Regulatory Affairs Specialist

Aevice Health is a fast-growing medtech startup that develops the world's smallest US FDA-cleared, Australia TGA-approved and Singapore HSA-approved smart wearable stethoscope, along with mobile platforms and analytics, to improve the lives of patients with chronic respiratory diseases. Currently operating in Singapore and the US, and backed by a US health system and a Japanese medical device manufacturer, our team of innovators and medical professionals are dedicated to creating convenient solutions for complex, real-world problems. At Aevice Health, we invest in individuals who embrace creativity and take ownership of their work. We work in small teams to experiment with new ideas, iterate quickly, and develop cutting-edge products.

We are looking for a Regulatory Affairs Specialist to actively support the development and execution of regulatory strategies, handle regulatory submissions, and ensure our products comply with the relevant requirements in the markets where we operate. You will work closely with cross-functional teams to provide practical regulatory guidance and help drive timely approvals.

Responsibilities

• Support the planning and development of regulatory strategies aligned with market needs under the guidance of senior stakeholders.

• Prepare and compile product registration dossiers and license applications, ensuring submissions are accurate, complete, and comply with applicable regulatory requirements.

• Draft and submit change notifications to regulatory authorities follow up to ensure timely approvals.

• Coordinate regulatory submission activities by tracking timelines, gathering documentation, and ensuring submissions meet internal quality standards.

• Collaborate with cross-functional teams (e.g., R&D, Quality, Clinical) to gather inputs for regulatory submissions and ensure alignment in execution.

• Prepare and file license renewals and maintain timely documentation updates.

• Assist in preparing reports for Field Safety Corrective Actions or Adverse Events under supervision, ensuring regulatory reporting obligations are met.

• Communicate with regulatory agencies on submission-related matters, with support from senior leadership when needed.

• Maintain product registration records and databases, ensuring they are up to date and audit-ready.

• Keep abreast of changes in regulatory requirements support internal interpretation and documentation updates where applicable.

• Provide updates to relevant teams on regulatory changes that may affect product registration or compliance.

• Support the Quality team in the preparation of internal audits and compliance with ISO 13485 and other relevant QMS standards.

• Participate in external audit preparation by helping compile documentation and addressing follow-up actions.

Requirements

Technical Skills:

• Bachelor's Degree in Biomedical Science, Engineering, or a related discipline

• 2-5 years of experience in medical device regulatory affairs, including full lifecycle exposure to submissions and QMS support

• Good understanding of HSA, TGA and FDA Class I/II regulatory pathways, with ability to interpret and apply guidance documents

• Independently prepares and submits product registration dossiers, change notifications, and license renewals with minimal oversight

• Proficient in maintaining product registration databases, ensuring document control, and supporting post-market surveillance activities

• Experienced in compiling audit-ready documentation and contributing to internal or external audit processes

• Comfortable drafting new regulatory templates and process documents in alignment with changing requirements

Soft Skills:

• Works independently with high ownership over assigned regulatory deliverables and timelines

• Exercises sound judgment in navigating ambiguous regulatory scenarios, escalating only complex or business-impacting issues

• Confident representing RA function in cross-functional meetings to align timelines, gather inputs, and clarify compliance expectations

• Maintains strong situational awareness in a dynamic startup context, balancing proactive compliance with practical execution

• Demonstrates increasing confidence in advising internal stakeholders on regulatory impacts related to product changes or market expansion

• Communicates clearly and professionally with internal teams and regulatory bodies, including through formal submissions and correspondence