Wipro is inviting applications from experienced healthcare and life sciences professionals for the position of Medical Device Investigator (B1 Band). This opportunity is ideal for candidates with 3–5 years of experience in medical device complaint management, pharmacovigilance, clinical evaluation, or healthcare quality systems who want to build a long-term career in regulatory safety and device surveillance.
This role offers exposure to global medical device regulations, post-market surveillance, risk assessment, and patient safety processes—making it a strong career move for professionals transitioning into medical device vigilance and regulatory science domains.
📍 Job Location
- Kolkata, India
- Pune, India
💼 Role Overview – Medical Device Investigator
The Medical Device Investigator will be responsible for evaluating product complaints, performing root cause analysis, and ensuring compliance with global regulatory requirements such as FDA MDR, EU MDR, ISO 13485, and post-market surveillance frameworks.
🔎 Key Responsibilities
- Review and investigate medical device complaints and adverse event reports.
- Perform root cause analysis (RCA) and determine reportability as per global regulations.
- Evaluate device performance, malfunction trends, and potential safety risks.
- Prepare investigation reports aligned with regulatory and quality management system (QMS) requirements.
- Collaborate with cross-functional teams including QA/RA, engineering, and clinical safety.
- Ensure compliance with post-market surveillance (PMS) and vigilance guidelines.
- Support CAPA activities, risk management documentation, and audit readiness.
- Maintain accurate documentation aligned with ISO 13485, FDA, and EU MDR standards.
🎓 Eligibility Criteria (Mandatory Qualifications)
Candidates must possess one of the following qualifications:
- B.Pharm / M.Pharm
- Biomedical Engineering / Mechanical Engineering
- BSc Medical Imaging & Radiology Technology
- Master’s in Molecular Biology
- BSc Nursing / BDS / BSc Biology / BS Medical
- Bachelor of Physiotherapy
- BS Occupational Therapy / Psychology / Optometry
- BS Respiratory Therapy / Midwifery
- BS Speech Language Pathology
- BS Veterinary Medicine
🧠 Required Experience
- 3–5 years in:
- Medical Device Complaint Handling
- Pharmacovigilance / Materiovigilance
- Clinical Safety or Risk Management
- Healthcare Quality or Regulatory Operations
💰 Expected Salary Range
Based on industry benchmarks for B1 Band roles in India:
- ₹6.5 LPA – ₹10 LPA (depending on experience, domain expertise, and technical skills)
🌟 Why This Role is Important for Your Career
This role positions professionals in the rapidly growing medical device vigilance and regulatory compliance sector, which is expanding globally due to stricter safety regulations and increasing device innovation.
You will gain experience in:
- Global Medical Device Regulations (FDA, EU MDR)
- Post-Market Surveillance (PMS)
- Risk Management & CAPA
- Clinical Evaluation Support
- Healthcare Compliance Analytics
📩 How to Apply
Interested and eligible candidates can send their updated CV for referral to:
Email: Shad.akhtar@wipro.com