Staff Clinical Evaluation Specialist

Stryker Corporation; Gurugram District; On-site; INR 1,000,000 - 2,000,000; Full time

Job summary

Stryker Corporation is seeking a senior Clinical Affairs professional to lead the clinical evidence strategy across new product development cycles. The role involves preparing regulatory submissions, performing literature reviews, and supporting safety risk analysis.

You will collaborate with marketing, regulatory, and research teams to ensure robust, compliant clinical inputs for product launches and post-market activities.

Qualifications

• Experience in medical writing and regulatory affairs in a medical device context.
• Experience in clinical, quality or regulatory affairs in the medical device industry preferred.
• Bachelor's degree in technical/scientific field; nursing or related advanced degree desired.

Responsibilities

• Develop and align the clinical evidence strategy across the product development lifecycle.
• Prepare regulatory documents (CERs, SSCPs, PMA) and maintain compliance.
• Review and summarize published clinical data via literature searches and systematic reviews.

Skills

Medical writing

Regulatory affairs

Clinical research

Project coordination

Education

Bachelor's degree in technical or scientific discipline

Nursing or related field (RN/BSN/MD)

Master's/PhD in health-related field

Tools

MS Office

Job description

Work Flexibility: Not available

What you will do

Drive the establishment of a coherent Clinical evidence strategy plan throughout the new product development cycle, and ensure alignment with adjacent complex processes (Marketing strategy and claim, regulatory strategy, research strategy) Prepare clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g CERs, SSCPs, PMA reports). Design compliant and sutainable literature search strategies, perform systematic reviews to capture and summarize published clinical data Formulate conclusion on the overall benefit-risk profile of the subject device, in collaboartion with appropriate stakeholders Identifies unanswered questions and residual risks in the Clinical Evidence and provides input to Post Market Clinical Follow Up activities in collaboration with Clinical Research team to address these questions Reviews clinical evaluation documentation authored by peers, junior, or external contributors for compliance internal and external quality and regulatory requirements Provide clinical input to project plans, pre-IDE and 510(k) and PMA applications by describing user needs, user characteristics, intended use and clinical application of products; advocate the safety of devices for the operator and the patient Particiapte in the development of the safety risk analysis Support the Human Factors team to develop use scenarions and user needs when needed Review product related complaints related to potential adverse events or device malfunctions to determine whether or not the device use contributed to harm Provide input to and participate in post-production Corrective and Preventive Action activities and provide input in the creation of operating instructions (manuals, labeling, quick reference labeling, operator installation/getting started instructions, in-service video and other user instructional or clinically-oriented literature) and evaluate accuracy and adequacy). Provide input to clinical research team on study protocol development and support the conduct of clinical studies as needed and support to marketing and engineering for customer issues Review collateral materials that includes clinical outcome claims and perform other related duties as assigned to support business needs

What you will need

Required Skills- A minimum of bachelor's degree in a technical and/or scientific discipline required Experience- 7 years- 10 years A degree in Nursing or related field or related experience in an advanced practice environment such as critical care, critical care transport, emergency room, flight nurse, or military medical training required; Master's or Ph.D or other higher degree in health related field (RN,BSN,MD) preferred Experience in medical device industry is strongly preferred; with Minimum of 4 years industry experience in clinical, quality or regulatory affairs Experience in scientific or medical writing, relevant academic or clinical research experience is preferred Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, Preferred Skills- technical product information, and complex documents and successful track record in managing complex projects Ability to train and mentor junior team members; to own and maintain internal procedures and processes and to effectively present information to other employees and management Good MS Office skills and general IT proficiency Ability to travel up to 20% Travel Percentage: None

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.