Rasika D.-RA/QA Expert | Medical Devices | ISO 13485 & 14971 | ICH GCP | Medical Coding | Polymer R&D & Nanotechnology
Check rate
Experience
Manuscript Consultant
R.D.V.V - Jbp
- Developed and managed content across diverse platforms, adapting tone, structure, and style to meet audience expectations and editorial standards
- Conducted in-depth research to ensure content accuracy, relevance, and alignment with client objectives and subject-matter requirements
- Edited and refined client manuscripts and drafts to improve clarity, narrative flow, coherence, and reader engagement
- Managed multiple concurrent content projects, prioritizing tasks and meeting tight deadlines while upholding high-quality standards
- Provided uncredited editing support for various publications, ensuring polished, consistent, and publication-ready final manuscripts
Quality Associate
BBSSW Medical Company
- Coordinated regulatory procedures and processes for medical devices, ensuring adherence to quality service functions and product portfolio standards
- Maintained comprehensive regulatory documentation archives, upholding ISO 13485, ISO 14971, and 21 CFR compliance with SOPs and regulatory mandates
- Conducted in-depth research and analysis for the timely preparation of regulatory submissions, including FDA premarket notifications and eCTD applications
- Established objectives and prioritized tasks in alignment with ISO 13485, FDA 21 CFR 820 and 11, ISO 14971, CAPA, EMEA, and ICH guidelines
- Engaged in cross-functional problem-solving sessions, applying expertise in quality principles and analytical skills
- Collaborated with manufacturing teams to enhance production processes, focusing on quality improvement and efficiency gains
- Utilized quality control software to monitor, track, and analyze product data, contributing to continuous quality improvement
- Consistently updated and managed quality control records and reports, ensuring accuracy and reliability of quality data
Doctoral Researcher
Wiley
- Conducted comprehensive research, resulting in the publication of manuscripts in prestigious journals and demonstrating exceptional skills in scientific publishing, editing, and presentation
- Increased research efficiency by optimizing data collection and analysis processes
- Collaborated with external researchers to create a diverse network for knowledge exchange
Research Associate
CSIR (PUSA) Institute
- Specialized expertise in polymer-controlled drug delivery systems, with a focus on synthesis, characterization, and nanotechnology
Senior Research Associate, Enhanced Regulatory Reporting & Workflow
CSIR (PUSA) Institute
- Specialized in the graft copolymerization of cellulose-based membranes to improve their antimicrobial properties for innovative food packaging solutions
- Developed innovative research strategies for improved data collection and analysis, leading to higher-quality results
- Created high-quality, professional articles for submission to scientific publications
- Published articles in peer-reviewed journals that enhanced the institution's reputation and contributed to scientific advancement
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Media and Entertainment, Healthcare, Biotechnology, Pharmaceutical, Chemical, and Food and Beverage.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Research and Development, Quality Assurance, Project Management, and Product Development.
Summary
Independent QA/RA Consultant & Scientific Advisor
With over a decade at the intersection of high-impact R&D and quality assurance, I turn complex scientific breakthroughs into safe, compliant, market-ready medical technologies. My practice combines 10+ years of pioneering research in drug-delivery systems and nanotechnology with rigorous industrial experience in quality & regulatory affairs. I provide immediate bandwidth and technical precision to medical device manufacturers, biotech startups, and life science enterprises, guiding them through strict global regulatory pathways (EU MDR, ISO, FDA).
- How I Support My Partners & Clients
Quality, Compliance & Regulatory Expertise: I make sure your transition from laboratory R&D to industrial manufacturing is smooth, highly auditable, and fully compliant with global mandates.
- Standards: Deep proficiency in ISO 13485 (QMS), ISO 14971 (Risk Management), and EU MDR requirements.
- Clinical Integrity: Experienced in medical coding and certified in ICH GCP to maintain absolute data integrity and maximize patient safety.
- Drug Safety: Strong background in pharmacovigilance, ensuring the long-term reliability of advanced drug-delivery systems.
Research & Academic Leadership:
I have dedicated over 10 years to advancing the frontiers of nanomedicine, focusing on the design and characterization of polymeric nanocarriers (such as PLGA, PCL, and Chitosan) for controlled, targeted drug release [PMC, MDPI].
Publications: Authored 10 peer-reviewed papers in renowned international scientific journals.
Author: Authored a technical book (LAP) on next-generation therapeutic solutions.
Technical Specialties: Stimuli-responsive systems and nanoparticle functionalization for precision medicine. I am passionate about driving cutting-edge, rigorously validated, and safe healthcare innovation for global patient care.
Let's streamline your upcoming submission goals. Connect with me directly here on LinkedIn via Direct Message to discuss how we can support your project pipeline or clear your documentation backlog.
Core Competencies: Process Validation | Quality Management Systems (QMS) | Nanotechnology | Polymer Science | ISO 13485 | ISO 14971 | ICH GCP | Pharmacovigilance | Medical Coding | R&D Strategy | EU MDR I Regulatory Affairs IScientificPublications
Skills
- Regulatory Issues
- Pharmacovigilance And Drug Safety
- Quality Assurance In The Medical Industry
- Polymer Drug Delivery And Nanotechnology
- Iso 13485, Iso 14971, 21 Cfr
- Documentation Review
- Validation Protocols
- Quality Management System
- Medical Coding
- Medical Billing
- Revenue Cycle Management
- Regulatory Compliance
- Healthcare Administration
- Scientific Publication
Languages
Education
R.D.V.V - Jbp
Ph.D. · Chemistry · Jabalpur, India
R.D.V.V - Jbp
Master of Science · Chemistry · Jabalpur, India
R.D.V.V - Jbp
Bachelor of Science · Microbiology · Jabalpur, India
Certifications & licenses
Diploma in Medical Coding and Billing
Alison
ISO 13485:2016 - Quality Management Systems For Medical Devices
ALISON
Medical Device Standards, Specifications and Testing
RAPS
Extended International Pharmacovigilance And Argus Safety Certification
CCRPS
Medical Device And Process Validation
UDEMY
Pharma Dra
UDEMY
Statistics
Experience
Global experience
Expertise
Qualifications
Frequently asked questions
Have questions? Find more information here.
Rasika is based in Hamburg, Germany and can operate in on-site, hybrid, and remote work models.
Rasika speaks the following languages: English (Native), German (Advanced).
Rasika has at least 9 years of experience. During this time, Rasika has worked in at least 5 different roles and for 4 different companies. The average length of individual experience is 2 years and 10 months. Note that Rasika may not have shared all experience and actually has more experience.
Based on recent experience, Rasika would be well-suited for roles such as: Manuscript Consultant, Quality Associate, Doctoral Researcher.
Rasika's most recent position is Manuscript Consultant at R.D.V.V - Jbp.
In recent years, Rasika has worked for R.D.V.V - Jbp and BBSSW Medical Company.
Rasika is most experienced in industries like Media and Entertainment, Healthcare, and Biotechnology. Rasika also has some experience in Pharmaceutical, Chemical, and Food and Beverage.
Rasika is most experienced in business areas like Research and Development, Quality Assurance, and Project Management. Rasika also has some experience in Product Development.
Rasika has recently worked in industries like Media and Entertainment and Healthcare.
Rasika has recently worked in business areas like Quality Assurance, Project Management, and Research and Development.
Rasika holds a Doctorate in Chemistry from R.D.V.V - Jbp, a Master in Chemistry from R.D.V.V - Jbp and a Bachelor in Microbiology from R.D.V.V - Jbp.
Rasika has 7 certificates. Among them, these include: Diploma in Medical Coding and Billing, ISO 13485:2016 - Quality Management Systems For Medical Devices, Medical Device Standards, and Specifications and Testing.
Rasika is immediately available full-time for suitable projects.
Daily rate distribution
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Average rates for similar positions
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 6 Nov 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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