Director of quality assurance Work, Jobs in London, Eng (with Salaries)

Head of Quality Assurance and Regulatory Affairs
Inspiration Healthcare Ltd —Croydon
- Full-time
- Hybrid work
- Team management
- Leadership
- Communication skills
Quick apply
13d
Director, Clinical Quality Assurance
BioNTech AG —London
- £168,100 - £268,700 a year
- Full-time
- Bachelor's degree
- Team management
- Leadership
Head of Quality
Kane Group —London
- Full-time
- Computer literacy
- Engineering
- Bachelor's degree
- Annual leave
- Employee assistance programme
Quick apply
Head of Assessment & Quality
The King's Trust —London
- £53,393 - £65,000 a year
- Full-time
- Continuous improvement
- Leadership
- Annual leave
- Employee discount
3d
Head of Quality & Partnerships (1FTE, FTC)
Royal College of Art —London
- £64,753 - £72,255 a year
- Full-time
- Management
- Writing skills
- University
10d
Head of Computerized Systems Quality Assurance & Validation
IXICO —London
- Full-time
- Hybrid work
- Machine learning
- AI
- Communication skills
- Annual leave
- Employee assistance programme
Head of Safeguarding and Quality Assurance - Adults
Knowsley Borough Council —Borough Station
- £87,117 - £93,978 a year
- Hybrid work
- Flexible schedule
Head of Quality Engineering
Premium Credit Limited —London
- Hybrid work
- AI
- Annual leave
- Employee assistance programme
Head of Quality Engineering
Moneybox —London
- Quality control
3d
Quality Risk Senior Director/Managing Director (QRM) EMEA Tax
Alvarez and Marsal —London
- Full-time
- Contracts
- Communication skills
- Tax experience
Director QA, GMP External Operations Cell and Genetic Therapies - VCGT
Vertex Pharmaceuticals —Paddington
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
Quality Risk Senior Director/Managing Director (QRM) EMEA Tax
Alvarez & Marsal —London
- Part-time
- Communication skills
- Tax experience
Head of QA and Test Automation
Collinson —London
- Hybrid work
- Hotel
- Quality control
- Mentoring

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Director, Clinical Quality Assurance
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director of quality assurance jobs near london, eng

Head of Quality Assurance and Regulatory Affairs

Inspiration Healthcare Ltd
Croydon

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Job details

Permanent | Full-time
13 days ago

Qualifications

Stakeholder liaison
Internal quality management system auditing
Corrective and preventive actions (CAPA)
Compliance audits
Complaint handling
Compliance management
Quality assurance
Product development
Team management
Quality management system (QMS) implementation
Leadership
Communication skills
Internal quality assurance
ISO 13485
Corporate regulatory compliance oversight
FDA regulations

Full job description

Job Purpose (Role Definition):

The Head of Quality Assurance and Regulatory Affairs:

will manage the Quality Assurance and Regulatory Affairs function.
is appointed as the person responsible for regulatory compliance, ensuring that the business meets the requirements of the MDR.
is appointed by Top Management as the Management Representative.
is responsible for developing, implementing, maintaining and promoting the Quality Assurance and Regulatory Affairs strategy and providing leadership to the Regulatory and Quality Assurance functions.
is responsible for driving a quality and regulatory culture, ensuring that all staff are aware of the policies and procedures and the need to adhere to them.

The position also includes:

maintaining the Quality Management Systems and ensuring compliance with regulatory requirements.
provides leadership to the Quality Assurance and Regulatory Affairs function
responsible for ensuring compliance with MDSAP and other regulations (where applicable)
the position is also responsible for making sure filings are completed in key global territories and supporting our customers' regulatory efforts
takes responsibility for the day-to-day Quality Assurance and Regulatory Affairs activities. In addition, the role is responsible for keeping abreast of all regulatory changes impacting on the business and providing regulatory support to project and development teams across the company

Main Duties and Responsibilities:

Act as Management Representative.
Act as the key liaison with the Authorised Person under the European Union Medical Device Regulation.
Ensuring that processes needed for the Quality Management Systems are documented in accordance with MDSAP and ISO 13485 standard.
Reporting to Chief Executive Officer on the effectiveness of the Quality Management Systems and any needs for improvements.
Ensuring the promotion of awareness of applicable regulatory requirements and Quality Management Systems requirements.
Support the preparation of global regulatory strategies for the registration of new and modified products and to implement the regulatory project plan, including applicable regulatory submission schedule deliverables.
To develop, implement, maintain, and promote Quality Assurance strategy.
Raise awareness and advise on compliance routes to support new product development.
To ensure compliance to all applicable standards, regulations and internal procedures by proactively interpreting Quality and regulatory requirements and devising and implementing solutions to support the maintenance and enhancement of Quality Management Systems and regulatory documentation.
Responsible for communications with customers, notified bodies and other regulatory bodies to address Quality Assurance, Quality Management Systems and Regulatory Affairs issues and accreditations.
Responsible for the overall compliance and delivery of Internal and External Audits, CAPA, Management Review and External Audits.
Liaising with competent authorities and regulatory authorities on issues with patient safety for all products.
Ensuring that Vigilance and PMS processes needed for the Quality Management Systems within the Group are documented in accordance with MDSAP and ISO 13485 standard.
Oversee the Complaint handling activities, ensuring all KPI's are met including complaint investigations and regulatory reporting timelines.
Supporting the promotion of supplier and manufacturing quality awareness of applicable quality requirements and Quality Management System requirements.
Responsible for the CAPA process management.
Oversee the Nonconformity process

Management Responsibilities:

Quality Assurance and Regulatory Affairs team

Experience and Qualifications Required:

Mandatory:

Five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Proven leadership in Quality Assurance and Regulatory Affairs within medical devices.
A demonstrable strong working knowledge and experience of applying medical device standards and regulations within the medical device industry, in particular ISO 60601 series.
Experience in liaising with Notified bodies, Certification Bodies and Competent Authorities.
Experience of development of new products from initial concept to commercialisation.
A track record of developing and executing global regulatory strategies that align with business needs.
Experience managing CE marking and FDA approval processes
Experience and demonstrated performance working with medical device quality management and/or regulatory affairs, in particular software medical device standards
Experience working across different regulatory markets; EU, US and UK and any other relevant markets.
Good knowledge of ISO 13485 and MDSAP
Good knowledge of ISO 60601 series

Desirable:

MDR Certification
Internal Audit Certification

Key Skills and Competencies:

A demonstrable and broad understanding of medical device quality assurance and regulatory affairs.
The ability to interpret regulatory and standard requirements to ensure that implications for users and processes are clear.
The ability to learn quickly and establish a high degree of regulatory and quality knowledge.
The ability to engage and deliver compelling presentations to a varied audience and communicate and present a technical subject matter in an understandable, coherent manner.
The ability to engage, inspire and manage subordinate staff to achieve the same levels of excellence expected of yourself.
Excellent communication skills, flexible attitude and capable of multi-tasking and working to tight deadlines and under pressure.
The ability to get on with and to influence people both internally and externally and to achieve objectives.
Clear thinker, who can work independently and show leadership in managing and undertaking activities.
Knowledgeable of, and sympathetic to, the commercial and business aspects of any transaction.

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Refine Your Search

director of quality assurance jobs in london, eng

Head of Quality Assurance and Regulatory Affairs

Director, Clinical Quality Assurance

Head of Quality

Head of Assessment & Quality

Head of Quality & Partnerships (1FTE, FTC)

Head of Computerized Systems Quality Assurance & Validation

Head of Safeguarding and Quality Assurance - Adults

Head of Quality Engineering

Head of Quality Engineering

Quality Risk Senior Director/Managing Director (QRM) EMEA Tax

Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

Quality Risk Senior Director/Managing Director (QRM) EMEA Tax

Head of QA and Test Automation

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