Technical Specialist MedTech | Clinical Evaluation & Technical Documentation

MDx CRO; Portugal; Híbrido; EUR 60.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible remote work

International exposure

Professional development

Descripción de la vacante

MDx CRO is seeking an experienced Regulatory Affairs professional with focus on clinical evaluation, medical writing and technical documentation for medical devices to join our consulting team in Portugal. You will prepare and assess CEPs, CERs, and EU MDR documentation, collaborating with regulatory consultants on international projects.

The role offers autonomy within a supportive team, remote work with occasional travel, and exposure to leading MedTech clients across Europe.

Formación

• 3–5 years of experience in medical device regulatory affairs, clinical evaluation or technical documentation.
• Bachelor's degree in Health Sciences, Biomedical Engineering, Biology, Pharmacy or related field.
• Proven hands-on experience preparing CER under the EU MDR.
• Excellent scientific and technical writing skills.

Responsabilidades

• Prepare CEPs and CERs, including literature reviews and critical appraisal of clinical evidence.
• Contribute to clinical evaluation strategies and scientific justifications with regulatory consultants.
• Prepare, review and assess EU MDR technical documentation, including V&V, PMS and PMCF.
• Identify evidence gaps and contribute to their resolution.
• Assist in regulatory documentation for the US market (FDA 510(k)) and IRB materials.
• Support QMS documentation and procedures when required.
• Collaborate with multidisciplinary teams to ensure alignment across deliverables.
• Share knowledge and help improve internal processes.

Conocimientos

Regulatory affairs

Clinical evaluation

Technical documentation

CER preparation

Scientific writing

EU MDR knowledge

English fluency

Remote work availability

Educación

Bachelor's degree in Health Sciences

Descripción del empleo

Location: Portugal (Remote with occasional in‑person activities)

Role Summary

We are looking for an experienced and technically skilled Regulatory Affairs professional with a strong focus on clinical evaluation, medical writing and technical documentation for medical devices to join our growing consulting team.

As a Technical Expert – Clinical Evaluation & Technical Documentation, you will contribute to the preparation, review and assessment of clinical, technical and regulatory documentation, helping medical device manufacturers demonstrate compliance with applicable regulatory requirements.

You will contribute to a variety of international client projects, working closely with regulatory consultants and other specialists within multidisciplinary teams.

This role is ideal for professionals with3–5 years of experiencewho enjoy scientific and technical work, critical analysis and solving complex regulatory challenges within a collaborative consulting environment.

Responsibilities

You will:

• PrepareClinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs), including literature reviews, state‑of‑the‑art assessments and critical appraisal of clinical evidence.
• Contribute to the development of clinical evaluation strategies and scientific justifications in collaboration with regulatory consultants and other technical specialists.
• Prepare, review and assessmedical device technical documentationunder the EU MDR, including risk management, verification and validation (V&V), post‑market surveillance (PMS) and PMCF documentation.
• Perform clinical and technical documentation gap assessments, identify evidence gaps and contribute to their resolution.
• Contribute to the preparation of regulatory documentation for the US market, includingFDA 510(k) submissions, and documentation for Institutional Review Board (IRB) review.
• Support the preparation and review of Quality Management System (QMS) documentation and procedures, when required.
• Collaborate with multidisciplinary teams to ensure consistency and alignment across clinical, technical and regulatory deliverables.
• Share technical knowledge and contribute to the continuous improvement of internal processes, templates and methodologies.

You will enjoy a high degree of autonomy in your technical work while receiving support from a collaborative team of experienced regulatory and clinical specialists.

Requirements (Must‑Have)

• 3–5 years of experiencein medical device regulatory affairs, clinical evaluation or technical documentation.
• Bachelor's degree (or higher) in Health Sciences, Biomedical Engineering, Biology, Pharmacy or a related discipline.
• Proven hands‑on experience preparing Clinical Evaluation Reports (CERs)under the EU MDR.
• Excellentscientific and technical writing skills, including the ability to critically assess, interpret and synthesise scientific evidence.
• Strong knowledge of EU MDR requirements and medical device technical documentation.
• Experience preparing, reviewing or assessing technical and regulatory documentation for medical devices.
• Strong analytical, organisational and problem‑solving skills, with attention to detail.
• Ability to work autonomously on technical assignments while collaborating effectively within multidisciplinary teams.
• Ability to manage multiple assignments and priorities.
• Fluent English (written and spoken).
• Availability for remote work with occasional travel, when required.

Nice to Have

• Experience in a consulting or CRO environment.
• Experience in biological evaluation under ISO 10993, including preparation of Biological Evaluation Reports (BERs) or Biological Safety Assessment Reports (BSARs).
• Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366 or other applicable medical device standards.
• Experience preparing documentation for FDA regulatory submissions.
• Experience working with Software as a Medical Device (SaMD) or AI‑based medical devices.
• Spanish and/or Portuguese.
• Experience preparing or reviewing QMS documentation and procedures.

What Makes You a Great Fit

You are someone who enjoys tackling complex scientific and technical challenges and translating evidence into clear, accurate and well‑structured documentation.

You work autonomously, take ownership of your deliverables and are comfortable contributing to several projects simultaneously. You have a critical mindset, strong attention to detail and a commitment to delivering high‑quality technical work.

You enjoy collaborating with specialists from different disciplines, sharing knowledge and contributing to technical discussions to achieve the best possible outcomes.

Most importantly, you combine technical expertise with a collaborative mindset and a genuine interest in helping innovative medical technologies reach patients safely and efficiently.

Why Join MDx CRO

At MDx CRO, you will join a dynamic and rapidly growing company recognised across the MedTech and IVD industry. We offer:

• High‑impact consulting projects with leading MedTech innovators
• Significant autonomy and ownership from day one
• Exposure to international regulatory and quality challenges
• Continuous professional development and training
• Collaboration with experienced specialists across Regulatory Affairs, Clinical Research, Medical Writing, and Quality Assurance
• Career progression opportunities within a fast‑growing international company
• Flexible remote working environment

About MDx CRO

MDx CRO is a leading Contract Research Organisation specialising in medical devices and in vitro diagnostics (IVDs). We provide regulatory consulting, clinical research, medical writing, and quality assurance services, helping manufacturers bring innovative healthcare technologies to market while ensuring full compliance with global regulatory requirements.

We operate on five core principles:

• Make it POSSIBLE
• Make it WIN‑WIN
• Keep IMPROVING
• Keep GROWING
• Keep it DIVERSE

Our Vision

To democratise access to world‑class regulatory and clinical strategies, ensuring safer and more effective medical technologies for all.

Our Mission

We pioneer emerging technologies and navigate uncharted territories to redefine the future of the medical sector.

Grow with Us

If you are looking to take the next step in your Regulatory Affairs and Quality Assurance career, enjoy working with innovative medical technologies, and want to make a meaningful impact through consulting, we'd love to hear from you.