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Medical Device Assessors
1 week ago
DNV London, United Kingdom**About us**: · We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with co ...
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Medical Device Assessors
6 days ago
DNV London, United Kingdom**About us**: · We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with co ...
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Medical Device Quality Intern
5 days ago
Entia Ltd London, United KingdomMEDICAL DEVICE QUALITY INTERN · Entia Ltd, Lloyds Avenue, London, UK · 3 month contract, Full Time · Entia is building a world where we live long and healthier lives because cancer care is personalised to us. · We're an oncology services company supporting the delivery of more ef ...
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Solutions Consultant Medical Devices
1 week ago
Noblesse Recruitment London, United KingdomCompany Description · The company is one of the global leaders in the market. They manufactures, markets and distributes high quality and high-tech products in over 90 countries worldwide. A dynamic and innovative organization in the Medical Devices industry. · **Job Description* ...
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Medical Devices
5 days ago
Newton Colmore Consulting Ltd United KingdomMedical Devices – Senior Mechanical Design Engineer – Cambridge · Medical Devices – Senior Mechanical Design Engineer – Cambridge · Due to successful growth plans, a Medical Devices organization based in Cambridge is currently seeking a Senior Mechanical Design Engineer to cont ...
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Medical Devices Engineer
2 days ago
Hodfin Kingston Upon Thames, United Kingdom**Job Title** - Field Service Engineer - Medical Devices · **Location** - Kingston upon Thames · **Salary** - up to £37k Basic + 10% bonus + benefits below / £50k OTE · **Company** · Our client is a leading Manufacturer of medical instruments and services. Working with the NHS & ...
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Medical Devices Engineer
1 week ago
Hodfin Harrow, United Kingdom**Job Title** - Field Service Engineer - Medical · **Location** - Harrow / Wembley / Watford · **Salary** - up to £37k Basic / £50k OTE + benefits below · **Company** · Our client is a leading Manufacturer of medical devices and services. Working with the NHS and Private Healthca ...
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Medical Devices Engineer
2 days ago
Hodfin Enfield, United Kingdom**Job Title** - Field Service Engineer - Medical Devices · **Location** - Enfield · **Salary** - up to £37k Basic + 10% bonus + benefits below / £50k OTE · **Company** · Our client is a leading Manufacturer of medical instruments and services. Working with the NHS & Private Secto ...
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Medical Devices Engineer
1 week ago
Hodfin Orpington, United Kingdom**Job Title** - Field Service Engineer - Medical · **Location** - Orpington · **Salary** - up to £37k Basic / £50k OTE + benefits below · **Company** · Our client is a leading Manufacturer of medical devices and services. Working with the NHS and Private Healthcare, they are very ...
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Medical Devices Administrator
1 week ago
Hertfordshire Community NHS Trust Hatfield, United KingdomThe post holder will provide comprehensive administrative support to the Medical Devices Team, undertaking a wide range of administrative tasks. This will include being a focal point of contact for HCT staff regarding the servicing and repair of medical equipment Hertfordshire Co ...
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Medical Devices Engineer
2 days ago
Hodfin Watford, United Kingdom**Job Title** - Field Service Engineer - Medical Devices · **Location** - Watford · **Salary** - up to £37k Basic + 10% bonus + benefits below / £50k OTE · **Company** · Our client is a leading Manufacturer of medical instruments and services. Working with the NHS & Private Secto ...
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Medical Devices Administrator
2 days ago
Hertfordshire Community NHS Trust Hatfield, United KingdomHertfordshire Community NHS Trust (HCT) is a dynamic and forward-thinking organisation. Our Trust is one of a new generation of community health service Trusts in the NHS. We are responsible for delivering a wide range of community health services across Hertfordshire. Our servic ...
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Medical Device Assessors
1 week ago
DNV Germany Holding GmbH United KingdomAboutSCPA · We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing ...
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Medical Devices Consultant
1 week ago
Newton Colmore Consulting Ltd United KingdomMedical Devices Consultant – Senior Mechanical Engineer – Cambridge · Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approv ...
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Medical Devices Technologist
2 weeks ago
Torbay and South Devon NHS Foundation Trust England, United KingdomMain area Medical Devices Management/ Clinical Engineering - 'Electronics, Electrical, Mechanical Engineer' Grade NHS AfC: Band 5 Contract Permanent Hours Full time hours per week (Services runs 7 days a week) Job ref E&A-A · Site Torbay Hospital Town Torquay Salary £28,407 - £3 ...
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Medical Devices Consultant
5 days ago
Newton Colmore Consulting Ltd United KingdomMedical Devices Consultant – Senior Mechanical Engineer – Cambridge · Due to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approv ...
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Medical Device Engineer
1 week ago
Lewisham and Greenwich NHS Trust London, United Kingdom Part timeDo you work as a Clinical Engineer in a field involving medical devices within the NHS? · Do you enjoy working in a healthcare environment with opportunities to interact with clinical staff and fellow colleagues, and making an impact on how medical devices are managed? · If so, a ...
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Director Medical Device
1 week ago
Pharma Search London, United KingdomDo you have a strong clinical operations background, coupled to commercial expertise and excellent communication skills? · You will be responsible for leading a customer focused franchise, consisting of medical and operational staff with significant subject matter expertise. You ...
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Medical Devices Administrator
1 week ago
Hertfordshire Community NHS Trust Hatfield, United KingdomWhilst it is not a legal requirement, Hertfordshire Community NHS Trust encourages and supports all staff to be vaccinated as this remains the best line of defence against COVID-19. We are committed to supporting flexible working options for staff, wherever possible, and welcome ...
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Medical Device Decontamination Technician
1 week ago
Ramsay Health Care Watford, United Kingdom**Decontamination Technician Supervisor** · We are looking for a dynamic people person with excellent organisational skills. You will know your way around the decontamination of re-usable medical devices and you will have had experience of ISO standard quality systems. You will h ...
Regulatory Affairs Medical Device - England, United Kingdom - Discover International
Description
As the Head of Regulatory Affairs for the United Kingdom and Ireland, you will be responsible for leading and managing all regulatory activities to ensure compliance with applicable laws, regulations, and guidelines governing our organization's products and operations within these regions.
This role requires a deep understanding of regulatory requirements in both the UK and Ireland, excellent leadership skills, and the ability to collaborate effectively across departments and with regulatory agencies in both countries.
Regulatory Strategy Development:
Develop and implement regulatory strategies aligned with business objectives for products in the UK and Ireland markets. Stay informed about changes in regulatory requirements and proactively adjust strategies as needed.
# Regulatory Compliance:
Ensure that all products, processes, and activities comply with relevant UK and Irish regulations, standards, and guidelines. Monitor regulatory developments and assess their impact on the organization.
# Regulatory Submissions:
Oversee the preparation, submission, and maintenance of regulatory submissions to UK and Irish regulatory authorities, including marketing authorization applications, variations, and renewals.
# Regulatory Intelligence:Stay abreast of regulatory trends, competitor activities, and industry best practices in the UK and Irish regulatory landscapes. Use this intelligence to inform decision-making and provide strategic guidance to senior management.
# Cross-Functional Collaboration:
Collaborate closely with internal stakeholders, including R&D, Quality Assurance, Legal, and Commercial teams, to ensure regulatory requirements are considered throughout the product lifecycle.
# Serve as the primary point of contact for interactions with UK and Irish regulatory agencies. Represent the organization in meetings, negotiations, and communications with regulatory authorities.# Risk Management:
Identify regulatory risks and develop mitigation strategies to address them. Provide guidance on risk assessment and management to ensure compliance and minimize regulatory issues.
# Training and Development:
Provide leadership, guidance, and mentorship to regulatory affairs team members. Conduct training sessions to ensure awareness of regulatory requirements and foster a culture of compliance within the organization.
# Quality Management Systems:
Collaborate with Quality Assurance to maintain and improve the organization's quality management systems, ensuring alignment with regulatory requirements and industry standards.
# Prepare the organization for regulatory inspections and audits conducted by UK and Irish regulatory authorities. Bachelor's degree in a scientific discipline; Extensive experience (10+ years) in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on the UK and Irish markets.Demonstrated expertise in UK and Irish regulatory requirements and processes, including experience with MHRA and HPRA submissions and interactions.
Strong leadership skills with experience managing teams and leading cross-functional projects.Strategic thinking and problem-solving abilities, with a proactive approach to regulatory challenges.
Familiarity with quality management systems and regulatory compliance frameworks (e.g.,