Cyber Security Consultant

Cybersecurity Regulatory Affairs Consultant Fully Remote UK-Based Medical Device Company Contract

Maclivaro are working with an innovative UK-based medical device company who are looking for an experienced Cybersecurity Regulatory Affairs Consultant to provide specialist regulatory expertise across software and cybersecurity within the medical device environment.

This is a specialist contract opportunity for someone with deep, repeated experience in the regulatory aspects of medical device software and cybersecurity.

The business already has strong in-house expertise across a number of areas, so they are specifically looking for an independent consultant who can bring additional regulatory depth and specialist knowledge in software and cybersecurity.

The Role

You will provide regulatory guidance and hands on support relating specifically to software and cybersecurity requirements for medical devices, helping the business ensure its products, processes and documentation meet applicable regulatory expectations.

The successful consultant will have extensive experience working at the intersection of Regulatory Affairs, Software and Cybersecurity, with a strong understanding of how cybersecurity requirements translate into medical device regulatory submissions, technical documentation and compliance activities.

This is not a general cybersecurity role. We are looking for someone who has repeatedly worked on medical device cybersecurity from a regulatory perspective.

Key Responsibilities

• Provide specialist Regulatory Affairs input across medical device software and cybersecurity
• Review and assess cybersecurity aspects of medical device products and associated documentation
• Provide regulatory guidance throughout the product lifecycle
• Assess regulatory requirements relating to software and cybersecurity
• Support regulatory submissions and technical documentation where required
• Review existing processes, documentation and evidence against applicable regulatory expectations
• Identify regulatory gaps, risks and areas requiring remediation
• Advise on appropriate regulatory strategy for software and cybersecurity related requirements
• Work closely with Software, Engineering, Quality and Regulatory teams
• Provide independent specialist advice and challenge where required
• Support the business in ensuring cybersecurity activities are appropriately reflected within the regulatory framework

About You

We are looking for a Regulatory Affairs professional with substantial medical device software and cybersecurity experience.

Essential experience:

• Strong Regulatory Affairs experience within the medical device industry
• Significant, repeated experience with medical device software
• Significant, repeated experience with cybersecurity from a regulatory perspective
• Strong understanding of regulatory requirements relating to software enabled and/or connected medical devices
• Experience translating cybersecurity requirements into regulatory documentation and compliance activities
• Experience supporting regulatory submissions involving software and cybersecurity
• Strong understanding of applicable medical device cybersecurity guidance, standards and regulatory expectations
• Ability to independently assess regulatory gaps and provide practical recommendations
• Comfortable working autonomously with technical and cross functional teams

Particularly valuable:

• Experience with FDA cybersecurity requirements
• Experience with EU MDR / IVDR
• Experience with IEC 62304
• Experience with IEC 81001-5-1
• Experience with ISO 14971 and cybersecurity risk management
• Experience with threat modelling and cybersecurity risk assessments from a regulatory perspective
• Experience with connected, networked or software driven medical devices
• Previous consultancy experience

The Ideal Consultant

The ideal candidate will not simply be a cybersecurity professional who has worked alongside Regulatory Affairs.

We need someone who has personally and repeatedly dealt with the regulatory implications of medical device software and cybersecurity - someone who understands what regulators expect, what evidence needs to be generated, how it should be documented and where organisations commonly fall short.

You will be comfortable operating independently, challenging existing approaches and bringing specialist knowledge that adds genuine capability beyond the client's existing in house expertise.

Contract Details Location: Fully Remote - UK Duration: Contract Start: ASAP Sector: Medical Devices Focus: Regulatory Affairs Software Cybersecurity Medical Devices Working Style: Independent Consultancy

This is an excellent opportunity for a senior Cybersecurity Regulatory Affairs Consultant to provide specialist expertise to a growing medical device business, with the potential for further consultancy work beyond the initial engagement.