Andrea Bertorelle Email & Phone Number

Sweden

Stockholm, Stockholm County, Sweden

Stockholm, Stockholm County, Sweden

- Leading a team of chemical compliance leads (9 FTEs) and a team of labelling compliance leads (6 FTEs) responsible to ensure timely product regulatory compliance for new product introductions and product changes, and assist in maintaining compliance during the entire product lifecycle;- Facilitating and developing the team members strengths and potential to create engagement, business results as well as a great working environment;- Budget and goal setting;- Driving and contributing to the strategic and long-term agenda for the teams and the department;- Together with the team, drive continuous improvements and developments, implementations and way of working, including change management;- Close collaboration with all relevant stakeholders in a cross-function.- Main areas of expertise: Chemical safety, Childcare articles, Toys, Food Contact items, Textiles, Sustainability (H&M RSLs, REACH, RoHS, CA Prop 65 compliance), Labelling, Complaint handling.

Eindhoven, North Brabant, Netherlands

As part of the Regulatory Affairs, Safety, Compliance and Registrations (RA-SCR), the main responsibilities/activities are:- Leading a team of RA-SCR specialists (10 FTEs) responsible to ensure timely product registrations, regulatory strategy and planning for new product introductions and product changes, and assist in maintaining regulatory compliance.- Acting as a partner of the business and helping to develop business plan from a regulatory perspective. Ensure product safety and compliance for consumer products.- Representing Philips in Global, Regional and National regulatory/standardization committees with focus on chemical safety for children’s product. Prepare, comment, vote on standardization proposal- Key areas of responsibilities: toys and childcare articles safety, food contact products safety, environmental safety, textiles and medical devices.

Eindhoven Area, Netherlands

As part of the Regulatory Affairs, Safety, Compliance and Registrations (RA-SCR), the main responsibilities/activities are: - leading a team of RA-SCR specialists responsible for executing approbation activities for global product registrations;- ensure that the products offered for approbation and registration meet all the requirements in order to bring consumer products to the market, complying with Philips policies, Safety standards and worldwide Regulations;- creating Approbation and Regulatory Submission package per product per country, notarization of approbation documentation, transferring of approbation package to local Country Organizations (CO) and follow up through the whole process;- Responsible for creation of Compliance plans, Compliance Verification, Labeling verification, HBSRA relevant for childcare articles and medical devices under development.- Representing Philips in Global, Regional and National regulatory/standardization committees with focus on chemical safety for children’s product. Prepare, comment, vote on standardization proposals - - Process or swim lane owner in ISE-QMS processes related to Sustainability Compliance (REACH, RoHS, CA Prop 65)

Eindhoven Area, Netherlands

As part of the Function and Product Development department (R&D), the main responsibilities/activities are:- Interface between Product Development and Regulatory Affairs;- Responsible to handle for the end to end all regulatory / safety requirements and matters related to Mother & Childcare business;- Subject Matter Expert (SME) for product & regulatory requirements and medical devices development processes;- SME for sustainability/environmental requirements (REACH, RoHS, Cal Prop 65...) processes;- Process owner for compliance of sustainability (chemical) requirements;- Support the Development team in the correct interpretation and implementation of product requirements during the different phases of the product development; - Main point of contact for third party testing;- Support the Development team during the update of chemical and biological safety risk assessments;- Support the RA and Development team in the creation and review of submission files prior regulatory submissions, including drafting deficiency questions from regulators;- Support the QA and Development team with solving product non-conformities;

Eindhoven Area, Netherlands

- Identify all relevant regulations and requirements applicable to medical devices and IVD.- Advise internal stakeholders regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.- Review and approve advertising, promotional items and labeling for regulatory compliance.- Create detailed written regulatory plans that can be used to target domestic and international shipment dates- Develop and prepare product registration submissions file (EU, U.S, Canada and selected worldwide locations) for Medical Devices / IVDs according to the relevant standards, primarily ISO 13485 and 21 CFR 820.- Review and approve advertising, promotional items and labeling for regulatory compliance.- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project. - Work cross-functionally with QA, R&D and Marketing teams throughout the Product Development and Post Market process.- Vigilance and Postmarket Surveillance: Manage potential reportable complaints.

Eindhoven Area, Netherlands

- Identify all applicable regulations and verify that the design outputs are compliant.- Manage safety and regulatory related affairs (incl Sustainability).- Check instruction manuals and artworks on regulatory compliance.- Manage the safety complaint handling process.- Represent Philips Consumer Lifestyle in international regulatory bodies on specific subjects; Member of CEN/TC252/WG5 Feeding, drinking, sucking and similar functions, representing NEN (Dutch mirror committee);- Choose appropriate certification test labs;- Manage and support local approbations/registrations/submissions;- Responsible for quality of safety risk assessments (incl. biological and chemical safety assessments);- Contribution in substantiation of product claims.- Ensure that project teams have the correct interpretation of standards.- Regulatory domains of expertise: Childcare articles and Toys (2001/95/EC GPSD, Dir. 2009/48/EC TSD, CPSIA) Food Contact (Reg. EU1935/2004, Reg. EC10/2011, GMP, FDA 21 CFR), Sustainability (REACH, RoHS), Biocompatibility of medical devices (ISO10993 series);- Main areas of interest: Regulatory and Clinical Affairs;

Delft, South Holland Province, Netherlands

Childcare articles expert representing NEN at WG5/TC252 TG1-2, WG6/TC52 TG1

Grandate, Como, Italy

- Study and application of European Directives, national and international standards and regulations (REACH, Reg. EC 1935/2004, Reg. EU 10/2011, EN series standards covering "Childcare articles")- Management of the activities aimed to allow the exportation of the Chicco Nursing products and support Artsana sister companies and distributors during the product registrations and import licences;- Active contribution during the product development processes defining quality and safety requirements;- Management and coordination of laboratory tests in order to get the homologation of the product under development;- Managing of Non-Conformities and complaints from the market;- Product Categories: Nursing items (soothers and accessories, feeding bottles, teats and drinking equipments, weaning items, teethers), Food Contact items;

Grandate, Como, Italy

- Study and application of European Directives, national and international standards and regulations (REACH, Reg. EC 1935/2004, Reg. EU 10/2011, Dir. 2009/48/EC, EN series standards applicable to Toys, Nursing, Food Contact and Juvenile items) - Regulatory Assistance and Support in the definition of safety requirements for new products under development;- Due Diligence testing: Daily interface with national and international certification laboratories for the execution of Chemical and Physical-Mechanical analysis on child care articles, clothing, shoes and articles intended to come in contact with food;- Contribution in the periodical budgeting activities for the reference business area;- Product Categories: Juvenile products (Strollers, Highchairs...), Nursing items (Soothers, Baby Bottles,...), Toys, Clothing and Shoes.

Grandate, Como, Italy

- Study and application of the standards applicable to the reference product category (EN1400, EN14350, EN14372, EN12586, Reg. EC 1935/2004); - Partecipation at the different product development phases contributing at the definition of the product quality and safety; - Definition of the quality plans and quality testing and validation protocols for verifying and validate the new products under development; - Certification of new products; - Product homologation for specific international markets;- Internal lab testing activities; - Monitoring of Non Conformities, returns and consumer claims reporting defectiveness.

Grandate, Como, Italy

- Study and application of the standards applicable to the reference product category (EN1888, EN14988, EN12790, EN13209...); - Partecipation at the different product development phases contributing at the definition of the product quality and safety; - Definition of the quality plans and quality testing and validation protocols for verifying and validate the new products under development; - Certification of new products; - Product homologation for specific international markets;- Internal lab testing activities; - Monitoring of Non Conformities, returns and consumer claims reporting defectiveness.

Microbiology Lab Technician

Place: Public Health Dept.Job Activities: Food Safety - Microbiological analysis of foods, water and public environments.

Master'S Degree, Medical Biology, 108/110

Bachelor’S Degree, Molecular Biology (Curriculum Bio-Medicine)