Purpose:

Product Specialist of Cosmo Intelligent Medical Devices.

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Build and maintain strong relationships with existing customers by planning and organizing regular visits to ensure continuous support and identify new sales opportunities.
• Develop new business opportunities and convert them into long-term partnerships, contributing to sales success.
• Provide technical support and clinical training to customers on the effective use of medical devices, ensuring a high level of customer satisfaction.
• Coordinate and organize hands-on demonstrations, presentations, and educational programs for healthcare professionals, representing the company at congresses and symposiums.
• Actively collaborate with internal departments, including R&D, marketing, and quality assurance, to ensure effective product strategy alignment.

Qualification – Skills, and Abilities

• Bachelor’s degree in a scientific discipline, preferably Biomedical Engineering, Life Sciences, or a related field.
• At least 3 years of experience as a Product Specialist or similar role in the medical device industry.
• Strong knowledge of the medical device sector, including regulatory requirements and compliance standards.
• Excellent communication and presentation skills, with the ability to convey technical knowledge to non-technical audiences.
• Analytical skills to assess market data and develop effective sales strategies.
• Willingness to travel frequently to meet clients and attend industry events.
• Fluency in English, both written and spoken.
• Personal Attributes:
  • Customer-oriented mindset and ability to build long-term trusted relationships.
  • Proactive and problem-solving attitude, with the ability to work independently and within a team.
  • Flexibility and adaptability in a dynamic and evolving environment.
  • Strong motivation and results-driven approach, with excellent time management and prioritization skills.

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006

Purpose:

Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A. Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents. Cooperate with other departments to the creation and update of technical documentation needed according to country requirements. Assist external stakeholders in the regulatory process per country requirements.
• Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements.
• Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect.
• Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape.
• Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings.
• Promote the culture of compliance by proactively interacting with all departments and by provision of trainings.
• Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities.

Qualification – Skills, and Abilities

• Bachelor’s degree in engineering, science or related scientific discipline, or equivalent. Higher degree/PhD will be an advantage.
• Minimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry.
• English proficiency at professional level
• Professional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971.
• Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy.
• Personal Attributes:
  • Strong analytical skills with a detail-oriented approach.
  • Ability to work independently and collaboratively across multifunctional teams.
  • Highly dynamic and adaptable to a fast-moving and innovative environment.

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006

Purpose:

Senior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports. Review and provide input on mitigations, labeling and training materials, adverse events, complaints, incidents, and trends.
• Manage and document post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with safety data, trend analysis.
• Manage vigilance reporting to Competent Authorities and other stakeholders according to country requirements and assess failure investigations from the regulatory viewpoint.
• Work with customers/users to gather information/data to support investigations and complaints management.
• Monitor external sources/trends on emerging issues, including complaints, MDR trends, and regulatory trends, literature and scientific publications.
• Transfer the regulatory compliance aspects during the design and development stage of products and act as contact point across the company functional areas.
• Act as department representative during audits and other regulatory body interactions in the field of vigilance and post-market surveillance.
• Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect.
• Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape.
• Promote the culture of compliance by proactively interacting with all departments and by provision of trainings.
• Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities.

Qualification – Skills, and Abilities

• Bachelor’s degree in medicine, pharmacology, biomedical science or related scientific discipline, or equivalent. Higher degree/PhD will be an advantage.
• Minimum of 5 years of experience in the regulatory affairs field in medical device industry of which minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U.S and to MDD/MDR requirements in EU.
• English proficiency at professional level
• Deep knowledge and operative understanding of Reg. (EU) 2017/745 and MDCG documents, Title 21 CFR parts 800-898, and technical standards such as ISO 13485, ISO 14971, ISO/TR 20416, ISO 62304.
• Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy.
• Basic knowledge of Reg. (EU) 2024/1689.
• Personal Attributes:
  • Strong analytical skills with a detail-oriented approach.
  • Ability to work independently and collaboratively across multifunctional teams.
  • Highly dynamic and adaptable to a fast-moving and innovative environment.

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006

Purpose:

Mechanical Engineer of Cosmo Intelligent Medical Devices.

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Design of mechanical components in bent sheet metal and/or CNC-machined parts.
• Design of mechanical components made of plastic material to be produced using injection molding technology.
• Design of cooling systems for electronic systems.
• Definition and maintenance of BOM (Bill of Materials).
• Prototyping and testing.
• Interfacing with software, firmware, electronics, and quality departments during various development stages.
• Providing support for product documentation.

Qualification – Skills, and Abilities

• Degree in Mechanical Engineering.
• Excellent knowledge and use of 3D CAD design software, particularly SolidWorks.
• At least 3 years of experience in mechanical design of complete machines with electronic parts.
• Proficiency in written and spoken English.
• Experience in the medical device industry.
• Knowledge of IEC 60601-1 and IEC 60601-1-2 standards.
• Previous experience in “Design for Quality” methodology.
• Personal Attributes:
  • Ability to work under stress and tight deadlines.
  • Excellent interpersonal skills.
  • Teamwork orientation.
  • Problem-solving mindset.
  • Willingness for continuous learning.

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006

Purpose:

Lead the SaMD (Software as Medical Device) Team

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Lead the SW team:
  1. Create an inspiring team environment with an open communication culture
  2. Set clear team goals
  3. Motivate team members
  4. Oversee day-to-day operation
  5. Discover training needs and provide coaching
  6. Encourage creativity and risk-taking
• Design, develop and maintain SW as Medical Devices.
• Proactively collaborate with other teams (Electronics, AI, Mechanical, Quality)
• Create and iterate user needs, risk management, and product requirements while identifying plans for verification and validation
• Identify and mitigate project risks
• Interface with internal and external suppliers, manufacturers, and customers
• Work collaboratively with project teams and engineering skillsets through all stages of development

Qualification – Required Knowledge, Skills and Abilities

• Extensive experience in C++ and Python.
• In-depth knowledge of Linux/Yocto for operating system design.
• Experience with orchestration tools and technologies for designing and managing container-based applications.
• Excellent knowledge of Git and source code management tools.
• Ability to manage and coordinate software development teams.
• Skills in defining testing strategies, implementing test automation, and ensuring software quality.
• Nice to have:
  • Knowledge of Secure Boot and security techniques for embedded systems.
  • Understanding of cybersecurity, including best practices for data protection and security of embedded applications and devices.
  • Experience in full-stack web application development (both front-end and back-end).

Minimum Required Education and Experience

• Master Degree in Physics, Mathematics, Computer Science, or Software Engineering (PhD is a plus).
• At least 5 years of experience with C and C++ (mainly standard library), and a basic knowledge of Python and Bash. Experience with GPU programming (CUDA) is a plus
• Knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices
• Fluent English, written and spoken.
• Knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices is a plus

Physical Requirements

• Expected travel is 30%

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006

Purpose

Join the Quality Service Operations team to uphold the highest standards of quality and compliance in post-market support, ensuring exceptional service and reliability for life-saving medical devices.

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities

• Service Support:
  • Oversee all processes related to the collection and review of the service records.
  • Review the service activities related to medical device products and ensure the correctly storage of records
  • Ensure that all service activities comply with regulatory standards, quality control protocols, and company policies
  • Review the service manual and all documentation provided to external parties used to carry out service activities
• Equipment Management: manage the equipment calibration and control the calibration expirations.
• Non conformities management: open and manage the non conformities issued during the service process, correction and corrective action
• Complaint management: manage the complaint activities. Ensure that activities are correctly carried out and registered
• Problem Solving: support the Lead Service Engineer in the implementation of the corrective actions to minimize disruptions. Ensure that activities are correctly carried out and registered
• Training: ensure that the training and guidance to external parts are correctly registered
• Compliance: Support the Regulatory Affairs in the compliance with all relevant regulations, including FDA, ISO, and other international standards.
• Internal Audit: Support the Quality Assurance Manager in the service process’s evaluation in compliance with all relevant regulations, including FDA, ISO, and other international standards

Qualification – Required Knowledge, Skills and Abilities

• Knowledge of 2017/745(MDR) and 21 CFR 820
• Knowledge of 13485: 2021
• Skills:
  • Strong technical troubleshooting and problem-solving skills.
  • Excellent communication and collaboration abilities.
  • Good English Level (writing and speaking)
• Personal Attributes:
  • Ability to work independently and collaboratively across multifunctional teams.
  • Resilient and able to work effectively under stress and tight deadlines.
  • Willingness to travel as needed.

Minimum Required Education and Experience

• Experience: Minimum of 2 years of experience in the quality assurance role within the medical devices or healthcare industry, with a strong focus on service processes
• Education: Bachelor’s degree in engineering, or a related field.

Physical Requirements

• Expected travel is 20%

Purpose

Join the Quality Production Operations team to drive excellence in manufacturing and ensure the highest standards of quality and compliance in the production of advanced medical devices.

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities

• Production Support:
  • Oversee all processes related to the collection and review of the production records.
  • Review the Device History Records related to medical device products and ensure the correctly storage of records
  • Support the Medical Device Production Manager in the planning of the production process
  • Ensure that all production activities comply with regulatory standards, quality control protocols, and company policies
• Incoming Inspection: support the R&D ensure that the procedure for deciding when the lot under inspection is to be rejected or accepted.
• Equipment Management: manage the equipment calibration and archive the records
• Non conformities management: open and manage the non conformities issued during the production process, correction and corrective action
• Problem Solving: support the Medical Device Production Manager in the implementation of the corrective actions to minimize disruptions and maintain continuous production flow. Ensure that activities are correctly carried out and registered
• Supplier Management: perform the supplier qualification and supplier monitoring process and support the Quality Assurance Manager during the audit at the supplier
• Training: ensure that the training and guidance to production staff are correctly registered
• Design transfer: ensure that the design transfer activities are correctly carried out and registered
• Compliance: Support the Regulatory Affairs in the compliance with all relevant regulations, including FDA, ISO, and other international standards.
• Internal Audit: Support the Quality Assurance Manager in the production process’s evaluation in compliance with all relevant regulations, including FDA, ISO, and other international standards

Qualification – Required Knowledge, Skills and Abilities

• Knowledge of 2017/745(MDR) and 21 CFR 820
• Knowledge of 13485: 2021
• Skills:
  • Strong technical troubleshooting and problem-solving skills.
  • Excellent communication and collaboration abilities.
  • Good English Level (writing and speaking)
• Personal Attributes:
  • Ability to work independently and collaboratively across multifunctional teams.
  • Resilient and able to work effectively under stress and tight deadlines.
  • Willingness to travel as needed.

Minimum Required Education and Experience

• Experience: Minimum of 2 years of experience in the quality assurance role within the medical devices or healthcare industry, with a strong focus on production processes
• Education: Bachelor’s degree in engineering, or a related field.

Physical Requirements

• Expected travel is 20%

Purpose:

Director of Global Strategy and Business Development of Cosmo Intelligent Medical Devices.

Work Location: Europe, Remote

Key Responsibilities: 

• Strategic Planning: Develop and execute comprehensive global strategies to drive market expansion and business growth in the AI medical device sector.
• Market Analysis: Conduct in-depth market research to identify emerging trends, opportunities, and competitive landscape, providing actionable insights to the executive team.
• Business Development: Identify, evaluate, and establish strategic partnerships, alliances, and acquisitions to expand the company’s global footprint.
• Product Innovation: Collaborate with R&D and product teams to align product development with market needs and strategic goals.
• Leadership: Lead, mentor, and develop a high-performing team, fostering a culture of excellence, innovation, and continuous improvement.
• Stakeholder Management: Build and maintain strong relationships with key stakeholders.
• Performance Metrics: Establish and monitor key performance indicators (KPIs) to track progress against strategic goals and adjust strategies as necessary.
• Communication: Articulate strategic initiatives and business development plans effectively to internal and external stakeholders, such as Medtronic.

Qualification – Skills, and Abilities

• Experience: Minimum of 5 years of proven experience in global strategy and business development within the medical devices or healthcare industry. Focus on AI technologies preferred.
• Track Record: Demonstrated success in driving business growth, forming strategic partnerships, and leading high-impact projects.
• Education: Bachelor’s degree in Business Administration, Marketing, or a related field. MBA or advanced degree preferred.
• Personal Attributes:
  • Highly dynamic and adaptable to a fast-moving and innovative business environment.
  • Strong business acumen and entrepreneurial mindset.
  • Ability to work collaboratively across multifunctional teams and cultures.
  • Results-oriented with a proactive approach to problem-solving.
  • Flexibility and ability to travel. Preferred if based in a major European city.

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006

Purpose:

Senior  Systems Engineer to support the production and maintenance of Intelligent Medical Devices

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Medical Device production: create tools Linux based to improve the production line;
• scripting bash, python, javascript;
• AWS Cloud management and configuration (S3, IAM, security policies, auditing);
• Cyber security: prevention and implementation;
• Support in the information problems and analysis of the Root Cause of the medical devices.

Qualification – Required Knowledge, Skills and Abilities

• Proven expertise in Linux systems and networking (Debian/Ubuntu is preferable);
• Proven expertise in Cyber security;
• experience in database PostgreSQL administration and management (other databases are optional)
• the ability to manage customers and third parties;
• the aptitude to work in a team;
• personal motivation for professional growth;
• ability to adapt to changing projects and priorities.

The plus will be the knowledge of one or more of the following standards: ISO 9001, ISO 27001.

Minimum Required Education and Experience

• 4+ experience in the role (highly desirable);
• Informatics (or equivalent) master degree;
• Knowledge of ISO 27001;
• Linux systems and networking.

Qualification – Skills, and Abilities:

• analytical and problem-solving skills
• result orientation
• excellent interpersonal skills with customers and team members.
• skills in systems management, database administration and system security in Linux and Cloud environments.

Physical Requirements

• Expected travel is 30% in Italy

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006

We are seeking a skilled and detail-oriented Medical Image Annotation Specialist to join our dynamic team. The successful candidate will play a crucial role in the development of our AI algorithms by accurately annotating medical images.  We don’t mandate specific expertise in the field, as the selected candidate will receive training and constant updates by experts and healthcare professionals. Instead, we seek motivated, flexible, and quick-learning individuals eager to join our team in a friendly and collaborative environment. 

Work Location: Lainate (MI) – Italy – Via Cristoforo Colombo 1

Responsibilities: 

• Accurately annotate medical images using specialized tools. 
• Ensure high-quality and consistent annotations to support the training of AI algorithms. 
• Conduct thorough quality checks on images to identify inaccuracies. 
• Contribute to the continuous improvement of annotation processes and tools. 
• Participate in review sessions to enhance skills and stay updated on industry standards. 

Required Qualifications and Skills: 

• High School diploma. 
• Ability to quickly adapt to evolving annotation requirements and willingness to keep learning new annotation guidelines. 
• Strong ability to focus with a keen attention to detail and accuracy in annotation tasks. 
• Familiarity with PC and proficiency in Microsoft Office applications. 
• Excellent communication and collaboration skills.
   

This role entails a full-time, on-site position at our company office in Lainate (MI).
If you are passionate about contributing to the advancement of medical technology and possess the skills required for accurate medical image annotation, we invite you to apply. Join us in making a positive impact on healthcare and improving patient outcomes. 

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006