Cyient is a global leader in engineering, manufacturing, and digital solutions, serving industries like medical devices, aerospace, and healthcare. With a strong focus on compliance and innovation, Cyient helps medical device companies meet EU MDR 2017/745, US FDA, and other regulatory standards.
Job Description: Medical Device Post-Market Surveillance (PMS) Specialist
Key Responsibilities:
✔ Post-Market Surveillance (PMS) Activities
- Conduct PMS reviews, trend analysis, and risk assessments as per EU MDR 2017/745 & US FDA guidelines.
- Prepare Periodic Safety Update Reports (PSURs), Post-Market Clinical Follow-up (PMCF) reports, and Vigilance reports.
- Monitor adverse events, complaints, and field safety corrective actions (FSCA).
✔ Regulatory Compliance & Documentation
- Ensure compliance with ISO 13485, EU MDR, FDA 21 CFR Part 803/820.
- Support audits (Notified Body, FDA, internal) and maintain PMS documentation.
- Collaborate with QA/RA teams for PMS-related submissions.
✔ Data Analysis & Reporting
- Analyze post-market data to identify safety signals & trends.
- Generate PMS plans, risk-benefit assessments, and CAPA recommendations.
Eligibility Criteria (Must Have)
✅ Minimum 3+ years in Medical Device PMS (Candidates with <3 years will not be considered).
✅ Hands-on experience with EU MDR 2017/745, US FDA PMS requirements.
✅ Strong knowledge of ISO 13485, risk management (ISO 14971), and PMS reporting tools.
✅ Ability to join within 3-4 weeks (Immediate joiners preferred).
Preferred Qualifications:
- Experience in PMS for Class II/III medical devices.
- Familiarity with MEDDEV 2.12-1, MDCG guidelines.
- Strong technical writing & data analysis skills.
How to Apply?
Email your resume to: abhishek.kumar2@cyient.com
Subject Line: “Application for Medical Device PMS Specialist – [Your Name]”
