Quality and Regulatory Officer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Assisting in managing the lifecycle of controlled documents within Qualio (our QMS system), ensuring that authors adhere to review and approval timelines.

• Supporting the drafting of standard operational procedures, work instructions, technical documents for medical devices, and templates.

• Assigning training and monitoring the completion of updates to documents.

• Helping to organize internal quality records, logs, and dashboards.

• Aiding in internal and external audits in accordance with ISO 13485 and ISO/IEC 27001 standards.

• Supporting Corrective and Preventative Actions (CAPAs), Non-Conformances (NC), change controls, and follow-up actions, including timely and structured root cause analyses (e.g., 5 whys, fishbone) and tracking effectiveness.

• Ensuring audit readiness by maintaining organized evidence logs that align with ISO 13485 and ISO 27001 requirements, while contributing to ongoing quality assurance efforts.

• Coordinating the collection of Post-Market Surveillance (PMS) inputs.

• Assisting with updates to the risk register and Design History Files.

• Contributing to quality reports for Management Review.

• Supporting Supplier Onboarding, Supplier Evaluation Reports, and ongoing monitoring of suppliers.

• Conducting quality checks on our medical device components and logistics providers, independently escalating any non-conformances.

⛳️ Requirements

• A minimum of 3 years of experience in a Quality/Regulated environment.

• Familiarity with ISO 13485 (Medical Device), ISO 27001 (ISMS), or other regulated settings.

• Exposure to International Medical Device Regulatory Frameworks (e.g., FDA, TGA, MOHAP).

• Strong attention to detail and a structured approach to organization and process management.

• Excellent written communication and documentation abilities.

• A proactive and curious mindset, capable of independently managing tasks and ensuring their completion.

• Comfortable working remotely with high levels of autonomy and accountability.

• Willingness to travel occasionally to London for audits, team sessions, or other key activities.

🏝️ Benefits

• 33 Days of Paid Leave: Includes public holidays, plus 3 discretionary days off between Christmas and New Year.

• Company Laptop: The technology you need to thrive!

• Remote-First: Work from anywhere with the flexibility to prioritize what matters most to you.

• Flexible Working Hours: 40 hours per week, with the freedom to determine your start and finish times.

• Wellbeing: Receive a £40 monthly allowance to spend on anything that brings you joy.

• Pension Scheme: 5% employer contribution salary sacrifice pension with a 5% employee match.

• Mental Health Support: Access to in-house counselling available anytime.

• Free Fertility Services: Complimentary hormone and fertility tests for you, along with discounts for friends and family.

• Enhanced Parental Leave & First-Time Parents Benefits: Support throughout all stages of family life.

• Menstrual Leave: Time to rest and recover when your body’s rhythms shift.

• Financial Advisor Access: Receive guidance on financial planning.

• Work from Anywhere: Enjoy true flexibility with the option to work from anywhere in the world, one month per destination, up to 12 countries across 12 months.