EU MDR Regulatory Content Specialist

1 day ago


Exton, Pennsylvania, United States DEV-X Consulting LLC Full time
Job Title: EU MDR Regulatory Content Specialist

About DEV-X Consulting LLC
DEV-X Consulting LLC is a leading provider of medical device regulatory consulting services. Our team of experts helps clients navigate the complex EU MDR landscape and ensure compliance with all relevant regulations.

Job Summary
We are seeking a highly skilled EU MDR Regulatory Content Specialist to join our team. In this role, you will be responsible for coordinating the EU MDR program work for claims with other copy review workstreams such as active CAPAs. You will also update global Surgical Technique Guides and promotional materials to all standards using compliant communication process.

Key Responsibilities
* Coordinate the defined cadence of the EU MDR program work for claims with other copy review workstreams such as active CAPAs.
* Update global Surgical Technique Guides and promotional materials to all standards using compliant communication process.
* Lead and manage routings including STG, promotional materials and claims.
* Create and approve claims collection and substantiation and approval.
* Manage all asset edits with vendor and create proof within stated budget and timeline.
* Complete and approve associated F-S813 (Design Evaluation Form) to support EOS routing.
* Manage EOS routing and complete approval process for STGs, promotional materials and claims.
* Store and redistribute final approved assets.

Requirements
* Must have Medical Device Experience within EU MDD and/or EU MDR.
* Strong knowledge of EU MDR regulations and guidelines.
* Excellent communication and project management skills.

What We Offer
* Competitive salary: $80,000 - $100,000 per year.
* Opportunities for professional growth and development.
* Collaborative and dynamic work environment.

How to Apply
If you are a motivated and detail-oriented individual with experience in EU MDR regulatory consulting, please submit your application.

  • Exton, Pennsylvania, United States DEV-X Consulting LLC Full time

    Job OverviewDEV-X Consulting LLC is seeking a highly skilled EU MDR Marketing Claims Specialist to join our team. This role requires strong knowledge of the EU Medical Device Regulation (MDR) and experience in creating compliant marketing claims.


  • Exton, Pennsylvania, United States DEV-X Consulting LLC Full time

    Company Overview: DEV-X Consulting LLC is a leading consulting firm that specializes in providing expert services to companies operating in highly regulated industries. Our team has extensive experience in managing complex projects and ensuring compliance with regulatory requirements.Job Description: As a Regulatory Affairs Project Coordinator, you will play...


  • Exton, Pennsylvania, United States DEV-X Consulting LLC Full time

    About the RoleWe are looking for a highly organized and detail-oriented Marketing Claims Coordinator to coordinate the defined cadence of the EU MDR program work with other copy review workstreams such as active CAPAs. The ideal candidate will have experience in medical devices within the EU MDD and/or EU MDR regulations.


  • Exton, Pennsylvania, United States DEV-X Consulting LLC Full time

    Project Manager Role at DEV-X Consulting LLCWe are searching for a highly motivated and experienced project manager to join our team at DEV-X Consulting LLC. As a key member of our team, you will play a critical role in driving project success.The salary for this role is estimated to be around $90,000 - $120,000 per year, depending on experience and...


  • Exton, Pennsylvania, United States Joulé Full time

    Job Title: Environmental Monitoring SpecialistLocation: Exton, PAType: 6-month Contract to Hire Schedule: Monday - Friday 8A-5POverview:We are seeking a skilled Environmental Monitoring Specialist to join our team at Joulé. As a key member of our team, you will be responsible for monitoring and maintaining the quality of environmental systems in our cell...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job OverviewWe are seeking a Senior Pharmaceutical Quality Assurance Director to join our team at Frontage Laboratories, an award-winning Contract Research Organization (CRO). This is a critical role in ensuring the development, maintenance, and continuous improvement of quality management systems.About UsFrontage Laboratories operates over 25...


  • Exton, Pennsylvania, United States Groundwater and Environmental Svcs. Full time

    We are seeking an experienced Field Services Specialist to join our team at Groundwater & Environmental Svcs. in Exton, Pennsylvania. In this role, you will execute, supervise, and document various environmental services including site assessment, remediation, and construction activities.Responsibilities:Site Assessment: Conduct site assessments to identify...


  • Exton, Pennsylvania, United States Clinical Resource Network (CRN) Full time

    Job OpportunityClinical Resource Network (CRN), a division of Solomon Page, is seeking an experienced Quality Control Lab Manager to join our team.About the RoleThe successful candidate will be responsible for staff management of quality control analysts and environmental monitoring specialists, ensuring day-to-day scheduling of activities is appropriately...


  • Exton, Pennsylvania, United States Groundwater and Environmental Svcs. Full time

    Job DescriptionGroundwater & Environmental Services, Inc. (GES) is a leading provider of environmental consulting and engineering services, seeking a Mid-Level Air Quality Engineer/Scientist to join our team. As a key member of our air quality services group, you will be responsible for executing technical work, including source reviews, regulation...


  • Exton, Pennsylvania, United States KOMAN Government Solutions, LLC Full time

    We are seeking a skilled Sustainable Environmental Specialist to support our operations in Exton, PA. The ideal candidate will have experience with project planning and permitting, site investigation, environmental monitoring and sampling, remedial action implementation, and operation & maintenance (O&M) of landfill facilities.What We Offer:$110,000 -...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Company Overview:Frontage Laboratories Inc. is a reputable organization committed to excellence in its field.Salary:$60,000 - $80,000 per year, depending on experience.Job Description:We are seeking an organized and detail-oriented individual to fill the role of Executive Support Coordinator. This position will involve providing administrative support to our...


  • Exton, Pennsylvania, United States Pharmaron Full time

    Job Overview:We are seeking a highly skilled Software Validation Engineer to join our team at Pharmaron in Exton, PA. As a critical member of our Quality Assurance department, you will be responsible for ensuring all GLP/GMP computer systems remain compliant and validated software meets regulatory requirements.You will oversee the entire validation...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job OpportunityWe are seeking a highly skilled Scientific Researcher to join our team at Frontage Laboratories in Exton, PA.About the RoleThis full-time position involves performing routine and non-routine microbiology sample analysis, including MLT/Bioburden, Endotoxin, Environmental Monitoring, Sterility, and AET. The successful candidate will work closely...


  • Exton, United States West Pharmaceutical Services Full time

    Job Summary : This Senior Specialist, Regulatory Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West’s global portfolio of medical devices, combination products, SaMDs, and packaging components. The RPM will work collaboratively with cross functional teams and lead the regulatory team through...


  • Exton, United States Frontage Lab Full time

    CSV and Lab Application Support Specialist Title: CSV and Lab Application Specialist Location: Exton, PA Reports to: Senior Director IT Infrastructure Full-time (40 hrs./week) on site Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and...


  • Exton, United States Frontage Laboratories Full time

    CSV and Lab Application Support SpecialistTitle: CSV and Lab Application SpecialistLocation: Exton, PAReports to: Senior Director IT Infrastructure Full-time (40 hrs./week) on siteFrontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China....


  • Exton, United States Frontage Laboratories Full time

    CSV and Lab Application Support SpecialistTitle: CSV and Lab Application SpecialistLocation: Exton, PAReports to: Senior Director IT Infrastructure Full-time (40 hrs./week) on siteFrontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China....

  • LIMS Lab IT

    5 days ago


    Exton, United States Planet Technology Full time

    LIMS Lab IT & CSV Specialist (Perm) – Onsite – PA Award-winning CRO seeks a LIMS Lab IT & CSV Specialist for an onsite perm role. Ideal candidate will have 2+ years’ experience within main analytical lab instrumentation, computer systems validation and systems administration to include LIMS, ELN, LMS, CDS (systems similar to LIMS, Empower, and...


  • Exton, United States Staff Full time

    The Litigation Client Service Specialist role is responsible for providing legal administrative support to a team of attorneys by performing complex, administrative assistance using specialized knowledge of the assigned practice area(s). This position works collaboratively and cooperatively with others in a team-oriented environment to deliver the highest...


  • Exton, United States Staff Full time

    The Litigation Client Service Specialist role is responsible for providing legal administrative support to a team of attorneys by performing complex, administrative assistance using specialized knowledge of the assigned practice area(s). This position works collaboratively and cooperatively with others in a team-oriented environment to deliver the highest...


  • Exton, United States BELFOR Property Restoration Full time

    Job DescriptionJob DescriptionThis position is responsible for providing operational support in mitigation efforts for clients. Qualified candidates must have the ability to perform tasks related to pumping and extracting water, as well as mold removal, and must use various types of specialized equipment under supervision. This position represents level 2 in...