Shrutee Jadhav
Clinical Operations | Clinical Evaluation | EU MDR | Medical Writing | Qc Specialist | Lean Six sigma Green belt
- Role
- Clinical Evaluation Specialist at Stryker
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Shrutee Jadhav
Possess over 6 years of experience in Clinical Operations within the healthcare industry, currently excelling as a Clinical Evaluation Specialist at Stryker, Gurugram.Skilled in managing regulatory submissions, leading clinical trials, and monitoring site activities effectively.Proficient in adhering to MEDDEV guidelines and ensuring compliance with EU Medical Device Regulations.Proactively improved document management processes and regulatory compliance through innovative solutions, resulting in streamlined operations and enhanced team efficiency.Expertise in comprehensive clinical evaluations compliant with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR), aligned with MDCG guidelines.Led initiatives to enhance document clarity and compliance, driving improvements in training programs and data analysis efficiency to support regulatory submissions effectively.Successfully achieved a notable milestone, impacting the organization\'s progress.Hold extensive expertise in conducting clinical evaluations and managing post-market clinical follow-up processes for medical devices.Successfully implemented automated notifications system, improving document management efficiency.Led the recreation of the Medical Affairs tracker, enhancing the efficiency of information collation processes.Stayed up-to-date of industry trends, regulatory updates, and advancements in clinical research methodologies, incorporating new knowledge into daily practices to optimize trial outcomes.
Experience
Clinical Evaluation Specialist
Apr 2024 — Present
Education
Mumbai University
Bachelor of Pharmacy
2015 — 2019
Clini India
Post Graduation Diploma
2021 — 2021
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