Janani Shekar
Balingen,BW
Summary
To seek and maintain a full-time position that offers professional challenges utilizing interpersonal skills, attention to detail and problem-solving skills.
Overview
5
5
years of professional experience
Work History
Scientific Affairs Coordinator
LS Medcap GmbH
07.2024 - Current
- Responsible for the execution of projects related to scientific affairs and medical writing for clients in the medical technology sector, primarily focusing on high-risk class products
- Manage project timelines for successful completion, ensuring milestones were met and deadlines were adhered to.
- Collaborate with department heads to develop strategic plans aligning with overall company objectives, fostering a unified approach toward shared goals.
- Enhance customer satisfaction by responding promptly to inquiries and addressing concerns professionally
Trainee Scientific Affairs
LS Medcap GmbH
09.2022 - 06.2024
- Assist in creating and editing various clinical and regulatory documents (for Class IIa and Class III devices specifically), such as clinical evaluation reports and device related documents, ensuring they meet regulatory standards and scientific accuracy.
- Conduction of thorough literature reviews and scientific research to support document development, staying updated on current trends and findings in relevant state of the art and clinical background
- Collaborate with cross-functional teams to manage timelines and communication, ensuring projects are completed efficiently and effectively while adhering to quality control standards
- Underwent training and practice to enhance writing skills, regulatory knowledge, and understanding of relevant medical fields, while also receiving mentorship from experienced medical writers to foster professional growth.
Project Assistant: Regulatory & Clinical Research
SpotSense Healthcare Private Limited
01.2020 - 08.2020
- Map out regulatory phases for ongoing projects
- Document preparation for submission to stakeholders and regulatory agencies
- Gap analysis and fixing of non compliances
- Handled administrative duties, filing, and errands.
Education
Master of Science - Biomedical Engineering
Hochschule Furtwangen University
Villingen-Schwenningen, Germany06-2022
Bachelor's in Engineering (B. E.) - Biomedical Engineering
Rajiv Gandhi Institute of Technology
Bangalore, India05-2019
Skills
- MS Office
- Regulatory Compliance
- Regulatory requirements
- Medical Writing
- Technical Documentation
- European Medical Device Regulation (EU MDR)
Languages
English
Bilingual or Proficient (C2)
German
Intermediate (B1)
Telugu
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Timeline
Scientific Affairs Coordinator
LS Medcap GmbH
07.2024 - Current
Trainee Scientific Affairs
LS Medcap GmbH
09.2022 - 06.2024
Project Assistant: Regulatory & Clinical Research
SpotSense Healthcare Private Limited
01.2020 - 08.2020
Master of Science - Biomedical Engineering
Hochschule Furtwangen University
Bachelor's in Engineering (B. E.) - Biomedical Engineering
Rajiv Gandhi Institute of Technology
Similar Profiles
Jose A. DelgadoJose A. Delgado
FULL SPECIALIST ESTHETICIAN at Medcap InstituteFULL SPECIALIST ESTHETICIAN at Medcap Institute
Gary SedillosGary Sedillos
Construction Contract Administrator / Project Cost Control at LS Gallegos & Associates LLCConstruction Contract Administrator / Project Cost Control at LS Gallegos & Associates LLC
Gage StroeningGage Stroening
Deck Hand at LS Marine, IncDeck Hand at LS Marine, Inc
Ihor LishchukIhor Lishchuk
Senior Developer at Camelot ItLabSenior Developer at Camelot ItLab
Christos DelliosChristos Dellios
Dental Laboratory Technician at Vassiliadis Zahntechnik GmbHDental Laboratory Technician at Vassiliadis Zahntechnik GmbH