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For Companies At a Glance
- Tasks: Develop regulatory strategies and ensure compliance for innovative medical devices.
- Company: Smartbox leads in assistive communication technology, empowering individuals globally.
- Benefits: Enjoy hybrid working, wellness perks, and paid volunteering days.
- Why this job: Make a real impact by improving lives through technology in a supportive, inclusive culture.
- Qualifications: Bachelor's degree and 5 years in Regulatory Affairs for medical devices required.
- Other info: Join a diverse team committed to sustainability and inclusivity.
The predicted salary is between 36000 - 60000 £ per year.
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
- 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.
Regulatory Affairs Specialist/Lead in Bristol employer: Smartbox Assistive Technology
Contact Detail:
Smartbox Assistive Technology Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist/Lead in Bristol
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as UK MDR, EU MDR, and FDA 21 CFR. This knowledge will not only help you during interviews but also demonstrate your commitment to understanding the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with medical devices and software. Engaging with industry groups or attending relevant conferences can provide valuable insights and connections that may help you stand out.
✨Tip Number 3
Prepare to discuss your previous experiences in regulatory affairs, particularly any specific projects involving Class I medical devices or SaMD. Be ready to share examples of how you've successfully navigated compliance challenges or contributed to product lifecycle support.
✨Tip Number 4
Showcase your collaborative skills by thinking of examples where you've worked cross-functionally with teams like quality, clinical, or risk management. Highlighting your ability to work well with others will align with Smartbox's values and culture.
We think you need these skills to ace Regulatory Affairs Specialist/Lead in Bristol
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly with medical devices and software. Emphasise your knowledge of UK MDR, EU MDR, and FDA regulations, as well as any specific projects you've worked on that align with the job description.
Craft a Compelling Cover Letter: In your cover letter, express your passion for assistive technology and how it aligns with Smartbox's mission. Mention specific examples of how you've contributed to regulatory strategy and compliance in previous roles, showcasing your ability to make an impact.
Highlight Cross-Functional Collaboration: Since the role involves working with various teams, include examples in your application that demonstrate your collaborative approach. Discuss how you've successfully liaised with product development, quality, and clinical teams to ensure regulatory compliance.
Showcase Your Communication Skills: Given the importance of clear communication in this role, provide examples of how you've effectively communicated complex regulatory information to stakeholders. This could be through documentation, presentations, or during audits and inspections.
How to prepare for a job interview at Smartbox Assistive Technology
✨Know Your Regulations
Familiarise yourself with the key regulations and standards relevant to the role, such as UK MDR, EU MDR, and FDA 21 CFR. Be prepared to discuss how you have applied these in your previous roles.
✨Showcase Your Documentation Skills
Prepare examples of regulatory submissions and documentation you've worked on, like Technical Files or Declarations of Conformity. Highlight your attention to detail and ability to maintain compliance with ISO standards.
✨Demonstrate Cross-Functional Collaboration
Be ready to share experiences where you've worked with product development, quality, and clinical teams. Emphasise your collaborative approach and how it has led to successful regulatory outcomes.
✨Express Your Passion for Assistive Technology
Convey your enthusiasm for improving lives through technology. Share any personal stories or motivations that drive your interest in assistive communication solutions, aligning with Smartbox's mission.
