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Commission Eu Mdr Jobs (NOW HIRING)

Philips

Regulatory Affairs Specialist I

San Diego, CA · On-site

$71K - $112K/yr

You have familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international ... In addition, other compensation, such as an annual incentive bonus, sales commission or long-term ...

Philips

Regulatory Affairs Specialist I

Bedford, MA · On-site

$71K - $112K/yr

You have familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international ... In addition, other compensation, such as an annual incentive bonus, sales commission or long-term ...

Philips

Regulatory Affairs Specialist I

Bedford, MA · On-site

$71K - $112K/yr

You have familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international ... In addition, other compensation, such as an annual incentive bonus, sales commission or long-term ...

Philips

Regulatory Affairs Specialist I

Plymouth, MN · On-site

$71K - $112K/yr

You have familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international ... In addition, other compensation, such as an annual incentive bonus, sales commission or long-term ...

Apple

Senior Lead Auditor - Medical Devices

Cupertino, CA

$149K - $249K/yr

ISO 13485, MDSAP requirements, China GMP, EU MDR, China GMP, etc...) Excellent written and verbal ... Additionally, this role might be eligible for discretionary bonuses or commission payments as well ...

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Commission Eu Mdr information

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$42K

$94.9K

$155K

How much do commission eu mdr jobs pay per year?

As of Aug 5, 2026, the average yearly pay for commission eu mdr in the United States is $94,924.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,000.00 and $108,000.00 per year, depending on experience, location, and employer.

What is the difference between Commission Eu Mdr vs Notified Body Auditor?

AspectCommission Eu MdrNotified Body Auditor
CertificationsRequires knowledge of EU MDR regulations and CE marking processesRequires certification in auditing and conformity assessment procedures
Work EnvironmentRegulatory agencies, policy development, compliance oversightOn-site audits at manufacturing facilities, documentation review
Employer & Industry UsageEuropean Commission, regulatory bodies, medical device industryNotified bodies, certification agencies, medical device manufacturers

In summary, the Commission Eu Mdr focuses on developing and overseeing EU medical device regulations, while a Notified Body Auditor conducts assessments to ensure compliance with these regulations. Both roles are essential in the medical device industry but differ in responsibilities and work environment.

What are some common challenges faced when working as a Commission EU MDR specialist, and how can applicants best prepare for them?

One of the primary challenges in a Commission EU MDR (Medical Device Regulation) specialist role is keeping up with frequent regulatory updates and ensuring company compliance across multiple markets. Applicants should be prepared to interpret complex legal documents, coordinate with cross-functional teams (such as R&D, quality assurance, and legal), and manage detailed documentation. Strong project management skills and attention to detail are essential, as deadlines for regulatory submissions can be tight. Proactively staying informed about new EU MDR developments and building collaborative relationships within your organization will help you succeed in this dynamic environment.

What is a Commission EU MDR?

The Commission EU MDR refers to the European Union Medical Device Regulation (EU MDR), which is a set of regulations established by the European Commission to ensure the safety and performance of medical devices sold within the EU. The MDR replaces the older Medical Devices Directive (MDD) and introduces stricter requirements for manufacturers, importers, and distributors of medical devices. It covers everything from clinical evaluation to post-market surveillance and labeling. Compliance with the MDR is mandatory for companies wishing to market medical devices in the European Economic Area.

What are the key skills and qualifications needed to thrive as a Commission EU MDR specialist?

To thrive as a Commission EU MDR (Medical Device Regulation) specialist, you need a deep understanding of EU regulatory frameworks, medical device compliance, and typically a background in life sciences or engineering. Familiarity with regulatory submission systems, risk management tools like ISO 14971, and relevant certifications such as Regulatory Affairs Certification (RAC) are highly valuable. Strong attention to detail, analytical thinking, and effective communication are crucial soft skills for interpreting regulations and liaising with stakeholders. These skills ensure that medical devices meet stringent EU standards, supporting patient safety and successful market access.
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Commission Eu Mdr jobs near you
Infographic showing various Commission Eu Mdr job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 80% Full Time, 10% Part Time, and 9% Contract. Highlights an 88% Physical, 1% Hybrid, and 11% Remote job distribution, with an average salary of $94,924 per year, or $45.6 per hour.

Regulatory Affairs Specialist

Charter Medical

Winston Salem, NC • On-site

Full-time

Medical, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

Job description

What we are looking for:

Plans, organizes and implements strategies and activities required to procure regulatory approval for new and revised product lines. 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 international requirements and company policies and procedures regarding submissions and other requirements for market approval of medical devices.

1st Shift: Monday-Friday 8:00 am-5:00 pm

What you will do:

Regulatory Submissions & Approvals

  • Authors, compiles, and submits regulatory documents to obtain approval to market new or modified products, including 510(k) premarket notifications and international submissions.
  • Prepares , maintains and submits Technical Documentation and Declarations of Conformity for CE-marked products under EU MDR 2017/745.
  • Prepares and maintains international product registrations.
  • Prepares and updates US FDA product listings and establishment registrations.

Regulatory Intelligence & Compliance

  • Monitors publications and activities of FDA, EU Commission, and international regulatory bodies to identify and respond to new or revised regulatory requirements affecting company products.
  • Interprets existing and emerging regulatory requirements as they relate to company products and procedures; communicates updates to appropriate personnel and management.
  • Identifies and communicates changes to domestic and international regulatory requirements in a timely manner to support proactive compliance planning.
  • Ensures label claims and content of promotional and marketing materials comply with domestic and international regulatory requirements; reviews and recommends appropriate changes.

Product Development & Change Assessment

  • Provides regulatory support to new product development teams to ensure US and international regulatory requirements are incorporated into the development process from design input through commercialization.
  • Performs and documents regulatory assessments for modifications to existing devices, collaborating with marketing, R&D, and operations on proposed changes.
  • Supports marketing and new product development in regulatory assessments of proposed labeling, design, or manufacturing changes.
  • Collaborates with engineering and operations teams on design controls, validation activities, and technology transfers.

Who you are:

  • Bachelor’s degree or higher in a life science, engineering, or related discipline from an accredited institution.
  • Minimum of 3–5 years of regulatory affairs experience in the medical device industry.
  • Solid knowledge of US FDA regulations including 21 CFR Parts 820 (QSR/QMSR), 803, 806, and 807.
  • Working knowledge of EU MDR 2017/745, including Technical Documentation requirements and Declaration of Conformity preparation.
  • Experience with ISO 13485 quality management system requirements.
  • Direct experience with Class II or III EU MDR submissions and Technical Documentation under EU MDR 2017/745.
  • Ability to correctly interpret regulations and apply them to day-to-day business operations.
  • Strong written and verbal communication skills; ability to interact effectively with individuals in scientific, technical, and regulatory fields.
  • International device registration experience (EU, Asia-Pacific, Australia, or other markets).
  • Familiarity with ISO 14971 risk management.
  • Knowledge of 510(k), MDR, and CE Marking requirements with active role in submissions leading to commercialization.
  • Familiarity with global and regional trends in regulatory affairs.
  • Strongly prefer candidates with Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) or equivalent professional certification.
  • Ability to interact with individuals in scientific and/or technical fields
  • International device registration experience (preferably EU, Asia, Canada etc.)
  • Ability to effectively negotiate and balance the need for regulatory compliance with the needs of the business
  • Ability to correctly interpret regulations as they apply to day to day business operations.

Perks / Benefits:

  • Generous Paid Time Off
  • Paid Breaks
  • Annual Bonuses
  • 401(k) with excellent company match
  • Health Insurance with multiple plans to choose form
  • Paid Short Term and Long Term Disability

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