CrawlJobs Logo
Gipo Logo Gipo · IT - Administration

Senior Healthcare Regulatory Specialist (SaMD)

Spain, Barcelona · Job Posted January 29, 2026
Apply Position
Job Link Share

Job Description

The Risk & Compliance team ensures Docplanner meets regulatory requirements while supporting safe, scalable, and innovative healthcare solutions. As our products increasingly transition into medical device territory, regulatory compliance is a core enabler of our growth, trust and ability to operate globally. We are hiring a Senior Healthcare Regulatory Specialist (SaMD) to join our global team. In this role, you will act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR), partnering closely with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams to ensure our Software as a Medical Device (SaMD) products meet regulatory requirements across Europe. You will play a key role in enabling Docplanner to operate safely, compliantly and at scale in an increasingly regulated digital healthcare environment.

Job Responsibility

  • EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access
  • Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance
  • Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
  • Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers
  • Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry

Requirements

  • Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context
  • Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks
  • Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience
  • Experience with EUDAMED, CAPA systems, and post-market surveillance tools
  • Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders
  • Strong communication skills with both internal teams and external regulatory authorities
  • Fluent in English

Nice to have

  • Knowledge of the EU AI Act
  • Familiarity with Agile / software development environments
  • Spanish or other EU languages are a plus

What we offer

  • Healthcare insurance
  • Wellness that works for you – from gym memberships to mental health support
  • Time off that counts – vacation, birthday, or just a day to recharge
  • ESOP (Employee Share Option Plan) after 6 months
  • Local Perks – meal vouchers (ticket restaurant), transport allowances, or extended parental leave
  • Career Growth – chances to learn, develop, and explore new paths
  • A Truly Global Team – Work with talented people from all over the world in a diverse and inclusive environment
  • Flexibility That Works for You – Remote work and flexible hours
Gipo - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Healthcare Regulatory Specialist (SaMD)

8 matching positions

Senior Healthcare Regulatory Specialist (saMD)

The Risk & Compliance team ensures Docplanner meets regulatory requirements whil...
Location
Location
Spain , Barcelona
Salary
Salary:
Not provided
docplanner.com Logo
DocPlanner GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context
  • Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks
  • Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience
  • Experience with EUDAMED, CAPA systems, and post-market surveillance tools
  • Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders
  • Strong communication skills with both internal teams and external regulatory authorities
  • Fluent in English
  • Spanish or other EU languages are a plus
Job Responsibility
Job Responsibility
  • EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access
  • Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance
  • Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
  • Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers
  • Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry
What we offer
What we offer
  • Healthcare insurance
  • Wellness that works for you – from gym memberships to mental health support
  • Time off that counts – whether it’s a vacation, your birthday, or just a day to recharge
  • ESOP (Employee Share Option Plan) after 6 months
  • Local Perks – Depending on your location, you will be entitled to local benefits like meal vouchers (ticket restaurant), transport allowances, or extended parental leave
  • Career Growth – lots of chances to learn, develop, and explore new paths
  • A Truly Global Team – Work with talented people from all over the world
  • Flexibility That Works for You – Remote work and flexible hours
  • Fulltime
Read More
Arrow Right
New

Pediatric Caregiver

Join Our Team as a Pediatric Caregiver! *Earn $14.75/hr + Paid Training Provided...
Location
Location
United States , Factoryville
Salary
Salary:
14.75 USD / Hour
caregiversamerica.com Logo
CareGivers America
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Provide 1:1 supervision and support to children in a safe, in-home setting
  • Assist with daily living skills, including hygiene, meals, and routine care as needed
  • Implement and support Individualized Education Programs (IEPs) and behavior support plans (BIPs)
  • Facilitate structured, age-appropriate activities that promote skill development
  • Support positive behavior strategies and maintain a consistent, safe environment
Job Responsibility
Job Responsibility
  • Provide 1:1 supervision and support to children in a safe, in-home pediatric setting
  • Assist children with daily living skills, including hygiene, meals, and routine care as needed
  • Implement Individualized Education Programs (IEPs) and behavior support plans (BIPs) for children as directed
  • Facilitate structured, age-appropriate activities that support children’s development and engagement
  • Promote positive behavior strategies and maintain a safe, consistent environment for children
What we offer
What we offer
  • Paid training & certification
  • Flexible schedules (full-time, part-time, and weekend shifts)
  • Medical, dental & vision insurance
  • Paid time off + 401(k)
  • Employee discounts & support programs
  • Opportunities for growth and advancement
  • Parttime
Read More
Arrow Right
New

Ai Software Engineer LLMs, RAG & Agentic AI

We are looking for an experienced Software Engineer to join a team developing th...
Location
Location
Belgium , Brussels
Salary
Salary:
598.00 - 700.00 EUR / Day
myn.co.uk Logo
Myn
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years' experience in Software Engineering (Backend or Full-Stack)
  • 1-2+ years' experience building applications using LLMs or Generative AI
  • Strong Python development skills
  • Hands-on experience with RAG, embeddings, vector databases, and retrieval optimisation
  • Experience with MCP, A2A, tool calling, or multi-agent architectures
  • Knowledge of cloud-native application development
  • Experience with APIs, integrations, CI/CD, testing, monitoring, and observability
  • Understanding of AI evaluation, quality metrics, and model performance
  • Security-conscious approach to handling business-critical data
  • Fluent English plus French or Dutch
Job Responsibility
Job Responsibility
  • Build AI-powered applications and intelligent workflows
  • Design retrieval and orchestration pipelines
  • Improve reliability, performance, and quality of AI solutions
  • Collaborate with engineers, product teams, and business stakeholders
  • Help shape best practices for enterprise AI development
  • Fulltime
Read More
Arrow Right
New

Clinical Pdn 1:1 Hawley Rn/Lpn

Location
Location
United States , Hawley
Salary
Salary:
28.00 - 34.00 USD / Hour
caregiversamerica.com Logo
CareGivers America
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Active RN or LPN license (state-specific)
  • Pediatric experience preferred, not required
  • New graduates welcome
  • CPR/BLS certification (or willingness to obtain)
  • Comfortable providing care for children with developmental and complex medical needs
  • Dependable, patient, and attentive bedside manner
Job Responsibility
Job Responsibility
  • Provide one-on-one skilled nursing care in a home setting
  • Monitor the child's health, safety, and overall condition
  • Administer medications and perform routine treatments
  • Provide seizure awareness and response (training available if needed)
  • Assist with mobility, positioning, and daily care needs
  • Complete clinical documentation and progress notes
  • Communicate changes, concerns, and updates with parents and care team
  • Support individualized care planning and ongoing updates (as applicable in home care model)
  • Offer comfort, engagement, and emotional reassurance throughout care
What we offer
What we offer
  • Flexible scheduling options
  • Medical, dental & vision insurance
  • Paid time off (PTO)
  • 401(k) with company match
  • Employee Assistance Program (EAP)
  • Employee discounts (retail, travel, dining, and more)
  • Career growth opportunities in home care nursing
  • Parttime
Read More
Arrow Right
New

Legal Operations & Legal Tech Lead

Location
Location
United States of America
Salary
Salary:
Not provided
mews.com Logo
Mews
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong experience in legal operations, legal transformation, legal programme management or a comparable enablement role in a tech, SaaS or fintech environment
  • A clear track record of implementing better tooling, workflows and service models rather than simply administering what already exists
  • Strong legal tech capability, with evidence of evaluating, implementing or scaling tools that changed how work gets done
  • Meaningful experience with CLM implementation, optimisation or ownership, ideally in a scaling in-house environment
  • Experience designing or improving processes that work across multiple jurisdictions and stakeholder groups
  • Hands-on experience applying AI to workflow design, knowledge management, documentation, reporting or service delivery
  • Strong judgement on where automation helps, where human review remains critical and how to build safe adoption habits
  • A practical, builder-style mindset with high ownership and a bias to execution
  • Strong stakeholder skills and the ability to work effectively with lawyers, operators, finance partners and technical teams
  • Comfort in ambiguous, under-structured environments where priorities need to be shaped, not just received
Job Responsibility
Job Responsibility
  • Redesign legal workflows, intake, triage, prioritisation and routing so the team can operate more effectively at scale
  • Own and improve legal tooling, knowledge systems, document workflows and self-service enablement across the function
  • Evaluate, implement or optimise CLM and related legal tech, including AI, billing and orchestration tools, to improve speed, consistency and visibility
  • Identify and implement practical AI use cases across legal work, including drafting support, knowledge access, contract workflows, intake, reporting and process design
  • Partner with the Chief Legal Officer and legal pillar leads on how work should be structured and where it should sit across lawyers, contracts managers, AI-enabled workflows and outside counsel
  • Build dashboards, reporting and planning rhythms for legal demand, service levels, spend, risk areas and team priorities
  • Own budgets and forecasting for the function, and sharpen outside counsel administration, invoice handling and spend optimisation
  • Create scalable templates, playbooks, training materials and working norms for the wider business
  • Lead or support transformation projects across Legal, Compliance, Product, Procurement, People and Commercial teams
  • Bring order, pace and measurable execution to special projects owned by the CLO organisation
What we offer
What we offer
  • Unlimited paid holiday
  • Participation in our company share program
  • Paid parental leave (6 months fully paid for primary caregivers, 2 months for secondary, available after one year of service)
  • An annual Learning budget of €300 (and more for high performers) to support your development
  • Monthly EDGE time to Explore, Develop, Grow, and Elevate yourself
  • A work from anywhere policy with flexibility to work abroad for a few weeks each year
  • Relocation options, available after one year
  • Flexible, hybrid working options
  • A home office setup budget to make your workspace your own and a monthly work-from-home allowance
  • Claude tokens, so you can automate workflows and build smarter, more efficient ways of working
Read More
Arrow Right
New

Caregiver

Join Our Team as a Caregiver! *Earn Up to $14.25hr + Extra Cash through our Care...
Location
Location
United States , Rome
Salary
Salary:
14.25 USD / Hour
caregiversamerica.com Logo
CareGivers America
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Must be willing to work in Rome, Ulster or Warren Center
  • Availability to work weekdays, day shift
  • Reliable transportation required
Job Responsibility
Job Responsibility
  • Bring comfort and companionship to clients in their homes
  • Help with daily care like bathing, dressing, toileting, and meals
  • Keep living spaces clean, safe, and welcoming
  • Offer medication reminders and support healthy routines
  • Communicate concerns and escalate safety issues as needed
What we offer
What we offer
  • Paid Orientation
  • Weekly Pay
  • Flexible Schedules
  • Earn up to $375 for referring a friend
  • Caregiver Rewards Program
  • Premium Holiday Pay
  • Paid Time Off + Benefits (medical, dental, vision, retirement)
  • Free Employee Assistance Program
  • Discount Perks
  • Career Growth
Read More
Arrow Right
New

Senior Product & Regulatory Counsel

Mews is looking for a senior product counsel to serve as a trusted legal partner...
Location
Location
Salary
Salary:
Not provided
mews.com Logo
Mews
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Significant in-house legal experience in technology, SaaS, fintech or another fast-moving, multi-geography environment
  • Strong evidence of working closely with product teams rather than reviewing work at the end of the process
  • Fintech and regulatory exposure, ideally in payments, embedded finance, e-money or another licensed setting
  • Working knowledge of AML/BSA, KYC, KYB and broader fintech regulatory issues such as money transmission and lending
  • Strong commercial judgement and a track record of balancing legal risk with business outcomes
  • A practical, hands-on builder mentality with examples of what you’ve improved, created or operationalised yourself
  • Comfort operating in ambiguity and helping teams move quickly with good judgement
  • Strong stakeholder skills and credibility with senior leaders, while still being happy to work at operating-detail level
Job Responsibility
Job Responsibility
  • Partner directly with Product and Engineering teams on new products, features, launches and changes
  • Act as a true product counsel and product champion, helping teams spot and triage issues throughout the design and release lifecycle
  • Advise on product, fintech, payments and commercial legal questions across Mews’ SaaS and financial services environment
  • Help teams navigate legal, regulatory and commercial trade-offs early and pragmatically
  • Draft, review and negotiate a broad mix of commercial, product, partner and regulated-services agreements
  • Support licensed and regulated products across areas such as payments, embedded finance, money transmission, lending, partner bank models and cross-border expansion
  • Apply working knowledge of financial crime topics such as AML/BSA, KYC and KYB to product and licensing decisions
  • Help the business navigate regulatory audits, supervisory expectations and the realities of operating regulated products at scale
  • Build practical guidance, playbooks, templates and ways of working that help teams move faster without creating unnecessary risk
What we offer
What we offer
  • Unlimited paid holiday
  • Participation in our company share program
  • Paid parental leave (6 months fully paid for primary caregivers, 2 months for secondary, available after one year of service)
  • An annual Learning budget of €300 (and more for high performers)
  • Monthly 'EDGE' time to Explore, Develop, Grow, and Elevate yourself
  • A work from anywhere policy with flexibility to work abroad for a few weeks each year
  • Relocation options, available after one year
  • Flexible, hybrid working options
  • A home office setup budget
  • Monthly work-from-home allowance
  • Fulltime
Read More
Arrow Right
New

Clinical: PDN 1:1 - Union County LPN

CareGivers America, a Modivcare Personal Care Service, is looking for an RN/LPN ...
Location
Location
United States , Clarks Summit
Salary
Salary:
Not provided
caregiversamerica.com Logo
CareGivers America
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • RN/LPN with at least 1 year of experience preferred
  • 1 year of Home Care experience preferred
  • New grads welcomed
Job Responsibility
Job Responsibility
  • Conduct initial home visits to assess patient needs
  • Conduct starts of care, resumption of care, assessments, and supervisory visits/re-visits
  • Develop Plan of Care for each patient and continuously monitor need to revise or reevaluate based on patient's progress
  • Document daily clinical notes and progress updates on patient's clinical record
  • Communicate with patient’s physician and other healthcare professionals to ensure delivery of appropriate patient care
  • Provide skilled nursing care as necessary
What we offer
What we offer
  • Medical, Dental & Vision Insurance
  • 401(k) with a 6% match
  • Paid Time Off
  • Employee Assistance Program
  • Employee Discounts
  • Voluntary Term Life and AD&D Insurance
  • Legal Services Insurance
  • Short-Term and Long-Term Disability
  • Accident, Critical Illness & Hospital Indemnity Insurance
Read More
Arrow Right