Mariana Neto Costa
Regulatory Affairs Expert | Quality Responsible | Projects Manager
Aveiro
Summary
Experienced Regulatory Affairs Specialist and Project Manager with a strong background in CE Marking Compliance, Medical Device Certification, and EU-funded Innovation Project Management. Proven expertise in ISO 13485, ISO 9001, ISO 14971, Quality Management Systems, and Regulatory frameworks, combined with a passion for healthcare innovation and quality.
Overview
14
14
years of professional experience
4
4
years of post-secondary education
11
11
Certifications
3
3
Languages
Work History
Founder/Self-Employed – Quality & Regulatory Affairs Consultant/Manager
Medicompliance Lda.
01.2023 - Current
- Provide consultancy for CE marking compliance in e-health medical devices
- Support clients in navigating complex regulatory frameworks
Quality Unit Collaborator & Project Manager @ Rectory
University of Aveiro
01.2017 - Current
- Oversee customization and management of digital platforms for alumni relations
- Manage IT and Innovation Projects funded under national funding schemes
Quality Manager / Regulatory Affairs Specialist & R&I Projects Manager
SWORD Health S.A.
01.2015 - 01.2017
- Regulatory Affairs Specialist (CE marking and FDA approval for Medical Devices)
- Quality System Manager (QMS according to ISO 13485 and ISO 9001)
- Direction and Management of Research & Innovation Projects (Horizon 2020 and Portugal 2020 grants)
- AGILE and Scrum Methodologies in Project Management
Regulatory Affairs Specialist & R&I Projects Manager
Exatronic – Engenharia Electrónica, Lda.
01.2011 - 01.2013
- Management of R&D projects funded by national grants
- Contributor to the ISO 13485/ISO 9001 Quality Management System
Education
CQI IRCA Certified QMS ISO13485 Lead Auditor PR369 - Certified Medical Devices - QMS ISO 13485:2016
British Standards Institution (BSI)
UK 01.2025 - 01.2025
Postgraduate Master’s in Quality Management - ISO 9001 Internal Auditor, Quality Management System
SGS Porto, Portugal
10.2015 - 01.2016
Master of Science - Biomedical Engineering, Specialization on Medical Instrumentation and Biomaterials
University of Coimbra
Coimbra 09.2007 - 06.2011
Skills
Regulatory Affairs & Compliance (EU MDR 2017/745 & FDA)
undefinedCertification
48 Hours, Business English, University of Aveiro
Running and sewing
Long-distance running and creative sewing projects.
Timeline
CQI IRCA Certified QMS ISO13485 Lead Auditor PR369 - Certified Medical Devices - QMS ISO 13485:2016
British Standards Institution (BSI)
01.2025 - 01.2025
32 Hours, BSI CQI and IRCA Certified Medical Devices - Quality Management Systems Auditor/Lead Auditor ISO 13485:2016, PR369
01-2025
90 Hours, Trainer Training Course – IEFP (Portuguese Institute for Employment and Vocational Training)
11-2024
21 Hours, Advanced Excel, University of Aveiro
10-2023
Founder/Self-Employed – Quality & Regulatory Affairs Consultant/Manager
Medicompliance Lda.
01.2023 - Current
Quality Unit Collaborator & Project Manager @ Rectory
University of Aveiro
01.2017 - Current
6 Hours, Good Clinical Practices, CRA Scope International AG, Portugal
02-2016
104 Hours, Postgraduate Master’s in Quality Management – ISO 9001 Internal Auditor, Quality Management System, SGS Porto, Portugal
01-2016
32 Hours, ISO 9001 Internal Auditor, SGS Porto, Portugal
01-2016
36 Hours, ISO 9001:2015 Quality Management System, SGS Porto, Portugal
01-2016
Postgraduate Master’s in Quality Management - ISO 9001 Internal Auditor, Quality Management System
SGS Porto, Portugal
10.2015 - 01.2016
Quality Manager / Regulatory Affairs Specialist & R&I Projects Manager
SWORD Health S.A.
01.2015 - 01.2017
48 Hours, Business English, University of Aveiro
09-2012
Regulatory Affairs Specialist & R&I Projects Manager
Exatronic – Engenharia Electrónica, Lda.
01.2011 - 01.2013
Master of Science - Biomedical Engineering, Specialization on Medical Instrumentation and Biomaterials
University of Coimbra
09.2007 - 06.2011
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