Clinical Research Job at Zydus Medtech Private Limited
Looking for a Clinical Research Job in the growing medical device industry? Zydus Careers has an opening for a Clinical Evaluation Manager in Ahmedabad for professionals with 2–5 years of relevant experience. Candidates from Life Sciences, Medicine, Pharmacy, Nursing and Biomedical Engineering backgrounds can apply. Among specialized Medical Jobs India, this opportunity focuses on clinical evaluation, medical writing, regulatory compliance, CERs and medical-device safety and performance.
About Zydus Medtech Private Limited:
Zydus Medtech Private Limited operates in the medical technology sector, focusing on the development and manufacturing of medical devices and healthcare solutions. The organization emphasizes product quality, patient safety and regulatory compliance throughout the medical-device lifecycle. Professionals exploring Zydus Careers can consider opportunities spanning clinical, regulatory and scientific functions. This Clinical Research Job provides experienced life science professionals exploring Medical Jobs India with an opportunity to contribute to clinical evaluation and MedTech development.
Job Details:
- Job ID: JOB11018
- Division: MedTech Office
- Location: Zydus Medtech Private Limited|ZMPL Office, Ahmedabad, Gujarat, India
- Employee Type: P-P8-Probationer-HO Executive
Job Description:
This Clinical Research Job at Zydus Medtech is for a Clinical Evaluation Manager responsible for collecting, analyzing and documenting clinical evidence supporting medical-device safety and performance. The role covers Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMCF documentation, SSCPs, literature reviews and regulatory compliance. The selected candidate will also collaborate with Regulatory Affairs, R&D, Quality Engineering and Marketing teams throughout the product lifecycle.
Key Responsibilities:
- Develop and maintain Clinical Evaluation Plans (CEPs).
- Prepare, review and update Clinical Evaluation Reports (CERs).
- Develop Post-Market Clinical Follow-up (PMCF) plans.
- Support Summary of Safety and Clinical Performance (SSCP) documentation.
- Ensure documentation complies with applicable medical-device regulations.
- Support compliance with EU MDR 2017/745 and MEDDEV 2.7/1 Rev 4.
- Respond to clinical questions raised by notified bodies.
- Conduct systematic and evidence-based literature searches.
- Analyze clinical and risk data to assess device benefit-risk profiles.
- Guide medical writers and review clinical documentation.
- Establish timelines and ensure timely project deliverables.
- Collaborate with R&D, Regulatory Affairs, Quality Engineering and Marketing.
- Support new product development activities.
- Contribute clinical evidence to risk-assessment activities.
Eligibility Criteria for this Clinical Research Job:
-
Candidates interested in this Clinical Research Job should possess:
- Bachelor’s or Master’s degree in Life Sciences
- Relevant backgrounds may include:
- Nursing
- Medicine
- 2–5+ years of experience in medical writing, clinical research or Regulatory Affairs within the medical-device industry
- Knowledge of EU MDR 2017/745
- Knowledge of MEDDEV 2.7/1
- Understanding of ISO 14971 and ISO 14155
Skills Required for this Clinical Research Job:
- Clinical Evaluation & Clinical Research
- CER, CEP, PMCF & SSCP Documentation
- Medical & Regulatory Writing
- EU MDR & MEDDEV Compliance
- Scientific Literature Review & Evidence Analysis
- Clinical Data & Benefit-Risk Assessment
- Medical Device Risk Management
- Project Management & Cross-Functional Collaboration
