.

$83K - $167K/yr
Contractor
Medical, Dental, Vision
Re-posted 19 days ago
We are looking for a team member who is highly organized, timely and has excellent communication skills
You will be responsible for planning, coordinating, and implementing projects within the decided-upon budget, timeline, and scope. You will also effectively monitor and present project updates to relevant stakeholders, clients, or project team members
This is a high visibility, tight-timeline project so we are looking for folks who are able to manage their own time as well as keep things on track for the teams
Must have experience within a highly regulated industry Medical Device or Pharmaceuticals
Must have a solid understanding of CERs within EU MDD MDR compliance
Responsibilities
Qualifications