Regulatory Affairs Medical Device

MANITA

Bellevue, WA-*****

Mobile no. +1-425-***-****

Email ID: *****************@*****.***

SUMMARY:

Dedicated and Passionate Regulatory Affairs professional adept at coordinating and tracking regulatory protocols and experienced in complaint and CAPA management, FDA Quality system Regulation, Medical Device Regulation (MDR) Process, 21 CFR Part 820, ISO, Process & Design controls, Design History File, resolving regulatory and client queries.

Experienced with preparations and submissions of 510(k) submissions, PMS (Post market Surveillance), PMA, international documents and performing audits.

Working with regulatory affairs team on regulatory operations, regulatory submissions, compliance and review. Responsible for supporting new product regulatory submissions, updating existing technical documentation and support of global product registrations. SKILLS:

Knowledge on MS word, Excel.

Good Communication Skills – Verbal, Non-Verbal, Business Communication

Presentation Skill – Delivered presentations at various events and to the clients

Team Player – Ability to establish and maintain effective working relationships with coworkers, managers and clients

LICENSE:

Medical Assistant Phlebotomist-MAP license from USA.

Pharmacist license from India.

CERTIFICATION:

PCDRA (Professional Certificate in Drug Regulatory Affairs) - DNASYS Academy of Health Sciences, USA. THERAPEUTIC AREA EXPERTISE:

Oncology, Infectious Disease and Cardiology.

WORK EXPERIENCE

VFS Global International

Officer Operations July, 24 – till date

Scrutinize, digitalization, processed the applications.

Maintain the documentation, dispatch the applications Akums Drugs & Pharmaceuticals Ltd.

Regulatory Affairs Specialist March,21 - March,22

Worked on SUGAM Portal (SUGAM portal is a single window interface for stakeholders to access the online services provided by CDSCO (Regulatory body of India)) for Permission to Manufacture, Marketing and Import or to Conduct Clinical Trials.

Registration, Preparation, Compilation and Review of Common Technical Dossier (CTD).

Review of API (Active Pharmaceutical Ingredient) and Finished Product Documents.

Preparation and review of dossier for domestic market.

DCG(I) submissions, Answering to DCG(I) queries.

CTD filling (Paper filling), Document Management System, SOP & workflow writing and Review, and Regulatory Compliance.

Preparation and review of Package insert (Patient Information Leaflet) and labeling information.

Application of different licenses (Manufacturing, Import & Clinical Trial Licenses). Handling finished doses forms like tablets, capsules, Injections, oral syrup, suspension etc.

Preparation of complete dossier including manufacturing, process validation report, STS, STP, Packaging, Stability Report, Product Development Report. solution of query. Works in various part of CTD

Florencia Healthcare

Regulatory Officer July,19 - February,22

Worked in various part of CTD and ACTD.

Developed and implemented QMS programs to transition Quality Systems to the ISO 13485 and the transition of Quality Systems to the New Medical Device Regulation (MDR) and Quality system regulations.

Reviewed new product protocols related to verification and validation, risk assessment. Implemented QSR Regulations, MDR, and ISO Standards.

Compilation of various pharmacological, pre-clinical & toxicological data based on published literature.

Review and preparation of Package insert and labeling information.

Maintained regulatory documentation including submissions to and correspondence with each governing authority.

Aadhar Health Institute (NABH Certified)

Pharmacist October,14 – August,17

Worked on Biosafety cabinet in Chemotherapy Department.

Handled the biosafety Cabinet with precaution.

Spills handled by removing the contaminated absorbent towel and dispose it into a biohazard beg. PAPER PUBLICATIONS

Manita, Deep A, Vikram, Rana AC, Regulation and Clinical Investigation of Medical Device in European Union. Applied Clinical Research, Clinical Trials & Regulatory Affairs (Bentham Science Publishers).

Manita, Deep A, Vikram, Rana AC. Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update. Recent Innovations in Chemical Engineering (Bentham Science Publishers)

CLINICAL RESEARCH KNOWLEDGE AND SKILLS

Clinical research fundamentals

ICH-GCP and Indian GCP

Good Data management practices

Pharmacovigilance (PV) Basics

EDUCATION:

Post Graduate in Regulatory Affairs (RA)) on 2019 from Chaudhary Bansi Lal University, Bhiwani with 8.23 GPA out of 10.00.

Graduate in Pharmacy on 2014 from Guru Jambheshwar University of Science & Technology, Hisar.

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