Jorge F.
Medical device regulatory manager at Altacor- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
Spanish Native or bilingual proficiency
-
Portuguese Professional working proficiency
-
English Native or bilingual proficiency
Topline Score
Bio
Credentials
-
BSI CH/157 mechanical contraceptive committee expert member
BSISep, 2019- Oct, 2024 -
ISO TC 157 mechanical contraceptive committee expert member
ISO - International Organization for StandardizationSep, 2019- Oct, 2024 -
BSI Registered Lead Auditor
British Standard InstituteDec, 2012- Oct, 2024 -
IRCA Certificated Lead Auditor
IRCAJul, 2012- Oct, 2024 -
HABC level 3 awared in HACCP for food manufacturing (QCF)
Highfield awarding body for complianceMar, 2012- Oct, 2024
Experience
-
Altacor
-
United Kingdom
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Medical device regulatory manager
-
Jan 2021 - Present
RA project manager: Identify and initiate areas for process improvement and manage changes as required. Adopt and manage any projects relevant to the role. Prioritise, plan and monitor allocated projects against defined timelines.Person Responsible for Regulatory Compliance in the UK and other markets: Provide full regulatory and technical support and expertise to the board and cross-functional project teams as required and keep the company up to date regarding new or changes in regulations related to UK, EU, USA, Israel and Swiss and other markets applicable to Medical Devices; Plan, prepare and submit product dossiers of low and high risk Medical Devices to Notified Bodies and Regulators to distribute in different markets;QMS Responsible Person: Implement QMS and make it compliant with ISO 13485, FDA, UK MDR and EU MDR: Including but not limited to control of documents, Control of customer complaints, plan management review, change control, risk control, Review of Post-Market surveillance, Review of clinical evaluation, Control of audit programme, Control of software validation, Review of suppliers, Control of non-conforming products and review of labelling; Manage, liaise and review performance with relevant service providers; Provide any training needed to personnel; Manage medical devices departmental budgets and resources; Ensure Altacor and its products are compliant with standards, quality requirements, marketing authorisations and regulations; Support other group Pharmaceutical companies with SOPs, c-GMP, GDP, QA, regulatory compliance and Pharmacovigilance activities;QMS Lead Auditor, Audit Trainer & Audit Programme Manager: Lead internal audits, generate reports, maintain and control audit programmes, audit suppliers, give internal auditor training courses to other employees, review other internal lead auditor competencies and performance;
-
-
-
Pasante Healthcare Ltd.
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
QA Manager
-
Jan 2017 - Jan 2022
QMS RP: Manage ISO 13485, KM, NF Mark, CE certification; Including but not limited to control of documents, control of customer complaints, PV, plan management review, change control, review of labelling, control of risk management, control of software validation, review of suppliers performance, review of PMS, review of clinical evaluation, control of software validation, Review of suppliers and Control of non- conforming products; Department and Team Manager: Manage departmental budgets and resources; Manage a team reporting directly to me; Manage QA, and Technical Department; Provide any training needed to personnel; Manage departmental budgets and resources; Manage and liaise with relevant service providers; PRRC: Provide full regulatory and technical advice, support and expertise to the Executive Board as required and keep the company up to date regarding new regulations or certification changes in MDs, IVDs, Cosmetics, PPE & Pharmaceutical regulations; Participate in client meetings and tenders; Maintain and submit product dossiers to NB and Regulators to distribute MDs, IVDs, cosmetics, and Biocide products in other markets; Manage registration with the MOH in other countries; Ensure Pasante and its products are compliant with SEDEX, c-GMP, GDP, ISO 13485, UK MDR, EU MDR, EU IVDR, Cosmetics regulation, REACH, CLP, BIOCIDES, US FDA, quality requirements, specific country regulation and marketing authorisations; Lead Auditor, Trainer & programme Manager: Lead internal audits and supplier audits, generate reports, control audit programmes. Give internal auditor training courses to other employees. Review other internal lead auditor competencies and performance; R&D Advisor: Work closely with Manufacturers, third party lab and regulators for the research, design and development of medical devices and make them available in the market as well as work with Companies’ group team to improve manufacturing, operations and testing processes;
-
-
-
-
Quality Manager
-
May 2008 - Jan 2017
QMS RP: Manage ISO 9001, ISO 22716, ISO31000, HACCP, BRC, ECOCERT, Cruelty Free, SEDEX, GS1 & ISO 13485 certifications and licenses. Including but not limited to control of documents, control of customer complaints, plan management review, change control, generate cleanliness methods, control of risk management, review of suppliers performance, control of calibration, review of labelling, control of MSDS, manage toxicology assessments, control of non-conforming product, create COA, draft quality reports, control of hazardous material, support production trials, perform lab tests and trials; R&D Manager: Work closely with Manufacturers, third party lab and regulators for the research, design and development of MDs, Cosmetics, Household, Chemicals and Toiletries products, work with other departments to improve manufacturing, operations and testing processes; PRRC: Provide full regulatory and technical support to the Directors as required and keep the company up to date regarding new or changes in regulations related to other markets applicable to MDs, Chemicals, Food Packaging, Cosmetics, Household and Toiletries products; Participate in client meetings; Ensure AE Adams and its products are compliant with quality requirements, marketing authorisations, regulations and international Standards; Manage Cosmetics, Households, Toiletries, Medical Devices, and Biocide product dossiers and submit product dossiers to regulators as required; Dept. and Team Manager: Manage dept. budgets and resources; Manage a team reporting directly to me; Manage QA, QC, Lab. and Technical Dept.; Provide any training needed to personnel; Manage and liaise with relevant service providers; Lead Auditor, Trainer & programme Manager: Lead internal audits and supplier audits, generate reports, maintain and control audit programmes. Give internal auditor training courses to other employees. Review other internal lead auditor competencies and performance.
-
-
-
Barfoot of Botley LTD
-
United Kingdom
-
Food and Beverage Manufacturing
-
100 - 200 Employee
-
Production Line Supervisor
-
Apr 2008 - Jun 2008
To execute different activities related to production line operations, monitoring product waste, operating wrapper machine and a hi-tech robot used to pack cobs and cobettes and changing parts as needed, review the finished goods and its packaging methods to assure they meet the standards previously established for them, detect and solve (if it is possible) any issue regarding the quality of the product and the machine performance. To execute different activities related to production line operations, monitoring product waste, operating wrapper machine and a hi-tech robot used to pack cobs and cobettes and changing parts as needed, review the finished goods and its packaging methods to assure they meet the standards previously established for them, detect and solve (if it is possible) any issue regarding the quality of the product and the machine performance.
-
-
-
-
Quality Assurance Technician
-
Apr 2006 - Dec 2007
Support and assist production line managers and line leaders with online quality issues and decision making.Maintain and improve online inspection techniques and quality related production processes.Identify and analyse issues and offer recommendations / options to resolve quality and GMP problems.Review standard operating procedures, standard control method and equipment operating procedures.Plan weekly meetings with the Night Shift Team Leaders Support and assist production line managers and line leaders with online quality issues and decision making.Maintain and improve online inspection techniques and quality related production processes.Identify and analyse issues and offer recommendations / options to resolve quality and GMP problems.Review standard operating procedures, standard control method and equipment operating procedures.Plan weekly meetings with the Night Shift Team Leaders
-
-
-
-
Quality Manager
-
Aug 2003 - Mar 2006
QMS Responsible Person: Design and implement a quality management system (QMS), control of documents, Implement quality management system compliant with ISO 9001; generate AutoCAD drawings, GMP, Health & Safety system. Software Developer & Software Validator: Support the IT department in the modification and creation of personalised software applications to our clients using off the shelf Microsoft softwares, perform software validation, generate reports and control software validation processes.Department and Team Manager: Manage departmental budgets and resources; Manage a team of Seven reporting directly to me; Manage Quality, Technical, Health & Safety Department; Provide any training needed to personnel; Manage and liaise with relevant service providers;
-
-
Education
-
2003 - 2006
Universidad Católica Andrés Bello, Caracas – Venezuela
Master Degree in Quality Management Systems, Quality Control Technology/Technician -
1999 - 2003
Universidad Santa Maria, Caracas – Venezuela
Engineer's degree, Industrial Engineering -
1997 - 1999
IUTIRLA
Associate’s Degree, Chemistry -
1993 - 1997
Unidad Educativa Caurimare Uno, Caracas – Venezuela
Bachiller en Ciencias, Computer Science
Community
