Regulatory Affairs Specialist/Lead

Smartbox Assistive Technology; Bristol; Hybrid; GBP 50,000 - 75,000; Full time

Job summary

Smartbox Assistive Technology seeks a dedicated Regulatory Affairs Specialist/Lead to join their team. As part of a passionate group, you will leverage your expertise in regulatory strategies and compliance to support the commercialisation of medical devices. This role involves close collaboration with product teams, ensuring adherence to crucial regulatory standards across global markets. Your impact will enhance lives through our innovative technology solutions, contributing to an inclusive and sustainable future.

Benefits

Private medical insurance

Paid volunteering days

Wellness benefits

Hybrid working model

Qualifications

• Minimum 5 years of experience in Regulatory Affairs for medical devices.
• Strong understanding of UK MDR and EU MDR.
• Experience with Class I medical devices and SaMD regulatory requirements.

Responsibilities

• Develop and execute regulatory strategies for medical devices.
• Prepare and maintain regulatory submissions and documentation.
• Lead risk management activities in product development.

Skills

Regulatory Strategy Development

Documentation and Compliance

Risk Management

Cross-Functional Collaboration

Communication Skills

Education

Bachelor's Degree in a Scientific or Regulatory Discipline

Tools

ISO 13485

IEC 62304

FDA Regulations

Job description

Join us at Smartbox as a Regulatory Affairs Specialist/Lead.

Are you a passionate Regulatory Affairs Specialist/Lead looking to make a real impact by giving a voice to those without speech Smartbox is looking for an experienced and detail-oriented Regulatory Affairs Specialist (or Lead, depending on experience) to join our growing team.

Your Impact

As our Regulatory Affairs Specialist/Lead, you will:

Regulatory Strategy & Compliance:

• Develop and execute regulatory strategies to support the commercialisation of Class I medical devices and SaMD in global markets (UK, EU, US, and others).
• 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.
• Conduct gap analyses and lead conformity assessment activities for both CE marking and US market entry.

Documentation & Submissions:

• Prepare and maintain regulatory submissions and documentation including Declarations of Conformity, Technical Files and labelling reviews.
• Ensure documentation is in compliance with ISO 13485, IEC 62304, ISO 14971, and other applicable standards.

Risk Management:

• Lead and coordinate risk management activities in accordance with ISO 14971, integrating risk assessments throughout the product development and post-market phases.
• Ensure traceability of risk control measures to design inputs, verification/validation activities, and clinical evaluations where applicable.

Cross-Functional Collaboration:

• Work with product development and new product introduction teams to embed regulatory requirements throughout the product lifecycle.
• Liaise with quality, clinical, and risk management teams to support product registrations and compliance efforts.

Product Lifecycle Support:

• Provide regulatory input for design changes, software updates, and post-market surveillance activities.
• Support vigilance and reporting activities in coordination with Quality/Clinical teams.

External Communication:

• Serve as a regulatory representative during audits and inspections.
• Communicate with notified bodies, competent authorities, and other regulatory agencies as needed.

Essential Qualifications/Skills/Experience:

• 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.

About Smartbox

At Smartbox, we're proud to be at the forefront of assistive communication technology. Our innovative products are used globally by individuals with diverse needs. Our values - passionate, caring, empowering, achieving together, and enabling change - resonate in everything we do.

Our Inclusive Culture

We believe in giving everyone a voice. Joining Smartbox means joining a diverse team that values collaboration and supports a community that relies on our technology for effective communication.

Our Commitment to Sustainability

At Smartbox, we not only innovate but also prioritise sustainability. We aim to minimise our carbon footprint and promote a greener world through sustainable solutions. By joining us, you'll contribute to shaping a more inclusive society while actively supporting our sustainability efforts.

Our D&I Commitments

At Smartbox, we prioritise diversity and inclusivity in our work environment. Here's how we do it:

• Recognised as a Disability Confident Employer by the UK Government and Founding Partner of Purple Tuesday.
• Our recruitment practices are inclusive and barrier-free, with adjustments available during the application process and throughout your career with us.
• We believe in adding to our culture, not just fitting in. Our diverse team combines unique talents to create products that reflect the diversity of our users and customers.

Rewards and Benefits

Discover a world of rewards and benefits tailored to your wellbeing at Smartbox. Beyond a competitive salary and private medical insurance, explore perks like a hybrid working model, wellness benefits, and paid volunteering days.

Ready to Make a Difference

Join us at Smartbox and embark on a fulfilling career where your work truly matters. Apply now and be a part of a team dedicated to creating technology that changes lives.

Agencies

Please respect that at this current time, we wish to try and recruit directly from the market rather than engage support from an agency.