Role Description: The Regulatory Affairs Lead is a full-time role based in Singapore. This role is responsible for overseeing regulatory strategies, ensuring compliance with local and international regulations, and guiding the preparation and submission of documentation for approvals and certifications. Day-to-day tasks include managing regulatory submissions for medical technologies, coordinating with cross-functional teams (clinical, engineering, and product) to align regulatory plans with development timelines, and maintaining up-to-date knowledge of evolving regulatory frameworks. The Regulatory Affairs Lead will review and update standard operating procedures, liaise with regulatory authorities and notified bodies, and support risk management and quality assurance activities. This role also involves advising leadership on regulatory implications of product changes and helping to shape the company’s long-term regulatory roadmap.

Key Responsibilities

• Strong expertise in regulatory affairs, including experience developing and implementing Regulatory Affairs strategies and managing Regulatory Requirements.
• Proficiency in Regulatory Documentation, with a track record of preparing and reviewing technical files, clinical evidence, and supporting materials.
• Hands-on experience with Regulatory Submissions, including interacting with regulatory agencies and navigating approval processes.
• Demonstrated ability to ensure Regulatory Compliance across products and processes in the medical device, healthcare, or related neurotechnology sectors.
• Own and maintain a quality management system.
• Manage post-market surveillance, complaint handling, vigilance reporting, and CAPA processes across all markets.
• Track evolving requirements (including for AI/software-driven medical devices) and translate them into practical guidance for the product and clinical teams.

Qualifications

• Bachelor’s or Master’s degree in a relevant field such as biomedical engineering, life sciences, regulatory science, or a related discipline.
• Knowledge of regional and international regulatory frameworks (e.g., HSA Singapore, FDA, CE/MDR) and quality management standards (e.g., ISO 13485).
• Experience with imaging software, software as a medical device (SaMD), or AI/ML-enabled devices strongly preferred.
• ISO 13485 Internal Auditor certification
• Strong analytical, documentation, and project management skills, with the ability to work collaboratively with multidisciplinary teams.
• Excellent written and verbal communication skills in English; attention to detail and a structured approach to problem-solving.

Preferred experience

• Experience in neuromodulation, neurotech, or psychiatry/neurology-adjacent devices.
• Regulatory Affairs Certification or equivalent professional certification.

How to apply

Email hello@b1neuro.com with:

• Subject line: Application: [Role Title] – [Your Name] (e.g. “Application: Regulatory Affairs Lead – Jane Tan”)
• In the body, please include:
  1) Years of medtech regulatory affairs experience
  2) Relevant ISO 13485:2016 certifications
  3) Eligibility to work in Singapore
  4) Notice period
  5) Why B1Neuro, specifically? (2–4 sentences)
• Attach: your CV (PDF preferred)

Role Description: The TMS Technician is a full-time role based in Singapore. This role is responsible for the day-to-day delivery of TMS (transcranial magnetic stimulation) treatment sessions in a clinical setting. Day-to-day tasks include operating TMS equipment for patient sessions in accordance with clinical protocols, scheduling and coordinating patient appointments, and maintaining accurate treatment records. The TMS Technician works closely with clinicians and the broader care team to ensure patients receive safe, consistent, and well-documented treatment, and may take on other clinical support duties as the clinic’s needs evolve.

Key Responsibilities

• Operate TMS equipment to deliver treatment sessions in accordance with clinical protocols and physician-prescribed parameters.
• Schedule and coordinate patient appointments, managing treatment calendars across multiple patients.
• Monitor patients during treatment sessions and respond appropriately to any discomfort or adverse events.
• Maintain accurate, timely treatment session records and patient documentation.
• Ensure equipment is properly calibrated and maintained, escalating any issues promptly.
• Follow all clinical safety protocols and infection control procedures.
• Support other clinical operations as needed, including patient intake and clinic coordination.

Qualifications

• Diploma or degree in a relevant healthcare, allied health, or biomedical field (e.g., nursing, occupational therapy, psychology, biomedical sciences), or equivalent relevant clinical experience.
• Comfortable working directly with patients in a clinical setting.
• Strong organizational skills, with experience scheduling or coordinating patient appointments.
• Meticulous, safety-conscious approach to operating medical equipment.
• Good written and verbal communication skills in English; able to explain procedures clearly and reassure patients.

Preferred experience

• Prior experience with TMS (transcranial magnetic stimulation) equipment or protocols
• BCLS (Basic Cardiac Life Support) certification
• Experience in a psychiatric, neurology, or mental health clinical setting

How to apply

Email hello@b1neuro.com with:

• Subject line: Application: [Role Title] – [Your Name] (e.g. “Application: TMS Technician – Jane Tan”)
• In the body, please include:
  1) Years of clinical or patient-facing experience TMS equipment experience or familiarity (if any)
  2) BCLS certification status (and expiry, if applicable)
  3) Eligibility to work in Singapore
  4) Notice period
  5) Why B1Neuro, specifically? (2–4 sentences)
• Attach: your CV (PDF preferred)