Staff Clinical Evaluation Specialist

About the role

Stryker is hiring a Staff Clinical Evaluation Specialist in Gurugram. The role drives the clinical evidence strategy across the new product development cycle and prepares clinical documentation to validate device safety and performance for regulatory submissions.

Key responsibilities

• Establish a coherent clinical evidence strategy aligned with marketing, regulatory and research strategies
• Prepare clinical documentation (CERs, SSCPs, PMA reports) and update it periodically to stay compliant
• Design literature search strategies, run systematic reviews and summarise published clinical data
• Conclude on the overall benefit-risk profile and flag unanswered questions and residual risks for post-market follow-up
• Review clinical evaluation documentation for compliance with internal, external quality and regulatory requirements
• Support pre-IDE, 510(k) and PMA applications and safety risk analyses, and help the Human Factors team define use scenarios
• Review complaints about adverse events or device malfunctions and contribute to corrective and preventive actions and operating instructions
• Support clinical study protocols, and review collateral materials such as clinical outcome claims

Required profile

• Bachelor's degree in a technical or scientific discipline; nursing degree or related experience in an advanced practice setting preferred
• 7 to 10 years of experience; master's or PhD in a health-related field preferred
• Strongly preferred: medical device industry experience of at least 4 years in clinical, quality or regulatory affairs
• Scientific or medical writing experience and clinical research background preferred
• Ability to travel up to 20%

Required skills

• Reading, analysing and interpreting regulations, technical standards, guidance documents, test reports and clinical terminology
• Technical product information and complex documents
• MS Office and general IT proficiency
• Ability to train and mentor juniors, own internal procedures and present to management