About Ostique

Ostique is a medtech startup revolutionising ostomy care with innovative solutions. We are seeking a Regulatory Affairs & Quality Manager to ensure our regulatory compliance, quality systems, and audits remain on track throughout an employee’s maternity leave.

This role requires someone with experience in medical device compliance (ISO 13485, MDR, UKCA, QMS management) and the ability to oversee regulatory documentation and audits. Knowledge of the NHS and Drug Tariff would be ideal.

Key Responsibilities

Regulatory Compliance

• Maintain and update our Quality Management System (QMS) to ensure compliance.
• Review and update Standard Operating Procedures (SOPs), ensuring documentation is filed correctly.
• Ensure compliance with ISO 13485, MDR, UKCA, and SFDA regulations (FDA experience would be welcomed).
• Keep technical files for UK/EU and SFDA updated.
• Liaise with regulatory consultants and EU representative.
• Handle Drug Tariff applications and other necessary regulatory processes as may arise.

Quality Assurance & Audits

• Lead internal audits, ensuring compliance with regulatory standards.
• Prepare for and manage external audits.
• Conduct post-market surveillance (PMS) and track key activities/ metrics such as customer complaints.
• Work with the Head of Product to ensure regulatory compliance in design and manufacturing.

Compliance Oversight & Risk Management

• Act as the Management Representative for the company’s quality system.
• Report to the board on QMS effectiveness and necessary improvements.
• Ensure regulatory awareness across the team and provide training.
• Implement Corrective and Preventive Actions (CAPAs) as needed.

What We 're Looking For

• 5+ years of experience in regulatory affairs and quality management (medical devices).
• Strong understanding of ISO 13485, MDR, QMS, and regulatory documentation.
• Knowledge and understanding of the NHS/ Drug Tariff welcomed
• Experience in audits, SOPs, CAPAs, and PMS.
• Ability to manage compliance across multiple areas independently.
• Comfortable working in a startup environment with hands-on responsibilities.

What We Offer

• Competitive salary.
• Flexible work arrangements (remote).
• Opportunity to lead regulatory affairs for a growing startup.
• A fast-paced and collaborative work culture.

Job Types: Part-time, Fixed term contract
Contract length: 6 months

Pay: £50,000.00 per year

Expected hours: 24 per week

Benefits:

• Work from home

Schedule:

• Flexitime
• Monday to Friday

Work Location: Remote

Reference ID: OSTIQUE -R&Q AFFAIRS
Expected start date: 05/05/2025