Quality and regulatory affairs manager Work, Jobs in Waltham Abbey, Eng (with Salaries)

Quality and Regulatory Manager
Advanced Healthcare Technology Ltd —Waltham Cross
- £50,000 - £60,000 a year
- Full-time
- No degree
- Organisational skills
- In-person
- Free parking
Quick apply
7d
Regulatory Affairs Manager UK&I
Medtronic —Watford
- £71,760 - £107,640 a year
- Full-time
- Analysis skills
- Project management
- Organisational skills
Head of Medical Affairs, UK
Genmab —London
- £123,800 - £185,700 a year
- Full-time
- Doctoral degree
- English
- Leadership
- Annual leave
Regulatory Affairs Associate/Manager
Transpire BIO Inc. —London
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Senior Manager/Associate Director, Government and Regulatory Affairs
Access Partnership —London
- Hybrid work
Quick apply
13d
Clinical Trials Manager
Gilead Sciences —London
- Full-time
- Management
- Doctoral degree
- Master's degree
Senior Standards and Governance Manager, DeepMind
DeepMind —London
- £228,000 - £248,000 a year
- Full-time
- Bachelor's degree
- No degree
- AI
- Annual leave
12d
GB Sr. Manager, Regulatory Affairs - Europe
The Bountiful Company —London
- Bachelor's degree
- Leadership
- Communication skills
Quick apply
Global Process Manager
Novartis —London
- £39,567.00 - £73,482.50 a year
- Full-time
- Hybrid work
- No degree
5d
Exec Director, Regulatory Affairs
Gilead Sciences —Uxbridge
- Full-time
- Hybrid work
- Management
- Doctoral degree
- English
Regulatory Affairs Manager
pladis —Chiswick Park Station
- Full-time
Regulatory Manager - Pharmaceuticals
University College London Hospitals NHS Foundation Trust —London
- £66,274 - £73,496 a year
- Full-time
Regulatory / Compliance Manager
Sigma Consulting Group —London
- £50,000 a month
- Full-time
- Hybrid work
- Contracts
- AI
- Communication skills
Quick apply
Senior Manager Regulatory Affairs Lifecycle Management Medical Devices
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
8d
Manager - LIFE SCIENCES & HEALTHCARE – EU
Sia —London
- Full-time
- Doctoral degree
- Master's degree
- Business development
Quick apply
Group Marketing Manager, Interventional Oncology & Embolization (EMEA)
Boston Scientific —Hemel Hempstead
- Hybrid work
- Engineering
- English
- Master's degree
Demand Operations Manager - London
Waymo —London
- £92,000 - £96,500 a year
- Full-time
- Hybrid work
- Data analysis skills
- SQL
- Bachelor's degree
Scientific Editor
WebMD —London
- Full-time
- Microsoft Office
- Bachelor's degree
- Organisational skills
Quick apply
Senior Manager/Associate Director
Access Partnership —London
- Remote
14d
Executive Director, Worldwide Operations Office - Pharmacovigilance
Regeneron —Uxbridge
- Doctoral degree
- Master's degree
- Bachelor's degree
- Annual leave

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quality and regulatory affairs manager jobs near waltham abbey, eng

Quality and Regulatory Manager

Advanced Healthcare Technology Ltd
Waltham Cross

Quick apply

Job details

Full-time
£50,000 - £60,000 a year
7 days ago

Benefits

Free parking
Casual dress
Company pension
On-site parking

Qualifications

Quality assurance
HACCP
Organisational skills
Root cause analysis
Internal audits

Full job description

Role Purpose

The Quality and Regulatory Manager is responsible for leading the company’s quality management and regulatory compliance activities to ensure that products are developed, manufactured, released and marketed in compliance with applicable requirements. This is a hands-on role with broad responsibility across the quality management system, technical documentation, post-market activities, supplier quality, internal auditing, and regulatory support for global market access. The jobholder will work closely with senior leadership and cross-functional teams to maintain compliance with applicable international medical device regulations and standards, including ISO 13485, MDSAP and relevant market-specific requirements.

Key Responsibilities

· Maintain and continuously improve the company’s Quality Management System in line with ISO 13485, MDSAP and applicable regulatory requirements.

· Manage the relationship between the company and key regulatory bodies including the company’s Notified Body / Auditors

· Ensure products are correctly classified for regulatory clearance in proposed markets.

· Support and maintain technical documentation, declarations of conformity, labelling compliance, and product records in line with product classification.

· Act as the internal lead for quality assurance and regulatory compliance.

· Plan and conduct internal audits and support external audits by certification bodies, regulatory authorities, customers, and other third parties.

· Manage non-conformances, deviations, CAPA, complaints, and change control processes.

· Support clinical evaluation and human factors processes to ensure that these are met throughout the product life cycle.

· Support post-market surveillance, vigilance reporting, field safety corrective actions, and trend analysis where required.

· Ensure document control processes are effective and that quality records are complete, accurate, and audit-ready.

· Work with Senior Management to ensure culture of compliance is embedded in business processes.

· Support supplier qualification, monitoring, and re-evaluation activities, including supplier audits where appropriate.

· Provide regulatory input for product changes, new product introduction, and international market expansion.

· Monitor changes in applicable regulations, standards, and guidance and assess their impact on the business.

· Coordinate management review inputs, quality metrics, and compliance reporting for leadership.

· Deliver training and guidance to staff on quality and regulatory requirements and promote a strong quality and compliance culture.

· Support product registration and market access activities in territories where the company sells its products, using external specialists where required.

Management Responsibilities

· Direct Reports – Currently none

· Consultants and contractors – as appropriate

Qualifications and Experience

· Degree or equivalent experience in a relevant scientific, engineering, quality, or regulatory discipline.

· Lead Auditor qualified or extensive experience with internal auditing, CAPA, complaints handling, supplier quality, and change control.

· Proven experience in quality assurance and regulatory affairs within the medical device sector.

· Strong working knowledge of ISO 13485 and medical device regulatory requirements relevant to Class I and II devices especially in the USA.

· Experience maintaining technical documentation and quality system records in a regulated environment.

· Experience supporting international regulatory compliance and market access activities is essential.

· Supervise quality and document control activities.

Key Skills and Attributes

· Ability to work independently and pragmatically in an environment with limited resources.

· Strong organisational skills, attention to detail, and the ability to prioritise across multiple responsibilities.

· Confident communicator able to work effectively across departments and with external stakeholders.

· Ability to interpret regulations and translate them into workable internal processes.

· Strong problem-solving and root cause analysis skills.

· Ability to influence without unnecessary bureaucracy.

· Comfortable balancing compliance requirements with business needs and operational realities.

· High integrity, accountability, and commitment to patient safety and product quality.

Reporting and Working Relationships

This role reports to the Managing Director.

Key relationships with manufacturing, engineering, supply chain, customer service, and commercial teams.

Pay: £50,000.00-£60,000.00 per year

Benefits:

Casual dress
Company pension
Free parking
On-site parking

Work Location: In person

Quick apply

Refine Your Search

quality and regulatory affairs manager jobs in waltham abbey, eng

Quality and Regulatory Manager

Regulatory Affairs Manager UK&I

Head of Medical Affairs, UK

Regulatory Affairs Associate/Manager

Senior Manager/Associate Director, Government and Regulatory Affairs

Clinical Trials Manager

Senior Standards and Governance Manager, DeepMind

GB Sr. Manager, Regulatory Affairs - Europe

Global Process Manager

Exec Director, Regulatory Affairs

Regulatory Affairs Manager

Regulatory Manager - Pharmaceuticals

Regulatory / Compliance Manager

Senior Manager Regulatory Affairs Lifecycle Management Medical Devices

Manager - LIFE SCIENCES & HEALTHCARE – EU

Group Marketing Manager, Interventional Oncology & Embolization (EMEA)

Demand Operations Manager - London

Scientific Editor

Senior Manager/Associate Director

Executive Director, Worldwide Operations Office - Pharmacovigilance

I want to receive the latest job alerts for quality and regulatory affairs manager in waltham abbey, eng

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