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Regulatory Affairs Specialist – Medical Devices (SaMD)

UpHill -
1990 Lisboa

Candidate-se agora

Detalhes da oferta

Período Integral

Qualificações

Graduação

Descrição completa da oferta

Location: Lisbon, Portugal (Hybrid options available)

About UpHill

At UpHill, we’re on a mission to revolutionize healthcare. By developing best-practice clinical pathways and care orchestration software, we help healthcare providers and life sciences companies across Europe streamline their processes, eliminate inefficiencies, and increase care coordination, which results in improve outcomes for patient — all while creating more capacity for health systems and enabling high quality healthcare healthcare to be delivered more cost effectively.

We’re not just another healthtech company; we have built the most compliance-ready care orchestration solution in Europe. We’re a team of innovators who push boundaries, take ownership, and strive for excellence. If you’re excited about making a real impact, growing alongside passionate colleagues, and tackling meaningful challenges, you just might be an Uphiller .

Today, we are looking for a Regulatory Affairs Specialist to build, own and operate our regulatory and quality framework.

What you will do

Own the regulatory system

Build, maintain and scale our regulatory and quality framework
Ensure compliance with:
- EU MDR (Medical Device Regulation)
- UKCA (United Kingdom Conformity Assessed marking)
- FDA (Food and Drug Administration, US) requirements for SaMD
Act as PRRC (Person Responsible for Regulatory Compliance) or prepare to formally assume this role
Own and maintain high quality technical files and documentation
Be the main point of contact with NB (Notified Body) and auditors

Run the Quality Management System

Design, operate and continuously improve the QMS (Quality Management System) under ISO 13485 (Medical Device Quality Management)
Plan and run internal audits
Prepare and lead external audits
Manage Corrective and Preventive Actions

Work inside the product team

Work daily with:
- Engineering (SDLC – Software Development Life Cycle, validation, traceability)
- Product and clinical teams
- Customer-facing teams
Translate regulatory requirements into practical product and process requirements
Create and deliver training and guidance for teams

Security & data

Support compliance related to ISO 27001 (Information Security Management Systems), cybersecurity and data protection for medical software

Who we are looking for

We are looking for someone who has already worked inside a medical device manufacturer , ideally in software or digital health , and who is comfortable building things from scratch.

Required

3+ years of experience in Regulatory Affairs, Quality or Compliance in a medical device company
Practical experience with:
- EU MDR (Medical Device Regulation)
- ISO 13485
- Technical documentation and audits
Eligibility (or a clear path) to act as PRRC (Person Responsible for Regulatory Compliance)
Experience working with NBs (Notified Bodies)
Comfortable working with engineers and product teams

Nice to have

Experience with SaMD (Software as a Medical Device)
Exposure to FDA (US) and UKCA
Knowledge of ISO 27001 and medical software cybersecurity

What You’ll Get

Be part of a mission-driven team shaping the future of healthcare

Competitive salary

Flexible work options

Comprehensive health insurance

Top-tier equipment – new PC plus budget for peripherals

A no-BS culture built on trust, impact, and collaboration

Ready to support the transformation of healthcare with us?
Apply now and become an Uphiller!

Candidate-se agora

Refine sua pesquisa

regulatory specialist vagas para: oeiras

Regulatory Affairs Specialist – Medical Devices (SaMD)

Credit Risk Regulatory Reporting Specialist

Cell and Organoid Culture Research Technician (Botton-Champalimaud Pancreatic Cancer Centre)

Analyst in UK Health Technology Assessment Strategy and Implementation - Portugal (Hybrid/Home-based)

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