We are scientists, doctors, techies and humanity lovers, with the mission of pioneering real time precision neurology to cure brain-related disorders. INBRAIN harnesses the extraordinary material properties of Graphene, the world’s thinnest and nobel-prize winning material, to build high resolution neural systems. Our mission is to decode and modulate neural networks to restore people's lives.

As a Regulatory Specialist at INBRAIN, you will focus in the verification and validation activities necessary for the adequate evaluation of safety and effectiveness of the devices being developed by INBRAIN. This position will coordinate, evaluate and compile the verification and validation activities including, but not limited to biocompatibility, cleanliness and sterilization, electrical safety, electromagnetic compatibility, accelerated aging, packaging and labelling, etc.

You will be at the forefront of bringing advanced healthcare solutions to market, making a tangible difference in people´s lives worldwide.

Main responsibilities:

• Verification and validation plan development in accordance with applicable regulatory requirements.
• Supplier sourcing and qualification for testing activities under accredited programs such as IECEE CB Scheme, EU MDR conformity assessment, ASCA-FDA, PMDA, Health Canada, ARTG-TGA.
• Medical Device File / Technical Documentation compilation and coordination for regulatory submissions and product registration.
• PMS and PMCF activities coordination and reporting to relevant Regulatory Authority in the identified geographies.
• Periodic reporting of regulatory information to relevant authorities for products undergoing clinical investigations.
• Monitoring of applicable regulatory requirements and update of identified technical documentation.
• Identification of committees of interest (ISO, CEN-CENELEC, ANSI and other international initiatives) of participation in necessary activities for policy making and industry standardization.
• Participate on internal and external audits for the assessment of conformity to regulatory requirements in projects and QMS activities in scope (PMS, PMCF, Periodic reporting).

Mandatory Qualifications and Soft skills:

• Bachelor’s or Master’s degree in Life science, Biomedical Engineering, Regulatory Affairs, or related field.
• Minimum 3–5 years of experience in regulatory affairs within the medical device industry.
• Proven expertise in biocompatibility testing and regulatory submissions for (for implantable devices preferably but optional).
• Fluent in English (both written and spoken) as it is the company language
• Strong understanding of ISO 10993, EU MDR, FDA regulations, and risk management principles.
• Excellent communication and cross-functional collaboration skills.
• Detail-oriented with strong organizational and documentation capabilities.

Nice to have:

• Experience with neurological or neurostimulation devices.
• Familiarity with electronic health record (EHR) integration and digital health regulations.
• Certification in Regulatory Affairs (e.g., RAPS RAC) is a plus.

We are looking for someone who Is ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. At INBRAIN we believe in shared success and diverse ways of thinking, here you'll learn, grow, and advance in an innovative culture.


WHAT CAN WE OFFER TO YOU?

• A collaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect.
• Meaningful Work Impact: Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You'll be part of a team that strives to create meaningful change.
• Cutting-Edge Technology Exposure: Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state-of-the-art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry.
• Competitive salary (according to your experience/skills)
• Payflow & Flexflow
• Private Health Insurance
• Training bonus for professional development and access to Udemy platform
• 23 vacation days per year
• Christmas week off
• Hybrid working modality

Applications must be submitted in English

At INBRAIN, we're not just offering a job – we're inviting you to be part of a transformative journey, Are you ready to transform lives? Join us!

#diverseandinclusive
We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation, identity and diverse abilities or any other status.

Learn more about us at INBRAIN NEUROELECTRONICS. com