Job Description

Key Responsibilities

• Write and maintain technical files for our products as regulations require, working closely with R&D, Product and Clinical teams.
• Keep our QMS up to date: draft and review procedures, manage document control, and make sure processes reflect how we actually work.
• Help prepare and run internal and external audits, including notified body and FDA inspections, and follow up on findings with clear corrective and preventive actions (CAPA).
• Support product registrations and renewals in new and existing markets, handling submissions and questions from authorities and distributors.
• Monitor regulatory changes and translate them into practical actions for the organization.
• Support post-market surveillance, complaint handling and vigilance reporting.
• Train colleagues, customers and partners on quality and regulatory topics so they get the most out of our clinical solutions while staying compliant.
• Act as a go-to contact for quality and regulatory questions across the company, helping teams build compliance into their daily work from the start.

Qualifications

• You are located in Australia, India, The Philippines or in another APAC country.
• A Bachelor's or Master's degree in a relevant field, such as biomedical engineering, life sciences, health sciences or technical medicine.
• At least 2 years of experience in quality assurance and/or regulatory affairs in the medical device industry. Experience with software as a medical device (SaMD) or AI-based products is a big plus.
• Hands-on experience with ISO 13485 and the EU MDR, and a working knowledge of FDA requirements (QMSR, 510(k)).
• Familiarity with related standards such as IEC 62304, ISO 14971 and IEC 62366.
• Experience writing and maintaining technical documentation and supporting audits by notified bodies or regulators.
• A structured, precise way of working, with a practical, solution-focused mindset. You know how to make compliance work in a fast-moving scale-up.
• Strong communication skills, so you can explain regulatory requirements clearly to engineers, clinicians, customers and partners.
• Fluent English, written and spoken, additional language is a plus
• Proactive, independent and eager to learn about international market registrations as the company grows.

We Offer

• Chance to make a real difference in patients' lives
• Work in a stimulating environment with a motivated team
• Flexible Employment Agreement: Part time / Full time / Freelance
• Flexible working hours
• Flexible paid time off*
• Laptop + home office/IT equipment*
• Commuting to work - costs reimbursement
• Pension plan scheme*
• Employee Stock Option Plan (ESOP)*
• Corporate programs including Employee Referral Program with rewards
• Learning & Development opportunities including in-house training and coaching, professional certifications, and over 22,000 courses on LinkedIn Learning Solutions and much more

Application Process

• Interview with HR
• Interview Hiring Manager
  - Prior employment verification check (reference check)
• Meet & Greet CEO