Compliance Manager - Hybrid - Medical Devices

REED Specialist Recruitment; Enniskillen; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A healthcare technology company in Enniskillen is seeking a Compliance Manager to ensure compliance with regulatory frameworks like ISO 13485 and GDPR. The role involves managing audits, certification maintenance, and developing compliance documentation. Candidates should possess strong knowledge of ISO standards and excellent leadership skills. This position offers a competitive salary, hybrid working model, and professional development opportunities.

Benefits

Competitive salary based on experience

Pension and benefits package

Ongoing professional development and training

Hybrid working model

Qualifications

• Strong knowledge of ISO, GDPR, and ideally DAMAS, MHRA, MDR.
• Excellent communication and documentation skills.
• Ideally experience in compliance within a medical device or healthcare environment.

Responsibilities

• Manage and maintain regulatory certifications and registrations.
• Develop and update SOPs, policies, and compliance documentation.
• Lead internal and external audits, ensuring timely corrective actions.
• Monitor regulatory changes and ensure company-wide compliance.
• Oversee GDPR and cybersecurity compliance in collaboration with IT.

Skills

ISO Compliance

GDPR knowledge

Medical Device regulations

Proficiency in QMS software

Leadership skills

Education

ISO/Internal Auditor certification

Job description

Overview

Compliance Manager - Hybrid (Enniskillen)

Location: Enniskillen - Hybrid (up to 3 days/week WFH)
Salary: Competitive (based on experience)
Contract Type: Full-time, Permanent

Are you a detail-driven compliance professional with a passion for quality and regulatory excellence? Join our client, a forward-thinking healthcare technology company, in a newly created Compliance Manager role and play a pivotal role in maintaining our high standards across medical device and healthcare operations.

About the Role

As Compliance Manager, you\'ll lead the charge in ensuring our organisation remains fully compliant with key regulatory frameworks including ISO 13485, DAMAS, MHRA, and MDR. You\'ll manage audits, maintain certifications, and drive continuous improvement across our quality systems-all while working in a flexible hybrid environment.

Key Responsibilities

• Manage and maintain regulatory certifications and registrations.
• Develop and update SOPs, policies, and compliance documentation.
• Lead internal and external audits, ensuring timely corrective actions.
• Monitor regulatory changes and ensure company-wide compliance.
• Oversee GDPR and cybersecurity compliance in collaboration with IT.
• Ensure documentation control and traceability for regulated products.

What We\'re Looking For

• Strong knowledge of ISO, GDPR, and ideally DAMAS, MHRA, MDR (training available).
• Excellent communication, documentation, and leadership skills.
• Proficiency in QMS software systems.
• ISO/Internal Auditor certification preferred.
• Ideally experience in compliance, ideally within a medical device, healthcare, or regulated manufacturing environment.

Personal Attributes

• High integrity and confidentiality.
• Proactive, solution-focused mindset.
• Strong organisational and time management skills.
• Ability to influence and engage across all levels of the business.

What We Offer

• Competitive salary based on experience
• Pension and benefits package
• Ongoing professional development and training
• Hybrid working model (up to 3 days a week from home)

Skills: ISO Compliance Medical Devices