The Company
Our mission at Smartbox is to ensure no one is left without a voice. We create assistive technology for disabled people who experience difficulty with speech, to communicate and live more independent lives. A big part of our culture is our passion, which drives us to continuously improve our products, services and ways of working, so the people who use our technology can achieve their ambitions.
Based in the UK, US, France, Germany and the Netherlands, with partners in over 40 countries, we are a leading supplier in the global augmentative and alternative communication (AAC) community. We don’t take this for granted, and every person in our team is key to ensuring more people who would benefit from assistive technology can access it.
The Job
Smartbox requires an experienced and detail-oriented Regulatory Affairs Specialist (or Lead, depending on experience) to join our growing team. In this role, you will take ownership of ensuring compliance with applicable regulatory requirements for our portfolio of Class I medical devices and Software as a Medical Device (SaMD) products.
You will serve as the key point of contact for regulatory compliance, working closely with internal hardware and software engineering teams, quality assurance, and other regulatory professionals across our group of companies. You will play a critical role in supporting product development and market access by identifying relevant regulations, applying harmonized standards, compiling technical documentation, and leading the declaration of conformity process.
Key Responsibilities and Duties
• Regulatory Strategy & Compliance
o Develop and execute regulatory strategies to support the commercialization of Class I medical devices and SaMD in global markets (UK, EU, US, and others).
o Monitor and interpret relevant regulations, standards, and guidance (e.g., UK MDR, EU MDR, FDA 21 CFR, FCC, RoHS, REACH) and communicate implications to internal stakeholders.
o Conduct gap analyses and lead conformity assessment activities for both CE marking and US market entry.
• Documentation & Submissions
o Prepare and maintain regulatory submissions and documentation including Declarations of Conformity, Technical Files and labelling reviews.
o Ensure documentation is in compliance with ISO 13485, IEC 62304, ISO 14971, and other applicable standards.
• Risk Management
o Lead and coordinate risk management activities in accordance with ISO 14971, integrating risk assessments throughout the product development and post-market phases.
o Ensure traceability of risk control measures to design inputs, verification/validation activities, and clinical evaluations where applicable.
• Cross-Functional Collaboration
o Work with product development and new product introduction teams to embed regulatory requirements throughout the product lifecycle.
o Liaise with quality, clinical, and risk management teams to support product registrations and compliance efforts.
• Product Lifecycle Support
o Provide regulatory input for design changes, software updates, and post-market surveillance activities.
o Support vigilance and reporting activities in coordination with Quality/Clinical teams.
• External Communication
o Serve as a regulatory representative during audits and inspections.
o Communicate with notified bodies, competent authorities, and other regulatory agencies as needed.
The successful applicant will also be asked to perform other duties on an ad-hoc basis and will need a proactive attitude to this.
Essential skills/attributes
· Bachelor’s degree in a scientific, engineering, or regulatory discipline
Minimum 5 years of experience in Regulatory Affairs for medical devices, including software.
· A passion for improving lives through assistive technology
· Strong working knowledge of UK MDR, EU MDR, and FDA medical device regulations.
· Familiarity with technical standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series.
· Experience with Class I medical devices and SaMD regulatory requirements.
· Excellent documentation and communication skills – able to communicate clearly and concisely in spoken and written English.
· A collaborative approach - competent in understanding how teams work and supporting them to build regulatory excellence into their processes
Useful skills/attributes
• Regulatory Affairs Certification (RAC) or equivalent
• Ability to manage
• Experience interacting with regulatory bodies (MHRA, FDA, Notified Bodies)
Additional Information
• In this role, you will have the flexibility to work between your home and our office locations in Malvern and Bristol. For this role, we require the candidate to work in the Bristol office twice a week as a minimum.
• You will need to maintain a deep understanding and knowledge of all our products and their uses.
• You will meet and keep in regular contact with other teams in the business.
Rewards and benefits
Smartbox offers comprehensive benefits including:
• Company Pension.
• Group Life Assurance.
• Income Protection.
• Private Medical Insurance.
• 25 days holiday plus public holidays.
• Onsite parking in Bristol
• Flexible working.
• Cycle scheme.
• Office snacks.
• Benefit and Wellbeing app Yulife, with store discounts and wellbeing services available.
• Annual Charity Day.
• Long Service Award.
• Training and development opportunities.
• Complimentary theatre and cinema tickets to Malvern Theatres.
• EV car scheme through salary sacrifice after 2 years’ service.
• Corporate gym membership discount.
• We are passionate about our people and offer many social events including team outings and get-togethers.
How to apply
We welcome applications from all communities and those from diverse backgrounds and groups. Please outline your experience and ability to excel in this role within your cover letter.
Diversity and Inclusion
We are proud to be a Disability Confident Employer and one of the sponsors for Purple Tuesday- the #1 brand working to improve the experiences of disabled people as customers 365 days a year. We are fully committed to the employment and career development of disabled people. To ensure everyone has an equal chance, we’re always willing to make reasonable adjustments to the recruitment process. Should you require further assistance or require any reasonable adjustments to be put in place to better support your application process, please do not hesitate to contact us via email: jobs@thinksmartbox.com or call 01684213075.
Corporate responsibility
At our company, we are driven by a passion for making a positive impact on society, minimizing our environmental footprint, and meeting the needs of our stakeholders. We have been actively working towards becoming B-Corp certified, aligning ourselves with a global movement dedicated to eradicating poverty, protecting the planet, and fostering lasting prosperity for all. To learn more about our commitment to sustainability, please visit this link: Corporate Responsibility and Sustainability.