Regulatory Affairs Specialist
Remote
To help us manage applications fairly, please apply via this job advert only. We kindly ask candidates not to contact Mirada employees directly, as only applications submitted through this advert will be considered.
About Mirada Medical Ltd
Mirada is a global medical imaging software company specialising in oncology, working with hospitals, clinicians, and industry partners worldwide. Our software supports clinicians in delivering high quality patient care, and we work closely with customers, distributors, and partners across EMEA, the US, and APAC.
The role
We are seeking a Regulatory Affairs Specialist with hands-on experience in software medical devices to join our Regulatory Affairs and Quality team, which sits within Product and supports the business at both a corporate and regional level.
This role is responsible for supporting regulatory compliance across multiple regions, including the EU and US. You will be involved in preparing and reviewing regulatory submissions, maintaining technical documentation, supporting software development projects from a regulatory perspective, and managing post market surveillance and vigilance activities.
Working closely with Product, Engineering, QA, and external partners, you will play a key role in ensuring Mirada’s products continue to meet applicable regulatory and quality requirements as the business grows.
Job summary
The Regulatory Affairs and Quality department supports Mirada at a global level, ensuring compliance with regulatory requirements across all applicable regions and supporting the business in meeting required quality standards and objectives.
The Regulatory Affairs Specialist reports into RA leadership and is responsible for regulatory compliance, regulatory submissions, and supporting regulatory planning and execution across the organisation. Where required, this role may act as a Person Responsible for Regulatory Compliance (PRRC) as defined by Regulation (EU) 2017/745 (MDR).
Key responsibilities
* Overseeing and managing regulatory affairs activities across the business and product portfolio
* Supporting regulatory planning, estimation, and management of RA work
* Preparing and managing regulatory submissions, including EU MDR technical files and FDA 510(k) submissions
* Managing new and existing regional product registrations and licences
* Acting as PRRC when required
* Supporting in country representatives with regulatory requests and submissions
* Compiling, maintaining, and reviewing product technical documentation
* Advising Product and Engineering teams on regulatory requirements across different regions
* Developing regulatory strategies for new products and territories
* Identifying, assessing, and implementing new or updated regulatory and quality requirements
* Liaising with regulators, notified bodies, external consultants, and other third parties
* Supporting and participating in external audits
* Ensuring regulatory input throughout product development, including review of risk management, usability, cybersecurity, and clinical documentation
* Producing and maintaining clinical documentation such as CEP, CER, PMCFP, and PMCFR where required
* Producing and maintaining post market surveillance documentation including PMSP, PMSR, and PSUR
* Managing vigilance activities and reporting reportable events to regulatory authorities
* Chairing meetings to review escalated complaints presenting potential hazards
* Reviewing business to business contracts and marketing materials from a regulatory perspective
* Collaborating closely with QA on SOPs, internal audits, and management review activities
* Supporting other RAQA team members and wider business activities as required
Essential skills and experience
* Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Computer Science, Regulatory Affairs, or a related discipline
* Experience working in a regulatory role within a medical device company
* Experience with regulatory submissions for medical devices, including EU MDR and FDA 510(k)
* Strong knowledge of ISO 13485:2016 and MDSAP
* Knowledge of ISO 14971, IEC 62304, and ISO 62366-1
* Ability to understand and review technical documentation such as product requirements and test specifications
* Ability to communicate regulatory requirements clearly and translate them into practical guidance for teams
Preferred skills and experience
* Experience working with software medical devices
* Knowledge of medical device regulations across additional regions such as Japan, Brazil, and Canada
* Experience authoring EU MDR clinical documentation including CEP, CER, PMCFP, and PMCFR
* Familiarity with regulatory software tools, document control systems, and eQMS platforms
* Awareness of medical imaging modalities such as CT, MRI, PET, SPECT, or nuclear medicine
* Awareness of radiopharmaceutical dosimetry and radioligand therapy
Why join Mirada
You will be part of a collaborative, international team working at the forefront of medical imaging software. This role offers the opportunity to work closely with Product, Engineering, and Quality teams, contributing directly to the development and ongoing compliance of clinically impactful software products.
If you enjoy working in a fast paced environment, partnering closely with Product and Engineering teams, and taking ownership of regulatory activities across a growing product portfolio, we would love to hear from you.