Andrea Bertorelle
Stockholm
Summary
Offering over 15 years of experience in Product Compliance, Safety, and Regulatory within the consumer products and medical device industry, this candidate has established a strong international profile. Expertise spans various areas including apparel, footwear, textile products, toys and childcare articles, home/household products, and food contact products.
Regulatory expertise: General Product Safety Regulation (GPSR) Reg. EU 2023/988, REACH Reg. EC 1907/2006 (SVHC, Annex XVII restrictions), Directive 2011/65/EU (RoHS), Reg. EU 1935/2004, Reg. EC 10/2022, TSD Directive 2009/48/EC, California Proposition 65, CPSIA, CCPSA, and FDA regulations.
Overview
16
16
years of professional experience
Work History
Product Compliance Manager - Chemical & Labeling
H&M Group
10.2021 - Current
- Ensuring Chemical & Labeling Regulatory Compliance for consumer products.
- Leading a team of chemical compliance (9 FTEs) and labeling compliance specialists (7 FTE).
- Team members' personal development.
- Budget and goals setting.
- Driving and contributing to the company regulatory strategy.
- Collaboration with cross-functional stakeholders.
Head of Regulatory Affairs, Safety & Compliance
Royal Philips
04.2019 - 09.2021
- Leading a team of regulatory specialists (12 FTEs).
- Developing and implementing global regulatory strategy.
- Acting as a regulatory business partner.
- Representing Philips in regulatory/standardization committees (TC252/WG5/TG1-TG2).
- Prepare, comment, vote on standardization proposals.
Safety, Compliance & Regulatory Manager
Royal Philips
12.2013 - 03.2019
- Identify all applicable regulations and compliance verification.
- Compliance verification of instruction manuals and packaging.
- Manage the safety complaint handling process.
- Choose appropriate certification test labs and manage them.
- Manage product registrations.
- Responsible for quality of safety risk assessments.
Product Compliance & Regulatory Specialist
Artsana Group
09.2008 - 11.2013
- Study and application of European Regulations, Directives, National and International standards.
- Definition of quality requirements for products under development.
- International Registrations.
- Management of Non-Conformities.
- Management and coordination of laboratory tests.
Education
Master of Science - Medical Biology
University of Florence
Florence, ItalyBachelor of Science - Molecular Biology - Biomedicine
University of Padua
Padua, ItalySkills
- Communication
- Teamwork
- Problem-solving
- Organizational strategy
- Positive mindset
Languages
Italian
Native language
English
Proficient
C2
Hobbies
- My dogs
- Cooking & wine tasting
- Travelling
- Music
Timeline
Product Compliance Manager - Chemical & Labeling
H&M Group
10.2021 - Current
Head of Regulatory Affairs, Safety & Compliance
Royal Philips
04.2019 - 09.2021
Safety, Compliance & Regulatory Manager
Royal Philips
12.2013 - 03.2019
Product Compliance & Regulatory Specialist
Artsana Group
09.2008 - 11.2013
Master of Science - Medical Biology
University of Florence
Bachelor of Science - Molecular Biology - Biomedicine
University of Padua
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