Kamila Rydzewska
Summary
Accomplished toxicologist and clinical safety specialist with extensive expertise in product safety assessment, regulatory compliance, and toxicological evaluations across cosmetics, medical devices, and OTC drugs. Demonstrates proficiency in Regulation (EC) No 1223/2009, ISO 10993 standards, FDA regulations, REACH and CLP regulations, and IFRA standards. Adept at conducting risk assessments, exposure calculations, biocompatibility studies, and statistical analyses to ensure product safety and compliance. Skilled in project coordination, cross-functional collaboration, leadership, and training initiatives. Committed to advancing innovation while maintaining stringent safety standards within global regulatory frameworks.
Overview
1
1
Certification
8
8
years of professional experience
Work History
Toxicologist & Clinical Safety Specialist
Avon
02.2023 - Current
- Act as lead safety assessor for the Skincare products and Fashion and Home program (air fresheners, candles, cosmetic accessories: brushes, face massager, body massager, cosmetic device).
- Led key toxicology projects to support company development and innovation.
- Conducted comprehensive toxicological and clinical evaluations to ensure product safety and compliance.
- Engaging in analysis and substantiate all clinical claims.
- Working with clinical documentation.
- Preparing Cosmetic Product Safety Reports as per requests from authorities worldwide for product registrations.
- Ensuring the safety of company products and compliance with regulatory demands of cosmetics and other products.
- Performing exposure and risk calculations based on worst-case scenarios.
- Ordering clinical test for safety and clinical claims substantiate reason.
- Writing safety assessments for raw ingredients used in in-house and External Vendor formulas. Provide recommendations on raw materials safe use levels and document safety assessments for support of new and existing ingredients.
- Supporting marketed product-related activities, including raw materials spec revisions, out-of-spec requests, raw materials breakdown changes, temporary approval, and substitution requests.
- Reviewed and analysed reports of adverse reactions to cosmetic products, identifying trends and contributing to safety improvements.
- Maintaining and managing cosmetovigilance documentation and databases.
- Supporting risk assessment activities and corrective actions (e.g., formula changes, label updates, product withdrawal if necessary).
- Handling consumer complaints from a safety and medical perspective.
- Verification and acceptance of labels/packaging of cosmetic products. Adding required warnings.
- Monitoring legislation and standards relevant to cosmetic products.
- Supporting the organization with expertise in toxicology and clinical safety.
- Supporting the organization with expertise in toxicology and clinical safety.
- Participating in the development and maintenance of procedures (SOP), instructions, and templates relevant to toxicology and clinical department.
- Contacting suppliers or external laboratories.
- Company representative in Cosmetic Europe ET Traces Group.
- Conducted training sessions for new employees on company products and services.
Biosafety & Chemical Compliance Specialist
Coloplast
04.2021 - 01.2023
- Performing biological evaluation, planning, and driving execution of these in line with project deliverables.
- Ensuring of biocompatibility of company products and compliance with regulatory demands in relation to the biological safety of medical devices.
- Provided toxicological support through screenings and risk assessments for medical devices, cosmetics, and OTC drugs based on raw materials, extractables, reachable chemicals, and biocompatibility studies.
- Testing the safety of final products by sending them for biological and chemical testing in accordance with ISO-10993.
- Performing exposure and risk calculation based on worst-case scenario or chemical characterization results.
- Prepared and maintained toxicological and biological documentation in accordance with Medical Devices Regulation (MDR), ISO-10993-series, and relevant regulatory guidelines.
- Monitoring and interpretation of legislation and standards relevant to biological and chemical safety.
- Participated in projects and adhered to deadlines according to approved project plans.
- Supporting the organization with expertise in biocompatibility and chemical compliance.
- Created and updated product data sheets for medical devices, cosmetics, and OTC drugs to ensure compliance and clarity of product information.
- Engaged actively in the Tender process to support project bidding efforts.
- Participating in the development and maintenance of procedures, instructions, and templates relevant to biosafety.
- Verification and acceptance of labels/packaging of cosmetic products.
- Preparing Cosmetic Product Safety Report in the framework of Regulation (EC) No 1223/2009.
- Ensuring safety of company products and compliance with regulatory demands in relation to the safety of cosmetic products.
- Implementation of the necessary new cosmetics and OTC drug documentation in USA and Canada.
- Contacting suppliers.
- Conducted training sessions for new employees on company products and services.
Biostatistics Scientist
Pomeranian Medical University
Szczecin
10.2018 - 05.2022
- Statistical analysis of data: a general description of the data, calculation of descriptive statistical parameters, calculation of data distributions.
- Testing statistical hypotheses, (parametric tests, nonparametric tests).
- Correlation between variables.
- Performing linear and logistic regression for data.
- Calculating the threshold of statistical significance.
- Calculating sample size.
- Calculating Intraclass Correlation Coefficient (ICC).
- Writing analytical reports and drawing conclusions.
- Creating databases, working with databases.
- Creating graphics.
- Statistical consultation on projects, scientific publications.
- Active participation in scientific and clinical research.
- Monitoring research and clinical projects.
- Writing scientific articles.
- Collecting materials for scientific publications.
- Designing scientific research.
- Creating multimedia presentations.
- Having didactic classes with students.
- Substantive assistance in writing diploma theses.
Education
Master - Medical Biotechnology
Pomeranian Medical University
Szczecin06-2018
PhD - Medical Sciences
Pomeranian Medical Univeristy
Szczecin12-2023
Bachelor - Medical Biotechnology
Pomeranian Medical University
Szczecin06-2016
Skills
- Knowledge of Regulation (EC) No 1223/2009
- Knowledge of IFRA Standards
- Knowledge of REACH and CLP regulations
- Knowledge of ISO 10993 Standard
- Knowledge of FDA regulations
- Safety and OSHA compliance
- Knowledge of ICH-GCP
- Knowledge of QSAR Toolbox
- Data analysis software
- Organizational and time management skills
- Communication
- Knowledge of medical and therapeutic terminology
- Leadership
- Project coordination
- Cross-functional collaboration
Additional Information
- https://www.linkedin.com/in/kamila-rydzewska-711b821b2/
Software
- Microsoft Ofice
- R
- SAS
- FLO
- Veeva
Languages
Polish
First Language
English
Advanced
C1
Hobbies and interests
- Board games, Music, Books, Travel
Certification
- Going Global - Regional Cosmetics Regulations, 2022-09-01
- Raw materials - significant legislative changes for the cosmetics industry, 2022-07-01
- Documentation of cosmetic products - how to meet the requirements of Regulation 1223/209/EC, 2022-05-01
- Fragrance compositions without secrets - consumer products, 2022-05-01
- Cosmetic product safety assessment for beginners, 2022-03-01
- Preparation of safety data sheet in accordance with the provisions of the regulation 2020/878., 2021-11-01
- The obligations of the entrepreneur resulting from the REACH and CLP regulations, 2021-09-01
- GCP, Good Clinical Practice, 2020-11-01
- Clinical Trials Monitoring - Basics, 2020-11-01
- First Certificate in English, 2019-11-01
RODO
I agree to the processing of personal data provided in this document for realizing the recruitment process pursuant to the Personal Data Protection Act of 10 May 2018 (Journal of Laws 2018, item 1000) and in agreement with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
Timeline
Toxicologist & Clinical Safety Specialist
Avon
02.2023 - Current
Biosafety & Chemical Compliance Specialist
Coloplast
04.2021 - 01.2023
Biostatistics Scientist
Pomeranian Medical University
10.2018 - 05.2022
Master - Medical Biotechnology
Pomeranian Medical University
PhD - Medical Sciences
Pomeranian Medical Univeristy
Bachelor - Medical Biotechnology
Pomeranian Medical University