Open To Work
Verified
This profile is verified using an email address.
Carlos Magno Pinto
Lisbon
Work Preference
Summary
Highly accomplished Regulatory Affairs & Quality professional with over 20 years of international experience spanning medical devices, chemical compliance, food and feed additives, clinical research, and laboratory management. Proven track record as Person Responsible for Regulatory Compliance (PRRC) under EU MDR/IVDR, with hands-on expertise in CE Marking, FDA submissions, ISO 13485 QMS implementation, and post-market surveillance. Combines deep scientific knowledge (Molecular Biology & Biotechnology) with multilingual communication skills (6 languages) and a reputation for building regulatory strategy from the ground up.
Quality management professional with robust experience in driving process improvements and ensuring compliance with industry standards. Skilled in root cause analysis, auditing, and quality control methodologies. Strong focus on team collaboration and achieving results, adaptable to changing needs. Known for reliability, problem-solving abilities, and effective communication.
Quality management professional with history of driving process improvements and ensuring compliance with stringent quality standards. Proven ability to collaborate effectively with cross-functional teams and achieve significant results. Known for reliability and adaptability in dynamic environments, with strong skills in process optimization and quality assurance.
Overview
1
1
Certification
23
23
years of professional experience
Work History
Regulatory Affairs & Quality Manager
Ultra Controlo
Portugal
06.2024 - Current
- Responsible for regulatory compliance of medical devices (ULTRAVAC Medical Vacuum Systems, Class IIB) under MDD 93/42/EEC and EU MDR 2017/745.
- Maintaining and improving the ISO 13485 Quality Management System with zero major non-conformities in audits.
- Preparing and managing CE marking technical documentation, clinical evaluations, and post-market surveillance reports.
- Liaising with Notified Body SGS Belgium (NB 1639) and competent authorities for regulatory submissions.
- Driving regulatory strategy and ensuring continued compliance to facilitate business growth.
- Developed and implemented quality management systems to ensure compliance with industry standards.
- Conducted regular audits and inspections to identify areas for process improvement.
- Trained and mentored staff on quality control procedures and best practices.
- Collaborated with cross-functional teams to resolve quality-related issues promptly.
- Analyzed data trends to drive continuous improvement initiatives across operations.
- Established KPIs for measuring product quality and operational efficiency.
- Managed root cause analysis investigations, determining underlying issues in product failures and implementing corrective actions as necessary.
- Facilitated cross-functional team collaboration, ensuring seamless communication between departments regarding quality matters.
Consultant – Medical Devices Regulatory Affairs
Medical Devices
Netherlands (Remote)
- 01.2025
- Providing ongoing expert consultancy on EU MDR/IVDR compliance, technical documentation, and market access strategy.
- Supporting clients with Class I–III device classifications, risk management, and PMS activities.
- Ongoing until May
PRRC & Regulatory Affairs Manager
P4Q Health
Spain
04.2023 - 05.2024
- Served as PRRC for Class II & III medical devices and IVDs, ensuring full EU MDR and IVDR compliance.
- Led CE Marking processes for new products, achieving faster time-to-market.
- Spearheaded MDSAP certification and FDA 510(k) pre-submissions, expanding global market reach.
- Managed PMS activities including vigilance reporting, adverse event analysis, and PMCF planning.
- Developed and maintained ISO 13485 QMS; zero major non-conformities recorded during all audit cycles.
- Conducted regulatory intelligence on MDCG guidelines and MDR/IVDR transition updates.
- Ensured compliance with regulatory requirements for product submissions and approvals.
- Developed and maintained regulatory documentation, including protocols and reports.
- Collaborated with cross-functional teams to strategize on regulatory pathways.
- Reviewed labeling and promotional materials for compliance with regulations.
- Trained staff on regulatory processes and best practices to enhance team efficiency.
- Led initiatives to streamline submission processes, reducing turnaround times significantly.
Senior Regulatory Affairs Consultant & PRRC
MED-DI-DIA
Ireland
06.2022 - 04.2023
- Acted as PRRC across multiple clients, ensuring compliance with EU MDR 2017/745 and IVDR 2017/746.
- Led CE Mark and UK CA Mark submissions, managing Technical Documentation and Design Dossiers end-to-end.
- Served as EU Authorised Representative, liaising with Notified Bodies (BSI, T
- V) for conformity approvals.
- Implemented risk management (ISO 14971), clinical evaluations (CER/PER), and PMS frameworks for clients.
Regulatory Affairs, Compliance & Formulations Manager
NutriBio
Ireland
02.2020 - 05.2022
- Established a fully operational laboratory from inception, overseeing equipment installation and standard operating procedure development.
- Analyzed regulatory requirements and crafted strategies for feed additive products to facilitate entry into EU and global markets.
- Conducted regular audits and assessments to maintain compliance with health, safety, and environmental regulations.
- Developed and delivered comprehensive training programs to ensure adherence to regulatory procedures and quality standards.
- Developed and implemented operational processes to enhance efficiency across departments.
- Led cross-functional teams to strategize product development and launch initiatives.
- Streamlined supply chain management procedures, resulting in reduced lead times.
Technical & Quality Manager (Consultant)
Vitafor
Belgium
05.2019 - 09.2019
- Strengthened regulatory dossiers with scientific evidence, field trial information, and background documentation.
- Managed product registrations and prepared submissions for local authorities worldwide.
- Coordinated FDA registration and liaised with national, European, and international regulatory authorities.
- Reviewed supply chain contractual documents; built new laboratory and implemented GLP procedures.
Quality Improvement Leader / Technical Manager – Dental Implants
Argobau (Consultant)
Elvas, Portugal
02.2019 - 05.2019
- Ensured technical documentation compliance with MDD 93/42/EEC and MDR 2017/745.
- Performed conformity assessments for CE marking; compiled regulatory submissions to EU, FDA, and Health Canada.
- Interacted with authorities, notified bodies, and approving bodies; delivered regulatory training to the team.
- Streamlined project workflows, enhancing efficiency and reducing turnaround times.
Business Development & Technical Manager
Animalar-Rumenco
Portugal & Spain
09.2014 - 12.2018
- Managed European sales targets, quality budgets, and a team of regional quality employees.
- Advised on nutritional specifications (minerals, vitamins, microbiology) and set product guarantees for Regulatory.
- Led KPI communication, talent development, and cross-departmental goal-setting across the European region.
- Managed high-level NCR identification, CAPA execution, and regulatory affairs for animal feed products.
Business Development Manager & Technical Advisor (Consultant)
Silvateam – Feed Additives
Italy
01.2018 - 09.2018
- Created a pan-European distribution network for animal nutrition products across all livestock species.
- Provided regulatory advice on feed additive compliance, label translation, and product registrations.
- Managed B2B sales, CRM, direct farm contacts, and livestock performance trials; specialist in poultry nutrition.
Compliance & Regulatory Affairs Data Manager
LGC
02.2013 - 04.2014
- Created and maintained Safety Data Sheets (SDS), Certificates of Analysis (CofA), and regulatory documents.
- Ensured product compliance with EU and global chemical regulations: BPR, REACH, Detergents, CLP, GHS.
- Managed HRMC Labs Data to drive corrective and preventive actions from audit findings.
- Applied Six Sigma methodology; handled European pharmaceutical applications and customer regulatory enquiries.
Project Manager (3-month contract)
ICON Clinical Research
08.2012 - 10.2012
- Managed multilingual translation projects (Spanish, Portuguese, English, German, Dutch) for 60+ translators.
- Conducted in-house monitoring, ethics committee submissions, site start-ups, and QC review of SOPs and patient documents.
- Coordinated global eTMF Quality team activities across UK and USA operations.
Project Manager & European Microbiology Expert
JRC-IRMM (European Commission)
Geel, Belgium
07.2007 - 06.2009
- EU Reference Laboratory evaluator for EFSA and DGsanco applications for feed/food additive authorisation.
- Authored and compiled regulatory dossiers; acted as rapporteur under European legislation.
- Conducted scientific evaluation of analytical methods; audited laboratories and supported National Reference Laboratories.
- Chaired interdepartmental EURL training workshops; managed CIRCA database and served as EURL Webmaster.
Clinical Site Specialist
UBC Late Stage Group
London, UK
08.2007 - 05.2009
- Monitored clinical trial sites across multiple therapeutic areas (oncology, arthritis) ensuring protocol adherence.
- Managed electronic data capture, regulatory document collection, CRF quality control, and adverse event follow-up.
- Conducted training on protocol and study procedures; supported business development team activities.
Laboratory Technician
Corby Bottlers
UK
09.2005 - 05.2006
- Performed microbiology analysis, wet chemistry, spectrophotometry, density and shelf-life analysis.
- Implemented HACCP, conducted audits, managed CAPA, and created/improved SOPs.
Technical Support & Sales Adviser – Microbiology
VWR (ex-Merck)
UK
07.2005 - 03.2006
- Provided technical support and sales management for microbiology product lines.
- Handled customer enquiries (phone and email) in four languages; liaised with manufacturers.
Line Manager
Geo Adams & Sons
UK
10.2003 - 03.2004
- Managed a team of 45 multilingual workers across low-risk and high-risk food production areas.
- Responsible for quality assurance, team motivation, and translation of technical documents.
Education
PgDip in Clinical Research - Quantitative/Qualitative Research Analysis, EC Submissions, Good Clinical Practice, Ethics in Clinical Research, Observational Research, Statistics
Newcastle University
UK01-2013
BSc Molecular Biology and Biotechnology - Molecular Biology, Biochemistry, Microbiology, Biotechnology & Environmental Microbiology, Genetics & Gene Regulation, Protein Analysis & Purification, Human Metabolism, Statistics, Antimicrobial Agents
University of Hull
UK01-2003
Skills
- EU MDR 2017/745 & IVDR 2017/746
- FDA 510(k), PMA & Pre-submissions
- MDSAP Certification
- REACH, BPR, CLP, GHS, FIFRA
- GLP, GMP, GCP, ICH-GCP
- Microbiology & HPLC / Chromatography
- Regulatory Intelligence & Strategy
- PRRC (Person Resp for Reg Compliance)
- ISO 13485 QMS & Lead Auditing
- Clinical Evaluation Reports (CER/PER)
- Feed & Food Additives Reg Affairs
- CAPA & Non-Conformance Management
- Laboratory Setup & SOP Creation
- Training & Cross-functional Leadership
- CE Marking & UK CA Mark
- ISO 14971 Risk Management
- Post-Market Surveillance (PMS/PMCF)
- EFSA & DGsanco Dossier Management
- UDI / GUIDD Implementation
- Technical Documentation & IFU
- B2B Business Development
- Internal auditing
- Quality management systems
- Compliance monitoring
- Corrective actions
- Quality processes
- Regulatory compliance
- Document management
- SOP development
- Continuous improvement
- Quality planning
Certification
- PRRC – MDR/IVDR (EU 2017/745 & 746)
- ISO 13485 Lead Auditor & QMS Implementation
- ISO 14971 Risk Management
- Clinical Evaluation Reports (CER/PER)
- MDSAP & FDA 21 CFR 820
- GMP Diploma – Newcastle University (2011)
- GLP Diploma – Newcastle University (2011)
- ICH-GCP Diploma – Newcastle University (2011)
- ISO 9001 & ISO 17025
- ISO 10993-1 Biocompatibility
- ISO 13485 & CAPA Training
- Business Management Diploma (2001)
- ISO 9000 / HACCP Audit
- Six Sigma
- JRC TrainMic – Metrology in Chemistry
- EU Feed/Food Law (JRC-IRMM)
- Regulatory Affairs – Drugs & Food Supplements
- Bioanalytical Methods Validation
- EN 15038 / 15784–15789 (Translation Standards)
- Biosafety Training
- Sales & Business Management Diploma (1999)
LANGUAGES
Portuguese Native
English Bilingual (C2)
Spanish Fluent (C1)
German Conversational
Dutch Conversational
French Conversational
Italian Conversational
Timeline
Regulatory Affairs & Quality Manager
Ultra Controlo
06.2024 - Current
PRRC & Regulatory Affairs Manager
P4Q Health
04.2023 - 05.2024
Senior Regulatory Affairs Consultant & PRRC
MED-DI-DIA
06.2022 - 04.2023
Regulatory Affairs, Compliance & Formulations Manager
NutriBio
02.2020 - 05.2022
Technical & Quality Manager (Consultant)
Vitafor
05.2019 - 09.2019
Quality Improvement Leader / Technical Manager – Dental Implants
Argobau (Consultant)
02.2019 - 05.2019
Business Development Manager & Technical Advisor (Consultant)
Silvateam – Feed Additives
01.2018 - 09.2018
Business Development & Technical Manager
Animalar-Rumenco
09.2014 - 12.2018
Compliance & Regulatory Affairs Data Manager
LGC
02.2013 - 04.2014
Project Manager (3-month contract)
ICON Clinical Research
08.2012 - 10.2012
Clinical Site Specialist
UBC Late Stage Group
08.2007 - 05.2009
Project Manager & European Microbiology Expert
JRC-IRMM (European Commission)
07.2007 - 06.2009
Laboratory Technician
Corby Bottlers
09.2005 - 05.2006
Technical Support & Sales Adviser – Microbiology
VWR (ex-Merck)
07.2005 - 03.2006
Line Manager
Geo Adams & Sons
10.2003 - 03.2004
BSc Molecular Biology and Biotechnology - Molecular Biology, Biochemistry, Microbiology, Biotechnology & Environmental Microbiology, Genetics & Gene Regulation, Protein Analysis & Purification, Human Metabolism, Statistics, Antimicrobial Agents
University of Hull
Consultant – Medical Devices Regulatory Affairs
Medical Devices
- 01.2025
PgDip in Clinical Research - Quantitative/Qualitative Research Analysis, EC Submissions, Good Clinical Practice, Ethics in Clinical Research, Observational Research, Statistics
Newcastle University
ADDITIONAL INFORMATION
- Expert in EU and global regulatory compliance for medical devices (Class I–III, IVDs, SaMD), chemicals, and food/feed additives.
- Experienced with Notified Body audits (BSI, SGS), Competent Authority inspections, and CAPA management.
- Strong cross-functional collaboration with R&D, Manufacturing, Quality, and Commercial teams.
- Highly IT literate: Microsoft Office Suite, ERP systems, eTMF, SharePoint, regulatory databases, Web Manager.
- Available for consultancy, PRRC roles, and full-time positions across Europe and internationally.