JOIN MDx TEAM: WHERE INNOVATION MEETS EXCELLENCE
Are you a passionate professional in the field of medical devices and in-vitro diagnostics (IVD)? Are you dedicated to clinical research, regulatory affairs, or ensuring the highest quality standards? If so, MDx invites you to be part of its dynamic team. Ready to take your career to the next level?
Explore exciting career opportunities with us in clinical research, regulatory affairs, and quality management. Be a part of the future of healthcare.
Why Choose MDx CRO?
MDx CRO is a leading contract research organization specializing in medical devices and IVDs. MDx´s commitment is to advancing healthcare through cutting-edge research and regulatory compliance has made us a trusted partner for industry leaders worldwide.
- Innovation: We’re at the forefront of medical technology, pushing boundaries and driving innovation in the field.
- Excellence: Our dedication to quality and regulatory compliance ensures that every project meets the highest industry standards.
- Collaboration: Join a diverse team of experts who collaborate seamlessly to achieve common goals.
How to Apply?
Interested candidates are invited to apply by submitting their resume and cover letter to contact@mdtcro.com. Join us in making a meaningful impact on healthcare through clinical research, regulatory and quality.
CLINICAL RESEARCH ASSOCIATE
Are you a dedicated clinical research professional with a deep understanding of both medical devices and in-vitro diagnostics (IVD)? MDx CRO invites you to join our team in a pivotal role as a Clinical Research Professional. In this position, you will contribute your expertise to drive forward our mission of advancing healthcare through cutting-edge research and innovation. We are dedicated to pushing the boundaries of medical technology and invite you to be part of our transformative journey.
As a Clinical Research Professional, you will be at the forefront of our research initiatives. Collaborating closely with our team of experts, including clinicians, regulatory specialists, and project managers, you will play a vital role in the planning, execution, and management of clinical trials for medical devices and IVDs.
Responsibilities
- Develop clinical protocols, case report forms, and informed consent forms in accordance with GCP standards, Helsinki Declaration, ISO 14155, ISO 20916, MDR, and IVDR.
- Conduct site feasibility assessments and site initiation, including Regulatory and Ethics Committee submissions, and provide training to site personnel on protocols and CRFs.
- Ensure the adequacy of regulatory documents and compliance with EC requirements.
- Oversee site management and monitoring activities.
- Maintain site and internal documentation following SOPs.
- Serve as the key contact for assigned clinical sites throughout the study.
- Perform medical writing tasks and provide scientific expertise in line with good publication practices and guidance.
- Engage in international communication with manufacturers.
- Contribute to project management activities.
Qualifications
- 1-3 years of professional experience as a Clinical Research Associate (CRA) with expertise in medical products and medical devices.
- A working knowledge of Good Clinical Practice (GCP) standards.
- Advanced verbal and written English skills, reaching C1-C2 proficiency.
- Preferred experience in academic research (1 to 3 years), with a track record of peer-reviewed literature as a scientist.
- A bachelor’s degree in life sciences.
- A master’s program in life sciences.
- A Ph.D. in a medical discipline, which is highly preferred.
- A desire to thrive in a fast-paced growth-stage environment.
- Flexibility for remote work and in-person activities.
CLINICAL PROJECT MANAGER
Are you an experienced Clinical Project Manager looking to make a meaningful impact in the field of medical devices and in vitro diagnostics? MDx CRO invites you to join our team as a Clinical Project Manager. In this full-time position, you will play a pivotal role in the development of clinical operations and coordination of clinical studies, ensuring compliance with GCP and European and local regulations and guidelines. Our commitment to advancing healthcare through innovation has made us a trusted partner for industry leaders worldwide. Join us in our mission to drive progress in the medical technology sector.
As a Clinical Project Manager, you will be at the forefront of our clinical research efforts. Your responsibilities will span from initiating and managing clinical projects to monitoring their progress against project plans and performance indicators for quality and budget. You will identify risks, develop mitigation plans, and serve as the key point of contact for project stakeholders.
Responsibilities
- Initiate and manage clinical projects in strict accordance with relevant guidelines, legislation, and SOPs.
- Monitor the progress of clinical trials, ensuring adherence to project plans and quality benchmarks.
- Identify risks, develop and implement mitigation plans in collaboration with team members and stakeholders.
- Act as the primary point of contact for the sponsor and project team members.
- Develop research-specific documents, trial master files (TMF), and electronic trial master files (eTMF).
- Report progress to the internal project team and stakeholders.
- Negotiate contracts with research centers and suppliers.
- Manage project finances in accordance with the sponsor contract and budget.
- Provide input for proposals and budgets, including participation in bid defense meetings.
- Engage in project management activities to ensure the successful execution of clinical projects.
Qualifications
- 1-3 years of professional experience as a Clinical Project Manager (CPM) with expertise in medical products, medical devices, or IVDs.
- A solid understanding of Good Clinical Practice (GCP).
- Advanced verbal and written English skills (C1-C2 level).
- Preferred experience in academic research (1 to 3 years), with a track record of peer-reviewed literature as a scientist.
- A bachelor’s degree in life sciences.
- A master’s program in life sciences.
- A Ph.D. in a medical discipline, which is highly preferred.
- A desire to thrive in a fast-paced growth-stage environment.
- Flexibility for remote work and in-person activities.
IVD QUALITY AND REGULATORY CONSULTANT
The Quality and Regulatory Consultant – IVD will collaborate closely with small, medium and large size IVD manufacturers, distributors, research institutions, and other stakeholders, to develop comprehensive technical documentation for in-vitro diagnostic medical technologies and support quality and regulatory processes.
Key areas of focus include the development of clinical evidence documentation and supporting IVD clinical performance studies. Previous hands-on experience in these areas is desirable. In this role you will have the opportunity to grow you project management skills, and be part of a disruptive IVD consultancy and CRO company that is experiencing significant growth.
You will be working with cutting edge technologies, consulting with some of the world’s most disruptive and global diagnostic manufacturers, being at the forefront of product development, clinical study design and regulatory compliance.
We are looking for an individual who is keen on taking their career to the next level and who wants to apply their IVD knowledge in a consulting role.
Responsibilities
- Develop technical documentation compliant with the European In Vitro Diagnostic Regulation (IVDR) 2017/746.
- Lead international projects in the IVD space
- Engage in scientific and technical writing pertinent to IVD.
- Provide expert scientific knowledge and adherence to Good Laboratory Practice, Good Clinical Practice and guidelines.
- Development of medical writing in clinical Performance Studies.
- Communicate effectively with international manufacturers.
- Conduct project management activities.
Qualifications
- 1-3 years of professional experience as a R&D in a IVD manufacturer or in a Clinical Laboratory.
- 1-3 years of professional experience as a regulatory or quality specialist in the IVD industry.
- Familiarity with Quality Management Systems (ISO 13485, ISO 15189, ISO 9001).
- Experience with CE Marking process under the IVDR
- Advanced proficiency in English (C1-C2 level), written and verbal
- Previous experience in Academic Research (2-5 years) is preferred.
- Contributions to peer-reviewed scientific literature as an author are desired.
- Bachelor’s degree in life sciences. A master’s degree in a relevant field would be advantageous.
- A Ph.D. in a medical discipline is preferred.
- Motivated to work in a fast-paced, growth-stage startup.
- Availability for remote and in-person activities.
MD QUALITY AND REGULATORY CONSULTANT
As an Medical Device Quality and Regulatory Consultant, you will be at the forefront of revolutionizing healthcare, collaborating with an interdisciplinary team of experts including physicians, biotechnologists, pharmacists, and engineers.
You will actively participate in the development of pioneering medical solutions, taking the lead in crafting the intricate technical documentation essential for regulatory approvals and market introductions.
In the job position of Medical Device Quality and Regulatory Consultant at MDx, you will contribute to the development of groundbreaking medical technologies, crafting the essential technical documentation required for regulatory approval and market entry. This multifaceted process encompasses clinical evaluation, preclinical testing, validation, verification, clinical studies, and project management.
Responsibilities
- Create meticulous technical documentation in unwavering adherence to European medical device regulation (MDR 2017/745).
- Excel in the art of medical writing and MedTech technical and regulatory composition, ensuring utmost clarity and compliance.
- Harness your scientific acumen to champion best publication practices and guidance.
- Facilitate seamless international communication with manufacturers, streamlining the complexity of regulatory pathways.
- Spearhead and navigate project management activities, meticulously ensuring the efficient attainment of milestones.
Qualifications
- 1-3 years of professional experience as a regulatory or quality specialist in the medical device industry.
- Profound knowledge of Quality Management Systems (ISO 13485, ISO 9001).
- Expertise in CE Marking processes, ensuring compliance with international standards.
- Exceptional verbal and written English skills, reaching C1-C2 proficiency.
- Preferred experience in academic research (2 to 5 years), with a track record of peer-reviewed literature as a scientist.
- A bachelor’s degree in life sciences.
- A master’s program in life sciences.
- A Ph.D. in a medical discipline, which is highly preferred.
- A drive to thrive in a fast-paced growth-stage environment.
- Flexibility for remote work and in-person activities.
REGULATORY AND CLINICAL STRATEGIST
Are you an ambitious academic eager to transition into the dynamic world of private industry while making an impact in the healthcare sector? MDx MedTech CRO invites you to embark on a transformative journey as a Regulatory and Clinical Strategist. We are passionate about shaping the future of medical technology, and we invite you to be part of our journey.
As a Regulatory and Clinical Strategist, you will play a pivotal role in our organization’s mission. This transitional position is designed to provide talented individuals from academia with a hands-on experience in regulatory and clinical affairs within the private sector. You will work closely with our seasoned experts to gain practical insights into the development and execution of regulatory and clinical strategies.
This unique 6-12 months transitional position is tailored for talented individuals who are ready to bridge the gap between academia and the private sector, harnessing their potential to contribute to groundbreaking medical advancements.
Working Areas
- Accompanying the development of technical documentation compliant with the European medical device regulation, MDR 2017/745 and the European in-vitro regulation IVDR 2017/746.
- Medical writing.
- MedTech technical and regulatory writing.
- Clinical studies.
- Provide Scientific expertise and understanding of good publication practices and guidance.
- International communication with manufacturers.
- Project management.
Qualifications
- Experience in Academic Research (2 to 5 years)
- Excellent computer proficiency (Microsoft® Office)
- Author of peer-reviewed literature as scientist
- Bachelor’s degree in life sciences
- Master program in life sciences
- Ph.D. in medical discipline is preferred
- Advanced English (written and spoken)
BUSINESS OPERATIONS PROFESSIONAL
Are you a dynamic individual with a passion for driving business efficiency and profitability? MDx CRO welcomes you to join our team as a Business Operations Professional. In this role, you will play a vital part in the operational excellence of our organization, contributing to marketing, business intelligence, human resources, finance, and accounting activities to advance our unique value proposition in the healthcare sector.
MDx CRO is a distinguished contract research organization specializing in medical devices and in-vitro diagnosticS. We are committed to pioneering advancements in healthcare, and we invite you to be part of our journey.
As a Business Operations Professional, you will be a key contributor to our operational excellence. You will support our international and national business development strategies, elevating our unique value proposition for MDx consulting services. Your role will encompass marketing, business intelligence, human resources, finance, and accounting activities, all geared towards enhancing company efficiency and profitability
Responsibilities
- Marketing:
- Assist in the development and implementation of the company’s marketing plan.
- Undertake various marketing projects as required.
- Engage in a range of marketing and promotional activities.
- Attend meetings where required.
- Business Intelligence:
- Collect data from internal systems and external sources, prepare it for analysis, and create reports, dashboards, and data visualizations.
- Assist company executives in identifying market trends.
- Enable BI tools to support strategic and tactical decision-making processes.
- Build BI dashboards and performance scorecards displaying visualized data on business metrics.
- Human Resources:
- Assist in developing the internal culture, values, ethics, vision, and mission.
- Contribute to the development and implementation of Human Resources policies.
- Finance and Accounting:
- Assist in the development of accounting and finance activities.
Qualifications
- An interest in International Business Operations.
- A passion for the healthcare sector.
- A spirit for international consulting roles.
- Experience in project management.
- Excellent computer proficiency.
- Strong communication, organizational, and time management skills.
- Self-motivation with the ability to meet deadlines.
- Attention to detail, process orientation, a positive attitude, and multitasking capability.
- Bachelor’s degree.
- Advanced degree preferred.
- Proficiency in English (advanced/C1).
- Working proficiency in Spanish.
- Knowledge of a third language is preferred.
MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.
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