Regulatory Affairs Specialist

About Us

Aesthetic Technology Ltd, the company behind Dermalux LED, is a British manufacturer specialising in advanced light-based technologies for the medical, aesthetic and cosmetic markets. From concept to finished product, Dermalux systems are designed, developed and manufactured in the UK to the highest standards of quality, safety and compliance. As an ISO 13485-certified medical device manufacturer, we have been a leader in non-invasive energy-based treatments since 2012 and are a trusted brand in professional LED phototherapy.

The Dermalux portfolio features our proprietary Tri-Wave LED technology, with clinically proven wavelengths and treatment protocols tailored to a range of skin conditions. Our devices are used by professionals worldwide as both standalone and combination treatments to improve skin health and client outcomes.

The Role

We are looking for a Regulatory Affairs Specialist to join our small, close-knit Regulatory team in Warrington. This is a full-time hybrid role reporting to the Regulatory Affairs Lead.

You will help Dermalux obtain and maintain market access for its medical device portfolio across the UK and international markets. The role covers technical documentation, regulatory submissions and registrations, change and labelling assessments, and post-market activities including complaint and vigilance assessments. You will get broad exposure across the full regulatory lifecycle.

Key Responsibilities

• Prepare, compile and maintain audit-ready Technical Documentation, including GSPR checklists and the applicable standards register
• Support regulatory submissions to UK and global authorities, and coordinate international registrations and renewals with distributors and in-country representatives
• Assess the regulatory impact of product, labelling and process changes through Change Control
• Review and approve labelling, IFUs and marketing materials to ensure claims are compliant
• Support Clinical Evaluation Reports (CERs) and Post-Market Surveillance activities, including PSURs and PMCF
• Complete complaint decision trees, regulatory assessments and adverse event reportability assessments
• Support vigilance reporting to Competent Authorities within regulatory timeframes
• Contribute to risk management activities in line with ISO 14971
• Manage device registrations and UDI data within EUDAMED and other applicable databases
• Provide regulatory input and strategy to new product development and design change projects
• Monitor changes to medical device legislation, standards and guidance, and communicate their impact
• Support internal and external audits, including Notified Body assessments and Competent Authority inspections
• Author and maintain regulatory procedures and work instructions within the QMS

What We’re Looking For

Essential:

• Proven experience in a regulatory affairs or quality role within the medical device industry
• Sound working knowledge of EU MDR 2017/745, UK MDR 2002 (as amended), ISO 13485:2016 and MDCG guidance
• Experience preparing technical documentation and regulatory submissions
• Experience completing regulatory and adverse event reportability assessments
• Familiarity with ISO 14971 risk management principles
• Experience working within an ISO 13485-certified QMS, including CAPA and change control
• Strong attention to detail, with the ability to manage multiple priorities and meet regulatory deadlines
• Excellent written and verbal communication skills, and the ability to work cross-functionally with internal teams and external stakeholders
• Flexibility to take on a varied workload. As part of a small department, you may be asked to support tasks beyond those listed here, so the responsibilities above are not exhaustive.

Desirable:

• Familiarity with the IEC 60601 family of standards
• Experience supporting Notified Body audits or regulatory inspections
• Experience with light-based or energy-based devices in the aesthetic or medical sector