- Regulatory Compliance: Ensure that all products comply with local, national, and international regulations, including CE, MDR, FDA, FCC, RoHS, REACH, and other industry-specific standards.
- Documentation and Certification: Prepare and maintain all necessary documentation for product compliance, including test reports, declarations of conformity, and technical files. Liaise with third-party certification bodies as needed.
- Risk Management: Identify potential compliance risks throughout the product lifecycle and develop strategies to mitigate these risks.
- Testing and Validation: Oversee and coordinate product testing to ensure compliance with applicable standards. Work closely with internal and external laboratories to validate test results.
- Cross-functional Collaboration: Collaborate with engineering, design, manufacturing, and legal teams to integrate compliance requirements into product development and manufacturing processes.
- Standards Development and Monitoring: Stay updated on changes to relevant regulations and standards. Participate in industry forums and standards development organisations.
- Training and Guidance: Provide compliance training and guidance to internal teams, ensuring that all stakeholders understand and adhere to regulatory requirements.
- Continuous Improvement: Lead initiatives to continuously improve compliance processes and systems within the organisation.
- Technical Proficiency in Electrical Safety, EMC, and Environmental.
- Degree or equivalent experience in an engineering discipline.
- 4+ years' experience in product compliance or regulatory affairs.
- A creative entrepreneurial attitude.
- Infusing enthusiasm and a positive attitude into your work.
- Expertise in Regulatory Process.
- Proficiency in Quality Management Systems.
- Effective Communication at All Levels: Demonstrating the ability to communicate clearly and persuasively across various organisational levels, facilitating effective collaboration and understanding.
- 8D/CAPA.
- High Level of Technical Skills.
- Analytical Thinker: Demonstrating strong analytical thinking capabilities, enabling the navigation of complex risk determinations and the formulation of informed decisions based on critical analysis.
- Attention to Detail: Displaying a keen eye for detail and meticulousness in work, ensuring accuracy and precision in tasks and deliverables.
- Self-Starter.
- Excellent Collaborative Skills.
- Meticulous Organisation.
- Strong Project Management Skills: Possessing the ability to manage multiple projects simultaneously, ensuring timely delivery, effective resource allocation, and successful project outcomes.
- Global Perspective.
- Experience in a medical device company
- ISO 9001
- ISO 13485
- ISO
- ISO 14971
- EU MDR
- FDA Medical Devices
-
Service Assurance Manager
1 week ago
BT Group Bristol, United KingdomWhat you'll be doing · Lead the creation and transformation of the Mobile quality assurance & delivery framework providing clear recommendations and options to meet business objectives. · Lead the development and implementation of the Mobile QA tools strategy, ensuring alignm ...
-
Security Assurance Manager
1 week ago
Datasource Bristol, United KingdomIntroduction · Our client is looking for an experienced Security professional to manage security risks for a Defence engineering department. The ideal candidate will have worked in a Defence or Nuclear organisation before and provided security assurance for IT, Engineering and B ...
-
Security Assurance Manager
3 weeks ago
The Engineer Bristol, United Kingdom £70,000Bristol · Do you want to be the lead in a crucial and exciting role within in our Security team? · Job Title : Security Assurance Manager (Export) · Salary : Circa £70,000 depending on experience · Location : Stevenage, Bristol or Bolton (We may be able to offer a relocation ...
-
Quality Assurance Manager/iro
3 weeks ago
RT Social Care Hallen, United KingdomRT- Social care are working with South Gloucestershire council · - Paying £41 per hour · This is a part time 3 days per week post only hours) · We are looking for someone who is a qualified social worker and has the following experience: · - Mangerial experience · - Chairing Chil ...
-
Compliance and Quality Assurance Manager
2 weeks ago
GET STAFFED ONLINE RECRUITMENT LIMITED Bristol, United Kingdom Full timeCompliance and Quality Assurance Manager · Our client is a trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join their product development team and report to the Head of ...
-
Cyber Security Assurance Manager
1 week ago
Akkodis Bristol, United KingdomJob Description · Security Assurance Manager · Locations: Bristol or Stevenage · An advanced organization is in a phase of growth and is actively seeking a Security Assurance Manager to oversee Security Strategy, Policies, Customer Security Policies, and ensure compliance with al ...
-
Cyber Security Assurance Manager
6 days ago
Akkodis Bristol, United Kingdom Full timeCyber Security Assurance ManagerLocations: BristolAn advanced organisation is in a phase of growth and is actively seeking a Security Assurance Manager to oversee Security Strategy, Policies, Customer Security Policies, and ensure compliance with all applicable laws and regulatio ...
-
Programme Manager Life Assurance
1 week ago
Datasource Recruitment Bristol, United KingdomOur large consulting client is looking for a Space SME, with excellent connections within Space/Defence industry, to lead programmes and projects within the space sector. · You will need to have experience leading teams, ensuring delivery, account management and business develop ...
-
Cyber Security Assurance Manager
3 weeks ago
Akkodis Bristol, United KingdomJob Description · Cyber Security Assurance Manager · Locations: Bristol · An advanced organisation is in a phase of growth and is actively seeking a Security Assurance Manager to oversee Security Strategy, Policies, Customer Security Policies, and ensure compliance with all appli ...
-
Compliance and Quality Assurance Manager
3 weeks ago
Smartbox Assistive Technology Bristol, United KingdomCompliance and Quality Assurance Manager · Our trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join our product development team and report to the Head of Hardware. At S ...
-
Test Manager in Quality Assurance
2 weeks ago
Procentia Bristol, United Kingdom £80,000Group Head of QA and Testing - Pension Software - Bristol · Emersons Green (Hybrid working) · Salary: Up to £80,000 + bonus + benefits · No agencies · You're crucial to unlocking the potential of our market leading software (as voted for by our Clients - UK's no.1 pensions admin ...
-
Lloyds Banking Group Bristol, United Kingdom Full timeDescription · About this Opportunity · If you think all banks are the same, you'd be wrong. We're an innovative, fast-changing business that's shaping finance as a force for good. A bank that's empowering its people to innovate, explore possibilities and grow with purpose. · Wi ...
-
Quality Assurance Manager
3 weeks ago
Hunter Selection Hengoed, United KingdomQA Manager · Hengoed CF82 · Commutable from Blackwood, Caerphilly, Newport, Heads of the Valleys, Merthyr Tydfil, Aberdare, Abertillery, Cardiff, Pontypridd · £45,000 · Benefits · 25 days holiday + Bank Holidays · 5% Bonus · Company Pension - 6% employer, 3% employee · Training ...
-
Supply Chain Quality Assurance Manager
3 days ago
iO Associates - UK/EU Bristol, United Kingdom £35Job Description Title: Supply Chain and Quality Manager · Location: Filton, Bristol (HYBRID) · Pay rate: £35 per hour, inside IR35. · An innovative company at the forefront of the aerospace industry, located in Filton is actively seeking a Supply Chain and Quality Manager to jo ...
-
Quality Assurance Manager
3 weeks ago
TristoneNash Ltd Cardiff, United KingdomTristoneNash are pleased to be supporting a women's equality organisation which exists to eradicate violence against women and girls and to support survivors, to appoint a Quality Assurance Manager. · **Overview**: · Working closely with the Service Manager, you will maintain exc ...
-
Security Assurance Manager
4 weeks ago
MBDA Bristol, United Kingdom Full timeBristol · Do you want to be the lead in a crucial and exciting role within in our Security team? · Job Title: Security Assurance Manager (Export) · Salary: Circa £70,000 depending on experience · Location: Stevenage, Bristol or Bolton (We may be able to offer a relocation packag ...
-
Quality Assurance Manager
2 weeks ago
Akkodis Bristol, United Kingdom**Quality Manager** · **Homebased Position with occasinal visitis to Office, locations in Bristol/London/Stevenage** · An exciting position has opened up for our internal Quality Management team. With a shared passion for technology and talent, 50,000 engineers and digital expert ...
-
Supply Chain Quality Assurance Manager
4 days ago
iO Associates - UK/EU Filton, Gloucestershire, United Kingdom £35Title: Supply Chain and Quality Manager · Location: Filton, Bristol (HYBRID) · Pay rate: £35 per hour, inside IR35. · An innovative company at the forefront of the aerospace industry, located in Filton is actively seeking a Supply Chain and Quality Manager to join its engineer ...
-
Datasource Bristol, United KingdomCost & Supply Chain Assurance Consultant Management Consultant (Supply Chain & Cost Management) · Introduction · My client is a Consultancy company who advise and manage client projects. They get deeply involved in the clients commercial management departments in providing Cost ...
-
Datasource Bristol, United KingdomCost & Supply Chain Assurance Consultant Management Consultant (Supply Chain & Cost Management) · My client is a Consultancy company who advise and manage client projects. They get deeply involved in the clients commercial management departments in providing Cost Assurance servic ...
Compliance and Quality Assurance Manager - Bristol, United Kingdom - Smartbox Assistive Technology
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Compliance and Quality Assurance Manager
Our trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join our product development team and report to the Head of Hardware. At Smartbox, our cutting-edge technology gives a voice to those with limited speech, positively impacting the lives of people with disabilities worldwide. As a Compliance and Quality Assurance Manager, you will be a driving force for quality in the development team. You will upgrade our team, systems and processes using innovative methodologies.
Your expertise in product compliance or regulatory affairs will be key to our continued success. All around the world, our products, accomplishments and aspirations are a reflection of our teams' values: passionate, caring, empowering, achieving together and enabling change.
This is a hybrid role based in Bristol, with the requirement to come into the office twice a week. The salary for this position will be determined based on the applicant's education, skills and experience.
How will you be making a difference
Essential Qualifications/skills/experience
Useful Qualifications/skills/experience
Why join us
Here at Smartbox, we are positive and inclusive about making adjustments, providing flexible working, and encouraging all staff to engage in a diverse range of year-round learning and personal development opportunities. In addition, you will work alongside highly motivated colleagues in an environment of strong teamwork whilst also having fun. This is a hugely rewarding role and a career to be proud of where every day you will go home knowing you made a positive difference in the lives of disabled people.
Rewards and benefits
At Smartbox our employees always do their best, which is why we give so much in return. In addition to your competitive salary, private medical insurance, and a whooping 25 days of holiday plus public holidays, we'll shower you with perks, including:
Dress: We want you to feel comfortable in the office; smart casual is perfect.Food: You can find free healthy office snacks in our kitchens.Hybrid working: Laptop and home working IT kit provided.Flexible work schedule: Balance is key to innovation, and we want to make sure you are at the top of your game with a schedule that will work for you (prior agreement from your line manager is required).Give back to the community: Each year every member of staff will get the opportunity to spend one paid day volunteering for a good cause of their choice.You, our best asset: We believe in investing in you and your development. Stay with us and grow with us We will reward you with more holidays for your long serviceWellness: Stretch away the stress every morning with our online trainers, available via our cooperative perk website or hit the gym. We provide gym discounts tooWellbeing: You gain unlimited access to a benefit and Wellbeing app Yulife,providing store discounts and wellbeing services.Mental health: You will have access to the 24/7 Employee Assistance Programme for a wide range of support, advice and resources about Family, Health, Life, Money