ANVI SUNILKUMAR BHAVSAR
Kitchener
Summary
To secure a challenging position in Regulatory Affairs in a reputed organization to expand learning, knowledge, and skills.
Overview
2
2
years of professional experience
Work History
Regulatory Affairs Senior Officer
Meril Pvt. Ltd.
09.2021 - 11.2023
- .Preparation and updating of regulatory submissions, focusing on the documentation required for CE marking.
- Review all data before submission to regulatory agencies.
- Co-ordinate with QA/production/development/marketing/clinical department for documents required for regulatory submissions, focusing on CE marking.
- Manage and facilitate the activities related to the Quality Management System documentation as per ISO 13485.
- Develop & maintain regulatory knowledge, especially of European regulations.
- Update and maintain the technical master files of all the products.
- Quality update and maintain the Design history files of all the products
- Successfully managed EUDAMED submissions for both MDD and MDR-compliant products, demonstrating proficiency in navigating the evolving regulatory landscape.
- Effectively liaised with cross-functional teams to gather and organize required data, ensuring accurate and timely submissions.
- Demonstrated a strong understanding of medical device regulations, contributing to the seamless transition from MDD to MDR.
- Played a pivotal role in ensuring compliance with regulatory requirements, thereby facilitating the market access of medical devices.
- Demonstrated a comprehensive understanding of regulatory requirements and ensured meticulous documentation to meet compliance standards.
- Basic knowledge of UKCA certification processes and standards.
- Familiarity with the requirements and procedures involved in obtaining and maintaining UKCA certification for products.
- Ability to navigate UKCA guidelines and regulations to ensure compliance with industry standards.
Education
Post Graduation - Regulatory Affairs
Conestoga College
Kitchener, ON2024
Bachelor of Science - Microbiology
Veer Narmad South Gujarat University
India2020
Higher Secondary School - Science
Gujarat Secondary And Higher Secondary Education Board
India2017
Secondary School -
Gujarat Secondary And Higher Secondary Education Board
India2015
Skills
- Technical documentation for CE Marking as per MDD 93/42/EEC and 2017/745
- EUDAMED
- Risk Management
- EU MDR
- MS Word and PowerPoint
- Working efficiently to meet quick deadlines
- Ability to work on multiple projects
- Capable of working under pressure
- Communication
- Adaptability and Quick Learner
Areas Of Interest
- Regulatory Affairs
- Quality Assurance
Internship
R.K.Desai Clinical Pathology Laboratory, Valsad, Gujarat India 04/05/2021 to 08/13/2021,
Conducted diagnostic tests and assays under supervision, including blood counts, urinalysis, and microbiological cultures. Maintained quality control measures, calibrated equipment, and ensured the accuracy of test results. Handled various biological samples, labeled, stored, and processed them according to laboratory protocols. Analyzed and interpreted test results, identified abnormalities, and reported findings accurately to healthcare professionals. Collaborated with laboratory staff and adhered to regulatory guidelines, ensuring compliance with safety regulations and privacy laws. Proficient in operating various laboratory equipment, including those used in biochemistry, hematology, and other diagnostic fields. Skilled in performing tests such as blood chemistry analysis, complete blood counts (CBC), and coagulation studies using automated analyzers and manual methods. Familiarity with maintaining and calibrating equipment to ensure accurate test results and adherence to quality control standards.
Certifications Courses
Certificate course by Public Health Agency of Canada:
- Understanding How Medical Devices are regulated in Canada by Health Canada
- Pathogen Risk Assessment by Public Health Agency of Canada
- Local Risk Assessment by Public Health Agency of Canada
State Level Skill Workshop Series for Medical & Paramedical Professionals&Students at Parul University, Vadodara, Gujarat
Certificate Course:
- Basic techniques for specimen processing and diagnosis in clinical microbiology
- Techniques of suturing, bandaging, dressing, and orthopedic procedures
- Immuno-histochemistry
- Electrocardiogram
- Hospital infection control practices
- Basics of MRI & sequences
Languages
English
Hindi
Gujarati
Disclaimer
I hereby declare that the above mentioned information is true to the best of my knowledge.
Timeline
Regulatory Affairs Senior Officer
Meril Pvt. Ltd.
09.2021 - 11.2023
Post Graduation - Regulatory Affairs
Conestoga College
Bachelor of Science - Microbiology
Veer Narmad South Gujarat University
Higher Secondary School - Science
Gujarat Secondary And Higher Secondary Education Board
Secondary School -
Gujarat Secondary And Higher Secondary Education Board
Similar Profiles
Mukesh KumarMukesh Kumar
TSM at Meril Lifesciences Pvt. Ltd.TSM at Meril Lifesciences Pvt. Ltd.
Indu SachdevaIndu Sachdeva
Manager-Business HR, North India at Meril Life Science India Pvt LtdManager-Business HR, North India at Meril Life Science India Pvt Ltd
Hirenkumar LadHirenkumar Lad
Assistant Manager at Meril Lifescience Pvt. LtdAssistant Manager at Meril Lifescience Pvt. Ltd