Quality and Regulatory Officer

Hertility

Quality & Regulatory Officer ensuring compliance in women's health products at Hertility. Supporting audits, documentation, risk management, and cross-functional collaboration.

Posted 7/14/2026full-timeRemote • 🇬🇧 United KingdomMid-LevelSenior💰 £35,000 - £40,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing controlled documents and quality assurance processes within regulated environments, with a strong focus on ISO 13485 and ISO 27001 compliance. Capable of conducting audits, managing corrective actions, and maintaining quality records while ensuring effective communication and organization.

Highest-signal resume keywords

ISO 13485 ExperienceISO 27001 ExperienceQuality Management System (QMS) ProficiencyDocument Control ManagementRoot Cause Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Document ManagementQuality AssuranceAudit SupportCorrective and Preventative Actions (CAPAs)Non-Conformance ManagementPost-Market Surveillance (PMS)Risk Register UpdatesDesign History FilesSupplier EvaluationTechnical Document Drafting

Soft Skills

Attention to DetailExcellent Written CommunicationProactive MindsetOrganizational SkillsAutonomy

Tools & Technologies

QualioQuality Management Systems (QMS)

Industry Keywords

Medical Device Regulatory FrameworksISO StandardsFDATGAMOHAP

About the role

Key responsibilities & impact

Assisting in the management of the lifecycle of controlled documents in Qualio (our QMS system), driving authors to meet review and approval deadlines.
Support standard operational procedures, work instructions, medical device technical documents and template drafting.
Assign training and track completion for document updates.
Help organise internal quality records, logs and dashboards.
Support with internal and external audits against ISO 13485 and ISO/IEC 27001 standards.
Support Corrective and Preventative Actions (CAPAs), Non-Conformances (NC), change controls and follow up actions, including timely and structured root cause analysis (e.g. 5 whys, fishbone) and tracking effectiveness.
Drive audit readiness by maintaining organised evidence logs aligned to ISO 13485 and ISO 27001 requirements and contributing to ongoing quality assurance activities.
Coordinate the collection of Post-Market Surveillance (PMS) inputs.
Support risk register updates and Design History Files.
Contribute to Management Review quality reporting.
Support with Supplier Onboarding, Supplier Evaluation Reports and ongoing supplier monitoring.
Conduct quality checks on our medical device components and logistics providers, escalating non conformances independently.

Requirements

What you’ll need

A minimum of 3 years experience in a Quality/Regulated setting.
Experience with ISO 13485 (Medical Device), ISO 27001 (ISMS) or regulated environments.
Exposure to International Medical Device Regulatory Frameworks (e.g. FDA, TGA, MOHAP).
Strong attention to detail and structured approach to organisation and process management.
Excellent written communication and documentation skills.
A proactive, curious mindset with the ability to manage tasks independently and follow through to completion.
Comfortable working remotely with high levels of autonomy and accountability.
Willingness to travel, occasionally to London for audits, team sessions or key activities.

Benefits

Comp & perks

33 Days of Paid Leave: Includes public holidays, 3 Days Discretionary Additional time off between Christmas and New Year.
Company Laptop: The tech you need to succeed!
Remote-First: Work from anywhere with the flexibility to do what matters most to you.
Flexible Working Hours: 40 hours per week, with the freedom to choose your start and finish times.
Wellbeing: Receive a £40 monthly wellbeing 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: In house counselling available anytime.
Free Hertility Services: Complimentary hormone and fertility tests for you, plus discounts for friends and family.
Enhanced Parental Leave & First-Time Parents Benefits: Support through all stages of family life.
Menstrual Leave: Time to rest and restore when your body’s rhythms change.
Financial Advisor Access: Get guidance on financial planning.
Work from Anywhere: Embrace true flexibility with the option to work from anywhere in the world, one month per destination, up to 12 countries across 12 months.