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EU Post Market Surveillance Specialist

Hybrid in Madrid·Full-time·Added 8 days ago

Intuitive Surgical

12 open roles

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Overview

Job details

Full-time hours
Per the ad.
Hybrid
Office and home days — the ad has the split.

Requirements

Have the right to work in Spain
Intuitive Surgical doesn't mention sponsorship in the ad.
Speak fluent Spanish
Listed as a requirement in the ad.
Work in English
English is required, per the ad.
Be near Madrid, Spain (Hybrid) for hybrid days
No relocation package mentioned.
University degree
“A Bachelor’s degree or Swiss CFC (Health sciences preferred).” — per the ad.

Requirements

What we're looking for

Knowledge / understanding of the European Medical Device Directive 93/43/EEC and MEDDEV 2.12-1.
Understanding of quality records requirements and how they apply to complaint files and post market surveillance reports.
A Bachelor’s degree or Swiss CFC (Health sciences preferred).
6 months – 2 years of experience in complaint handling for medical devices.
Ability to handle multiple tasks, to prioritize and schedule work to meet business needs.
Demonstrate organizational and planning skills, including action oriented; focus urgency and driving for results.
Demonstrate good communication skills, over the phone, in person and in writing.
Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
Ability to guide customers in providing key relevant data for case management.
Orientation for work result details, with emphasis on accuracy and completeness.
Fluent in written and spoken English, Spanish and Portuguese.
General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).

Nice to have

US FDA 21 CFR 803/806/820 and EU Medical Device Regulation (2017/745/EU) basic knowledge would be a plus.
Experience with software such as TrackWise, ERP / CRM (eg. SAP) or Salesforce is a plus.

The role

The Post Market Surveillance Specialist supports the Regulatory Department by reviewing, evaluating, and performing follow up activities on all product complaints, determining if they require vigilance reporting and identifying supporting data.

What you'll do

Evaluates incoming complaint information and maintains the records in the electronic database as per company procedures and processes. Works closely with Customer Service to support the product return process as it relates to complaints.
Processes, records, and closes complaint-handling activities in a timely manner.
Conducts follow-up investigations with internal resources, field personnel and/or customer as appropriate to gather additional information for reported events and assist in data collection for trending purposes.
Determines reportability of complaints per regulatory reporting requirements.
Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team in US and European customers, including distributors.
Evaluates and reports device malfunctions involving company products to the European regulatory agencies.
Collect, trend, and escalate data related to Post Market Surveillance.
Assists and supports other employees, teams, and field personnel as necessary.
Other regulatory tasks and projects may be assigned as necessary.

About Intuitive Surgical

Intuitive Surgical is a global leader in minimally invasive care, best known for its da Vinci surgical systems that combine advanced robotic technology with precision instruments for a wide range of surgical procedures. The company designs, manufactures, and markets its robotic platforms and accompanying instruments, with a strong focus on improving patient outcomes and expanding access to minimally invasive surgery worldwide. With a multi-billion dollar revenue base and a workforce of over 10,000 employees, it operates across the Americas, Europe, and Asia, and continues to invest heavily in R&D and clinical evidence generation.

In Spain, Intuitive Surgical has a growing presence, with a commercial and clinical team based in Madrid and Barcelona supporting the adoption of da Vinci systems across the country. The company is known for a collaborative, engineering-driven culture that values clinical excellence and customer success, making it an attractive employer for international professionals with backgrounds in engineering, clinical support, and healthcare management. They offer a global career framework, which can be appealing for relocators, and frequently hire for roles that require Spanish and English language skills.

Industry: Medical Devices
Founded: 1995
Employees: 10,000+
Headquarters: Sunnyvale, USA
In Spain: Madrid, Barcelona
Website: intuitive.com

Good to know if you are moving

Offers a structured global career framework, which can facilitate internal transfers for international professionals.
Roles in Spain often require a mix of Spanish and English, making it accessible for international candidates.
The company values clinical and technical expertise, so international hires with medical or engineering backgrounds are highly sought after.
Positions in Spain are typically based in Barcelona or Madrid, with a hybrid work model common in corporate functions.
Intuitive Surgical provides a competitive relocation package for senior roles, including visa sponsorship in some cases.

In their own words

About the company & team

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.

Additional information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

All open roles at Intuitive Surgical