Shikha Jindal
Regulatory Affairs Specialist @Tata Elxsi
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WORK HISTORY
Regulatory Affairs Specialist @Tata Elxsi
Pune, IN
Specialised focus on authoring and reviewing regulatory documents oftherapeutical medical implants under EU MDR compliance. The core area ofexpertise in Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER)and Summary of Safety and Clinical Performance (SSCP)- Contributed to the curation and implementation of projects assigned withinternational clients based out of the European Union [Switzerland, France andGermany]- Performed advanced analysis from clinical trials and shared observationalstudies to unravel the underlying mechanism of diseases- Gained hands-on expertise with Literature search databases [Embase,PubMed, Medline, Google Scholar] and Journal Citation tools [Endnote andMendeley]- Collaborative experience working in high-performance teamswith aggressive timelines and process orientation.
EDUCATION
Indian Institute of Technology, Bombay
Doctor of Philosophy - PhD, Biotechnology
UIET Panjab University
Bachelor's degree, Biotechnology
ABOUT SHIKHA JINDAL
Specialist Medical Writer | Regulatory & Scientific Communications | EU MDR | Oncology & Metabolic Diseases | CERs | MedCommsI’m a PhD-trained medical writer with 6+ years of experience delivering high-quality regulatory writing and medical communications across therapeutic areas, including oncology, diabetes, and rare diseases, and scientific content to clients across the US, UK, and APAC. I specialize in developing compliant, audit-ready documents for global medtech and pharmaceutical teams, including:Clinical Evaluation Reports (CERs) under EU MDR 2017/745CEPs, PSURs, SSCPs, and benefit–risk assessmentsSystematic Literature Reviews (PRISMA, GSPR-aligned)Scientific slide decks, manuscripts, and infographicsI’ve worked across oncology, diabetes, and rare disease portfolios, supporting CE-marking and MAA documentation for medtech, pharma, and biotech teams. Proven ability to work independently and meet tight deadlines Strong research, writing, and QC skills with a regulatory mindset Comfortable collaborating with global teams across time zonesAvailable for remote/freelance opportunities in regulatory and medical communications.
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