Head of Regulatory and Quality
Do you have a deep and practical understanding of international medical device regulations? Are you excited by the regulatory and QMS intricacies of software as medical devices? If realising the international regulatory strategy of new technology is the challenge you’ve been looking for, we would love for you to join our journey.
About the business
Formus Labs is a New Zealand-based company developing ground-breaking software solutions to improve joint replacement surgery. Our cloud-based platform is a World-first in employing state-of-the-art biomechanics and AI to help surgeons create optimal surgical plans for each individual patient. Our technology has already empowered surgeons and global orthopedic companies to provide best-in-class joint-replacement surgery to hundreds of patients.
Spun out from the world-renowned Auckland Bioengineering Institute, we are a dynamic start-up with a highly talented team from diverse personal and professional backgrounds, including Stanford, Autodesk, Trimble, and Corin. This team has built an amazing product and we want you to join us on this journey.
Formus Labs has an ISO 13485 certified quality management system (QMS) for a software product. Our product, the Formus Platform, is a software as a medical device. Applications on the Formus Platform currently have regulatory approval in New Zealand and Australia, with US FDA 510(k) approval in progress.
About the role
Formus Labs is looking for a highly experienced regulatory and quality operator to lead the continual development and execution of our regulatory strategy across multiple international markets. You will also be working across our QMS to continuously improve internal processes to meet and maintain regulatory requirements.
- Working closely with the team to refine and maintain the company regulatory strategy in alignment with commercial and product strategies.
- Translate international regulatory standards into practical and efficient internal procedures to ensure our compliance in a way that is fit-for-purpose in a software development environment.
- Working together with the relevant territory sponsor to ensure regulatory approval, compliance, and maintenance of regulatory status.
- Coordinate and help with the preparation and collation of technical documentation for regulatory submissions.
- Provide guidance on all aspects of regulatory compliance within a cross-functional team thus ensuring product quality and customer satisfaction.
- Maintaining our ISO 13485 Certification and expanding its scope when necessary.
- Ensuring that QMS documents are up to date and new processes are included into the QMS.
- Maintain the Audit Program, managing internal audits and external audits.
- Oversee the operation of the QMS across product development, customer complaints, CAPA, customer feedback, supplier management, and Training systems.
Benefits and Perks
You will enjoy...
- Being part of a high-growth venture-backed start-up with international users and customers
- Competitive remuneration package with the possibility of incentives and share options.
- Generous private NZ health insurance
- Flexible working environment with a highly functional remote-work culture.
- Collaborating with a team of talented individuals to make a real difference in patients’ lives.
Skills and Experience
You will have...
- A regulatory and quality background backed by a minimum of five years working experience within the medical device industry, ideally within the software as a medical device sector.
- Experience formulating and executing regulatory strategies for medical devices involving FDA 510(k), TGA, NZ MedSafe, and CE marking – covering documentation, compliance, vigilance, and post-market reporting.
- Experience with tech or software product development under ISO 13485:2016, ISO 14791:2019, ISO 62304:2015, and ISO 82304.
- Ideally, knowledge of anatomy and/or orthopedics.
- Motivation to drive continuous improvement through innovation.
- Excellent oral and written communication and the ability to effectively communicate throughout the organisation.
- Excellent interpersonal skills and a desire to engage and learn from others as well.
- Work well autonomously and within a team.
- A passion for software technology in the medical field