Remote MedTech Regulatory: Clinical Evaluation & Docs

MDx CRO; Portugal; Hybrid; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Flexible remote work

International exposure

Professional development

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

Clinical evaluation

Technical documentation

CER preparation

Scientific writing

EU MDR knowledge

English fluency

Remote work availability

Education

Bachelor's degree in Health Sciences

Job description

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.