Senior Regulatory Affairs Specialist at Siemens Healthineers
Hatfield, Pennsylvania
Teacher @ Sage Day High School From September 2008 to August 2011 (3 years) Regulatory Affairs Specialist @ KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS) · Lead cross-functional effort to bring company to Unique Device Identification (UDI) compliance for Class I & II medical devices.· Conducted regulatory assessments for new products, product modifications, marketing claims, and...
Teacher @ Sage Day High School From September 2008 to August 2011 (3 years) Regulatory Affairs Specialist @ KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS) · Lead cross-functional effort to bring company to Unique Device Identification (UDI) compliance for Class I & II medical devices.· Conducted regulatory assessments for new products, product modifications, marketing claims, and federal/state regulations to determine impact on the broader organization.· Developed regulatory strategies for domestic and international product deployment. · Investigated and submitted device malfunction and adverse event reports to FDA, Health Canada, and EU Notified Body· Updated and maintained CE Technical Files.· Provided regulatory support and guidance to end-users for state radiation control requirements.· Compiled and submitted FDA 510(k) and Health Canada product submissions· Compiled and submitted international product registration dossiers. From March 2016 to July 2017 (1 year 5 months) Greater Philadelphia AreaRA / QA Associate Specialist @ KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS) - Assisted in document compilation for product 510(k) submissions- Gathered documentation for and maintained product Technical Files- Managed Certificates to Foreign Governments (CFG).- Compiled and submitted global registration dossiers for 2D & 3D Imaging product.- Ensured Quality System audit-readiness. From June 2014 to March 2016 (1 year 10 months) Greater Philadelphia AreaDocument Control Specialist (Quality Assurance/Regulatory Affairs) @ KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS) - Compiled and submitted global registration dossiers for 2D & 3D Imaging products- Wrote and revised standard operating procedures to enhance Quality System- Tested, validated, and implemented new electronic forms in MasterControl to streamline processes- Created and executed action plans for Corrective and Preventive Actions (CAPA) to rectify identified problems in the Quality System- Built and revised Bill of Materials (BOM) and Material Masters to improve control of material in the Quality System- Processed/facilitated Engineering Change Notices for product releases and improvements- Collected, stored, and maintained Device History Records, Medical Device Reports, and Quality/Engineering documents to ensure the Quality System is audit-ready. From January 2012 to June 2014 (2 years 6 months) Hatfield, PARegulatory Affairs Associate @ KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS) - Successfully completed and obtained FDA termination for three Field Corrective Actions (Recalls) - Communicated monthly Field Corrective Actions status updates to the FDA- Investigated customer complaints involving potential adverse events for Medical Device Reports (MDR) From September 2011 to January 2012 (5 months) Hatfield, PASenior Regulatory Affairs Specialist @ Siemens Healthineers Malvern, Pennsylvania, United StatesRegulatory Affairs Specialist @ Siemens Healthineers - Submit 510(k)s and obtain product clearance from US FDA- Submit MDL applications and obtain approval from Health Canada- Review and approve medical device advertising and promotional material for the US From July 2017 to February 2020 (2 years 8 months) Malvern, PA
Sage Day High School
Teacher
September 2008 to August 2011
KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS)
Regulatory Affairs Specialist
March 2016 to July 2017
Greater Philadelphia Area
KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS)
RA / QA Associate Specialist
June 2014 to March 2016
Greater Philadelphia Area
KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS)
Document Control Specialist (Quality Assurance/Regulatory Affairs)
January 2012 to June 2014
Hatfield, PA
KaVo Kerr Group (Imaging Sciences International/ Gendex/ DEXIS)
Regulatory Affairs Associate
September 2011 to January 2012
Hatfield, PA
Siemens Healthineers
Senior Regulatory Affairs Specialist
Malvern, Pennsylvania, United States
Siemens Healthineers
Regulatory Affairs Specialist
July 2017 to February 2020
Malvern, PA
What company does Martin Rajchel work for?
Martin Rajchel works for Sage Day High School
What is Martin Rajchel's role at Sage Day High School?
Martin Rajchel is Teacher
What industry does Martin Rajchel work in?
Martin Rajchel works in the Medical Devices industry.
Who are Martin Rajchel's colleagues?
Martin Rajchel's colleagues are Irina Kotenko, Paulo Renato Volpe Carvalho, Rosario Sciacca, Santosh Kumari, Shadi Vaezzadeh, Sam Mokati, Rupert Borman, Ben Pronk, Martin Hagenbeek, and Michiel de Bruijn
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