Director of regulatory affairs Work, Jobs in Cuffley, Hrt (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
Head of/Director, International Regulatory Affairs
Hims & Hers —London
- £140,000 - £155,000 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- AI
- Annual leave
Senior Medical Director, Global Medical Affairs – Neurosciences (Migraine Lead)
Ipsen Biopharm Ltd —London
- Full-time
- Doctoral degree
- English
- Leadership
Head of/Director, Government Affairs - UK & EU
Hims & Hers —London
- £140,000 - £155,000 a year
- Full-time
- Hybrid work
- Spanish
- AI
- Communication skills
- Annual leave
(Senior) Director Global Medical Affairs
BioNTech AG —London
- £168,100 - £318,300 a year
- Full-time
- Doctoral degree
- Travel
- Leadership
Director - Regulatory Affairs Lifecycle Management Non-Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
Director, Regulatory Affairs, EU Services
Bio Pharma Resourcing —London
- £60,000 a year
- Management
- Public speaking
- Windows
Associate Director, Regulatory Innovation
IQVIA —London
- Full-time
- Remote
- Bachelor's degree
- No degree
- AI
- Work from home
CMC Associate Director
Androlabs —London
- £85,000 - £108,000 a year
- Full-time
- Hybrid work
- Management
- Project management
- IT
- Annual leave
Quick apply
Director, Regulatory Affairs, Europe
GE HEALTHCARE —Chalfont Saint Giles
- Engineering
- Master's degree
- Bachelor's degree
Director - Regulatory Affairs Lifecycle Management Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
Director Safety Surveillance & Risk Management (12 months fix term contract)
Viatris —Hatfield
- Full-time
- Hybrid work
- Bachelor's degree
- Time management
- Health & wellbeing programme
- Employee assistance programme
Director, Medical Affairs - Remote
Emergent BioSolutions —London
- £93,000 - £112,500 a year
- Remote
- Doctoral degree
- Project management
- Organisational skills
Senior Manager/Associate Director, Government and Regulatory Affairs
Access Partnership —London
- Hybrid work
Quick apply
Associate Director (Public Affairs - Tech Policy & Regulation)
Hanbury Strategy —London
- Hybrid work
- Presentation skills
- Communication skills
- Health & wellbeing programme
- Annual leave
Director, Government Affairs and Advocacy - Europe and International
GlaxoSmithKline —London
- Full-time
- Management
- Bachelor's degree
- Travel
12d
Associate Director, Regulatory Diagnostics
Novartis —London
- £67,900 - £126,100 a year
- Full-time
- Hybrid work
- Communication skills
- Negotiation
Director, European and UK Public Policy
Whatnot —London
- £200,000 - £276,000 a year
- Full-time
- Hybrid work
- Driving
- In-person
- Communication skills
- Work from home
Director, Product and Clinical Training (Hybrid)
Insulet Corporation —London
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Associate Director - Regulatory Affairs Operations
Perrigo —London
- Hybrid work
- In-person
- Leadership

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director of regulatory affairs jobs near cuffley, hrt

Quality and Regulatory Manager

Advanced Healthcare Technology Ltd
Waltham Cross

Quick apply

Job details

Full-time
£50,000 - £60,000 a year

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

director of regulatory affairs jobs in cuffley, hrt

Quality and Regulatory Manager

Head of/Director, International Regulatory Affairs

Senior Medical Director, Global Medical Affairs – Neurosciences (Migraine Lead)

Head of/Director, Government Affairs - UK & EU

(Senior) Director Global Medical Affairs

Director - Regulatory Affairs Lifecycle Management Non-Medicines

Director, Regulatory Affairs, EU Services

Associate Director, Regulatory Innovation

CMC Associate Director

Director, Regulatory Affairs, Europe

Director - Regulatory Affairs Lifecycle Management Medicines

Director Safety Surveillance & Risk Management (12 months fix term contract)

Director, Medical Affairs - Remote

Senior Manager/Associate Director, Government and Regulatory Affairs

Associate Director (Public Affairs - Tech Policy & Regulation)

Director, Government Affairs and Advocacy - Europe and International

Associate Director, Regulatory Diagnostics

Director, European and UK Public Policy

Director, Product and Clinical Training (Hybrid)

Associate Director - Regulatory Affairs Operations

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