4C Pharma Solutions is a global leader in healthcare solutions, specializing in pharmacovigilance, medical device vigilance, regulatory affairs, and medical writing. Committed to patient safety and compliance, we provide end-to-end support for pharmaceutical and medical device companies.
Job Description: Medical Device Vigilance Specialist
Role Overview
We are seeking a fluent Polish speaker with 2-3 years of experience in medical device vigilance, post-market surveillance, and adverse event reporting. You will ensure compliance with EU MDR, FDA 21 CFR 803, ISO 13485, and ISO 14971 while managing safety reports and collaborating with cross-functional teams.
Key Responsibilities
✔ Monitor & Report Adverse Events – Assess complaints and adverse events for reportability under FDA/EU MDR.
✔ Prepare Regulatory Submissions – Draft MDRs, Field Safety Notices (FSNs), and vigilance reports.
✔ Maintain Vigilance Databases – Ensure accurate documentation in systems like MAUDE, EUDAMED.
✔ Post-Market Surveillance (PMS) – Develop PSURs, trend analyses, and risk assessments.
✔ Cross-Functional Collaboration – Work with Quality, Regulatory, R&D, and Clinical teams for root cause analysis.
✔ Audit & Compliance Support – Assist in internal/external audits and interactions with Competent Authorities.
Eligibility Criteria
✅ Language: Fluent in Polish (written & spoken) + strong English proficiency.
✅ Experience: 2-3 years in medical device vigilance, complaint handling, or post-market surveillance.
✅ Education: Bachelor’s in Life Sciences, Biomedical Engineering, or related field.
✅ Regulatory Knowledge: EU MDR 2017/745, FDA 21 CFR 803, ISO 13485, ISO 14971.
✅ Technical Skills: Experience with Power BI, Tableau, Excel, or vigilance databases.
✅ Soft Skills: Strong analytical mindset, attention to detail, teamwork, and communication.
Why Join 4C Pharma Solutions?
✨ Global Exposure – Work with international regulatory frameworks.
📈 Career Growth – Training & professional development opportunities.
💰 Competitive Salary & Benefits – Health insurance, flexible work options.
⚖ Work-Life Balance – Supportive and agile work environment.
How to Apply
- Email your CV + Cover Letter to rohina.p@4cpharma.com (mention Polish fluency & experience).
