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88,000+ live jobsSenior Regulatory Affairs & Quality Consultant (Medical Devices & IVD)
Hybrid in Barcelona·Full-time·Added today (last checked 9 Nov)
16 open roles
Our summary
- Work mode
- Hybrid, Barcelona
- Contract
- Permanent, full-time hours
- Spanish
- Fluent
- English
- Required
- Experience
- 7+ years
- Education
- University degree
- Benefits
- Private health insurance, flexible pay plan, meal vouchers, gym access
Visa options
The ad doesn’t mention sponsorship
Not a refusal, but not a yes. Worth asking in your first message.
Skills
This job advert was originally written in Spanish.
Requirements
What we're looking for
Degree or Bachelor's in Health Sciences, Pharmacy, Biotechnology, Biology, Chemistry, or Biomedical Engineering.
Between 7 and 10 years of experience in Regulatory Affairs, Quality Assurance, R&D, or specialized consulting in Medical Devices and IVD.
Demonstrable experience with Class IIa, IIb, or III medical devices.
Experience in the preparation and defense of technical documentation before Notified Bodies.
Experience in internal and external audits under ISO 13485.
Deep knowledge of
MDR (EU 2017/745)
IVDR (EU 2017/746)
ISO 13485
ISO 14971
MDCG Guides
Knowledge of international registrations such as FDA 510(k), PMA, or LATAM markets.
Spanish and English are essential.
Advanced English (C1 or higher), both written and spoken.
Demonstrable ability to draft regulatory and technical documentation in English and participate in international audits, inspections, and meetings.
Nice to have
PhD or specialized Master's in Regulatory Affairs, Medical Devices, or biomedical areas.
Experience with high-risk products, biomaterials, injectables, or IVD systems.
Knowledge of IEC 62304, IEC 82304, and cybersecurity applied to medical devices.
Experience in Software as a Medical Device (SaMD).
Pay & benefits
What you'll get
Flexible compensation plan (tax-free) where we provide you with medical insurance, public transport tickets, and childcare vouchers.
Meal vouchers.
Discounts on gym network: WellHub
Training catalog.
Referral Program
Our goal is your well-being in every sense!
The role
At Ambit Iberia, we continue to grow within our Consulting division specializing in Pharma & Biotech. We are looking for a Senior Regulatory Affairs & Quality Consultant (Medical Devices & IVD) to lead high-impact projects in the medical device and in vitro diagnostic sector, collaborating with manufacturers, laboratories, and innovative companies internationally.
If you have a solid track record in Regulatory Affairs, Quality Assurance, and compliance for Medical Devices and IVD, and you want to participate in strategic projects with a high technical level, this opportunity is for you.
What you'll do
You will be responsible for leading regulatory and quality consulting projects, supporting clients in compliance with European and international requirements, as well as in the implementation and maintenance of quality management systems.
Lead the creation, updating, and remediation of technical files (Technical Files and Design History Files).
Prepare and justify compliance with MDR (EU 2017/745) and IVDR (EU 2017/746) requirements.
Develop traceability matrices and regulatory documentation.
Manage the defense of files before Notified Bodies.
Draft and update CER, PMS, PSUR, PMCF, and PMPF.
Analyze clinical and bibliographic data to demonstrate safety and efficacy.
Provide regulatory support throughout the entire product life cycle.
Design, implement, and maintain Quality Management Systems under ISO 13485.
Participate in internal, external, and supplier qualification audits.
Manage risk analysis according to ISO 14971 using FMEA, Ishikawa, and Fault Tree Analysis methodologies.
Manage CAPAs, deviations, and change control.
Advise on IQ, OQ, and PQ validations.
Provide support in the validation of analytical methods and manufacturing processes.
Participate in projects related to Software as a Medical Device (SaMD) and EUDAMED management.
Design and deliver specialized training in MDR, IVDR, PMS, risk management, and quality systems.
Act as a technical reference for clients and internal teams.
How you'll work
SCHEDULE 🕘:
Flexible schedule between 08:00 and 18:00.
Hybrid work model: 2 days on-site per week
CONDITIONS 🌱:
Permanent contract, full-time
Expected start date: December
About Ambit Iberia
Ambit Iberia is a specialized consultancy providing IT and engineering services to the pharmaceutical and life sciences sectors, with a strong focus on regulated environments. The company supports clients with digital transformation, data integrity, and compliance-driven projects, offering services such as system validation, MES engineering, cybersecurity, and cloud-based software development. Operating primarily in Spain and Portugal, Ambit Iberia positions itself as a niche partner for pharma companies seeking technical expertise in highly regulated settings.
With its main office in Barcelona, Ambit Iberia serves as the Spanish arm of a broader international group, delivering projects across Europe. The company's work culture emphasizes technical excellence and regulatory compliance, making it an attractive option for international professionals with backgrounds in pharma IT, validation, and engineering. Many roles are offered as fully remote or hybrid, allowing flexibility for candidates based in Spain or Portugal, and the company actively seeks talent with experience in GxP environments and modern cloud technologies.
- Industry
- Health
- Employees
- 160
- Headquarters
- Barcelona, Spain
- In Spain
- Barcelona
Good to know if you are moving
- Ambit Iberia offers fully remote positions for some roles, allowing flexibility for international professionals based in Spain or Portugal.
- The company specializes in the pharmaceutical sector, providing opportunities to work on regulated systems and compliance-driven projects.
- Barcelona, where Ambit Iberia is based, is a major European hub for life sciences and technology, offering a vibrant professional community.
- Roles often require expertise in GxP, MES, and cloud technologies, making it a good fit for specialists in pharma IT and engineering.
- The company's international group structure may offer opportunities for cross-border collaboration and career growth.
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