Regulatory Specialist (with Medical devices Experience)
Share
Job Location:
Monthly Salary:
Posted on:
30-10-2025
Vacancies:
1 Vacancy
Job Summary
Your mission
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 worlds thinnest and nobel-prize winning material to build high resolution neural systems.Our mission is to decode and modulate neural networks to restore peoples lives.
As aRegulatory Specialistat 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 peoples lives worldwide.
Your profile
Main responsibilities:
- Verification and validation plan developmentin accordance withapplicable regulatory requirements.
- Supplier sourcing and qualificationfor testing activitiesunder accredited programs such asIECEE CB Scheme EU MDR conformity assessment ASCA-FDA PMDA Health Canada ARTG-TGA.
- Medical Device File / Technical Documentationcompilation and coordination for regulatory submissions and product registration.
- PMSand PMCFactivities coordinationandreportingto relevant Regulatory Authorityin the identified geographies.
- Periodic reporting of regulatoryinformation to relevantauthoritiesfor products undergoing clinical investigations.
- Monitoring of applicable regulatory requirements andupdateofidentifiedtechnical documentation.
- Identification ofcommittees of interest(ISO CEN-CENELEC ANSI and other international initiatives)of participation in necessary activitiesforpolicy making and industry standardization.
- Participate oninternal and external auditsfor the assessment of conformity to regulatory requirements in projects and QMS activities in scope (PMS PMCF Periodic reporting).
Mandatory Qualifications and Soft skills:
- Bachelors orMastersdegree inLife scienceBiomedical Engineering Regulatory Affairs or related field.
- Minimum 35 years of experience in regulatory affairs within the medical device industry.
- Provenexpertisein biocompatibility testing and regulatorysubmissions for(forimplantable devicespreferably butoptional).
- 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.
Why us
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 youll 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. Youll 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. Youll 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 were not just offering a job were 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.
About us
Learn more about us at INBRAIN
Required Experience:
IC
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
- Facilities
- IT Support
