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Sofia Palm is listed as Regulatory Lead at BSI at BSI, a company with 6300 employees, based in Örebro, Örebro County, Sweden. AeroLeads shows a matched LinkedIn profile for Sofia Palm.
Sofia Palm previously worked as Regulatory Lead at Bsi and Principal Technical Specialist & Certification Scheme Manager at Bsi. Sofia Palm holds Master Of Science, Biotechnology from Linköping University.
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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...
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Working 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.
Promoted 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.
Back 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.
Being 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 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.
Technical 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.
Part 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.
Responsible 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.
Development 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.
Development 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.
Other employees you can reach at bsigroup.com. View company contacts for 6300 employees →
Don Thanh, Ms-Ehsm, Rep
Colleague at BsiSan Jose, California, United States, United States
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DB
David Brain
Colleague at BsiLuton, England, United Kingdom, United Kingdom
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Rick Aquila
Colleague at BsiRamona, California, United States, United States
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Imam Malikz
Colleague at BsiCentral Java, Indonesia, Indonesia
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Ariyan Ahmed
Colleague at BsiDhaka, Dhaka, Bangladesh, Bangladesh
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BM
Bill Mathews
Colleague at BsiLiverpool, England, United Kingdom, United Kingdom
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DG
Diana Granados
Colleague at BsiHerndon, Virginia, United States, United States
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YK
Yoojin K.
Colleague at BsiSeattle, Washington, United States, United States
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JG
John Garcia
Colleague at BsiDenver Metropolitan Area, United States
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Oliver Whear
Colleague at BsiMarch, England, United Kingdom, United Kingdom
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Activities and Societies: Deputy member for the committee of Engineering Biology, Tresurer for the committee of Engineering Biology.
Studied how surface modification with poly(L-lysine)-g-poly(ethylene glycol) of PLGA (poly-lactide-co-glycolic acid) micro particles.
Completed a master thesis in molecular biology and took classes in endocrinology, physiology, immunology, pharmacology and antimicrobial.
Activities and Societies: Tresurer of class committee, Secretary of committee for young scientists (Unga Forskare), Vice presiden of.
Quick answers generated from the profile data available on this page.
Sofia Palm works for BSI.
Sofia Palm is listed as Regulatory Lead at BSI at BSI.
Sofia Palm is based in Örebro, Örebro County, Sweden while working with BSI.
Sofia Palm has worked for Bsi, Tüv Süd, St Jude Medical, and Cerbio Tech / Doxa.
Sofia Palm's colleagues at BSI include Don Thanh, Ms-Ehsm, Rep, David Brain, Rick Aquila, Imam Malikz, and Ariyan Ahmed.
You can use AeroLeads to view verified contact signals for Sofia Palm at BSI, including work email, phone, and LinkedIn data when available.
Sofia Palm holds Master Of Science, Biotechnology from Linköping University.
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