Compliance and Regulatory Manager - Digital Health (SaMD)

We're looking for someone with hands-on experience in quality, regulatory and compliance management within healthtech or medical devices.

You'll understand medical device regulation, quality management systems and GDPR, including how compliance requirements differ across international markets. More importantly, you'll know how to put those requirements into practice, bringing teams together, improving processes and making sure things get done.

You'll be successful in this role if you have experience in:

Medical device regulation: Practical experience with medical device classification, registration and ongoing regulatory compliance, ideally involving Software as a Medical Device (SaMD) and Class IIa requirements.

• →Quality management: Experience implementing, maintaining and improving a Quality Management System, including ISO 9001 and ideally ISO 13485.
• →Data protection and international privacy regulation: Strong working knowledge of UK and EU GDPR, with practical experience managing data protection compliance across multiple jurisdictions.
• →Information governance and security: A good understanding of information security and governance requirements, with experience coordinating compliance activities, assurance or certifications such as NHS DSPT, Cyber Essentials or ISO 27001.
• →Quality assurance: Experience managing internal audits, corrective and preventive actions (CAPAs), document control, change management, risk assessments and continuous improvement.
• →Process implementation: Experience developing clear policies, procedures and controls, and ensuring they are consistently adopted and followed across an organisation.
• →Stakeholder management: Experience working with cross-functional teams, technical specialists, external advisers and senior stakeholders to drive accountability and improvements.

Nice to have:

• →Experience navigating international healthcare and medical device regulations, including UK MHRA requirements, EU MDR or equivalent frameworks in markets such as Australia.
• →Experience acting as a Quality Management Officer (QMO) or holding responsibility for a QMS in a regulated organisation.
• →Experience acting as a designated Data Protection Officer (DPO), ideally within healthcare technology or an organisation handling sensitive personal data.
• →Experience with regulatory submissions, technical documentation, post-market surveillance or medical device certification.
• →Experience coordinating penetration testing, security assessments or remediation programmes.
• →Experience working in a healthtech startup or scale-up where you've helped establish or significantly improved compliance processes.

We appreciate you may not meet every requirement listed above. If you're excited by the role and believe you could make a meaningful contribution at Isla, we'd love to hear from you.

Interviewing with us for the role will be split into 3 stages:

1. A screening interview with someone from our Operations team- 15 minutes
2. An interview with our Senior Operations Manager - 1 hour
3. A final interview with our Co-founder CTO and MDR Consultant  - 30 minutes

Isla is an equal opportunity employer and is committed to building an inclusive and diverse team. We encourage all qualified candidates to apply. Isla does not discriminate against anyone on the basis of their race, gender, disability, religion, national origin, age, or any other protected category. We choose to celebrate our team’s differences and see them as one of our most valuable assets.Recruitment is not one-size-fits-all and we're happy to tailor our hiring process to better meet the needs of individual applicants. Please email recruitment@isla.health with any requests for support.