Sofia Palm Email and Phone Number
Highly organized and structured engineer with a passion for quality. A curious team player with extensive experience in medical devices and regulatory affairs. Motivated by a profound belief in continuous improvement and delivering results with the customer in focus. Truly inspired by people interactions and always learning.Specialties: Medical Device Regulation (MDR), Medical Device Directive (MDD), UK MDR 2002, ISO 13485, Regulatory Affairs, QMS, Pacemaker and ICD technology, Lean Orange Belt certification, Green Belt Six Sigma certification, Lean manufacturing, Cleanroom technology, EtO sterilization technology...
Bsi
View- Website:
- bsigroup.com
- Employees:
- 6300
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Regulatory LeadBsi Jul 2024 - PresentWorking as a Regulatory Lead in the Global Regulatory Compliance Team providing regulatory support to the Head of Notified Body (NB)/Approved Body (AB) for the applicable regulation. Main schemes being the Medical Device Regulation 2017/745 (MDR) and the UK MDR 2002 for medical devices. Responsible for the conformity assessment and certification activities related to the NB/ABs scope of designation and ensuring that the NB/AB operates in compliance with the applicable regulatory requirements.
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Principal Technical Specialist & Certification Scheme ManagerBsi Oct 2023 - Jun 2024Promoted to Principal Technical Specialist and Certification Scheme Manager. Working as a mentor in the Vascular Team with expertise as a Scheme Manager, Technical Specialist, Clinical Evaluation Specialist and Certification Decision Maker. Main schemes being the Medical Device Regulation 2017/745 (MDR), the UK MDR 2002 as well as the Medical Device Directive 93/42/EEC (MDD).
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Senior Technical Specialist & Certification Scheme ManagerBsi Jun 2023 - Sep 2023Back as a Senior Technical Specialist and Certification Scheme Manager as well as Clinical Evaluation Specialist and Certification Decision Maker in the Vascular Team. See additional details below. Main schemes being the Medical Device Directive 93/42/EEC (MDD), the Medical Device Regulation 2017/745 (MDR) and also the UK MDR 2002.
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Medical Device Expert & Product ReviewerTüv Süd Apr 2022 - May 2023Being part of a small team at TÜV SÜD Denmark MHS (Medical Health Services) building up a Conformity Assessment Body (CAB) to become Notified Body for Medical Devices and the Medical Device Regulation 2017/745 (MDR). -
Senior Technical Specialist & Certification Scheme ManagerBsi Sep 2020 - Mar 2022Senior Technical Specialist and Certification Scheme Manager in the Vascular Team. As below and also working as a Clinical Evaluation Specialist and Certification Decision Maker conducting reviews of clinical documentation per the Medical Device Directive 93/42/EEC (MDD) and the Medical Device Regulation 2017/745 (MDR) and making final certification decisions for the Notified Body. Conducting training of new employees as scheme managers and technical specialists in the Vascular Team.
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Technical Specialist & Certification Scheme ManagerBsi Jun 2010 - Aug 2020Technical Specialist and Certification Scheme Manager in the Vascular Team. Responsible for CE certification of medical devices as per the Medical Device Directive 93/42/EEC (MDD) and the Medical Device Regulation 2017/745 (MDR) and management of a portfolio of medical device CE marking certification schemes for Vascular Team clients. Conducting reviews of design dossiers, technical files and technical documentation for devices predominantly in the vascular area.
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Product SpecialistSt Jude Medical Aug 2009 - Apr 2010Part of the technical support team handling questions from sales representatives, physicians and patients regarding products for bradycardia and tachycardia; pacemakers, ICDs, leads, CRT-devices etc. -
Process EngineerSt Jude Medical Sep 2005 - Jul 2009Responsible for the cleanroom process in terms of quality aspects and applicable standards. Working with the sterilization process (EtO) with quality issues and daily routine work. Certified orange belt and green belt in Six Sigma continuous improvement. Area of improvements: cycle time in pace production and cleanroom technology.
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Material Technology EngineerSt Jude Medical Jun 2004 - Jul 2005Development of new technologies and testing of new materials for pacemaker leads in both new technology projects and product development projects. Working with six sigma methodology and continuous improvements.
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Development EngineerCerbio Tech / Doxa Jan 2003 - May 2004Development of a bioactive ceramic bone implant for vertebral fractures and for dental use. Implementation of quality system. Introduction and validation of manufacturing procedures in newly built production area.
Sofia Palm Education Details
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Biotechnology -
Biomaterials -
Molecular Biology -
Högbergsskolan/Vbu, LudvikaNatural Science -
Gärdeskolan, LudvikaCompulsory School
Frequently Asked Questions about Sofia Palm
What company does Sofia Palm work for?
Sofia Palm works for Bsi
What is Sofia Palm's role at the current company?
Sofia Palm's current role is Regulatory Lead at BSI.
What schools did Sofia Palm attend?
Sofia Palm attended Linköping University, Eth Zürich, Aston University, Högbergsskolan/vbu, Ludvika, Gärdeskolan, Ludvika.
Who are Sofia Palm's colleagues?
Sofia Palm's colleagues are Laura Manning, Oliver Whear, Alex Sanchez Heredia, Debra Castillo, Kristen Murray, Darnell Robertson, Anil Kadam.
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