Regulatory affairs lead Work, Jobs in Bluntisham, Cam (with Salaries)

Quality Assurance & Regulatory Affairs (QARA) Manager
Cambrionix —Cambridge
- £55,000 - £60,000 a year
- Hybrid work
- Travel
- Contracts
Quick apply
2d
Head of Quality Assurance and Regulatory Affairs
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Project management
- Bachelor's degree
- Machine learning
- Annual leave
- Life insurance
Quick apply
19h
Senior Regulatory Affairs Director
AstraZeneca —Cambridge
- Presentation skills
- Organisational skills
- Leadership
13d
Regulatory Affairs Specialist
Cambridge Consultants —Cambridge
- Project management
- Leadership
Service Manager, Governance
Cross Keys Homes —Peterborough
- £69,061 - £72,696 a year
- Full-time
- Project management
- Organisational skills
- Business
5h
Global Medical Advisor - Anti-Infectives
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- ICU experience
- Communication skills
Associate Director, Portfolio Project Management
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- PMP
- Project management
- Organisational skills
- Annual leave
- Employee assistance programme
Quick apply
6d
Senior QA Auditor - 60% - 80%
Healx —Cambridge
- Part-time
- Hybrid work
- Analysis skills
- Bachelor's degree
- Travel
- Annual leave
- Work from home
Quick apply
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Leadership
Regulatory Affairs Director
AstraZeneca —Cambridge
- Leadership
- Communication skills
6d
Regulatory Affairs Systems and Data Manager
Mundipharma —Cambridge
- Full-time
- Hybrid work
- Communication skills
Global Medical Advisor - Rescue Treatments
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Communication skills
Medical Director, Medical Safety
Jazz Pharmaceuticals —Cambridge
- £113,600 - £170,400 a year
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
Head of Programme Management
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Machine learning
- AI
- Communication skills
- Annual leave
- Life insurance
Quick apply
Director of Statistical Science – Global Medical Affairs/Payer Biometrics
AstraZeneca —Cambridge
- Doctoral degree
- Master's degree
- Presentation skills
1d
Data Partnerships Project Manager
Qureight Ltd —Cambridge
- £56,000 - £61,000 a year
- Full-time
- Hybrid work
- Machine learning
- Negotiation
- Annual leave
- Life insurance
Quick apply
1d
Clinical Site Manager
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Machine learning
- Organisational skills
- Time management
- Annual leave
- Life insurance
Quick apply
Residential Care Home Manager
Shaw Healthcare —Oundle
- £47,500 a year
- Full-time
- Leadership
- Annual leave
- Referral programme
Quick apply
3d
Senior Medical Writer - FSP
IQVIA —Cambridge
- Microsoft Word
- Doctoral degree
- Master's degree
Medical Director, UK and Ireland
Mundipharma —Cambridge
- Full-time
- English
- Leadership

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regulatory affairs lead jobs near bluntisham, cam

Quality Assurance & Regulatory Affairs (QARA) Manager

Cambrionix
Cambridge

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Job details

Freelance
£55,000 - £60,000 a year
2 days ago

Qualifications

Contracts

Full job description

Role Overview
We are seeking an experienced QARA Manager for a 6-month contract to lead global regulatory compliance and quality assurance for our hardware product portfolio. Operating on a hybrid basis from our Cambridge office, you will collaborate closely with our internal engineering team and coordinate directly with our contract manufacturers. You will own the re-certification processes for CE, BIS, and UL, manage EMS and RoHS compliance, and ensure all existing products and New Product Introductions (NPI) meet stringent international standards.

Key Responsibilities
Regulatory Re-Certification & Compliance

Lead and execute re-certification projects for existing hardware products, specifically focusing on CE, BIS, and UL marks.
Maintain, update, and manage Technical Files, Declarations of Conformity, and regulatory documentation.
Act as the primary point of contact for external test houses, notified bodies, and regulatory agencies.

Environmental & Materials Compliance

Oversee and ensure full compliance with RoHS, REACH, and WEEE directives across all product lines.
Manage Environmental Management System (EMS) requirements and alignment with relevant standards.

Lifecycle & Cross-Functional Collaboration

Collaborate with the internal engineering team to retrieve technical drawings, schematics, and component data.
Proactively monitor, analyze, and manage upcoming global regulatory changes impacting current products.
Implement necessary engineering change orders (ECOs) to maintain continuous market compliance.

Supply Chain & NPI

Travel to contract manufacturers to audit production compliance, resolve quality issues, and align on testing processes.
Serve as the QARA lead on NPI teams to embed compliance requirements into early product design.
Define compliance roadmaps, testing strategies, and certification schedules for new hardware launches.

Qualifications and Experience

Experience: 5+ years in QARA roles within hardware, electronics, or manufacturing.
Certifications: Proven track record securing and maintaining CE, BIS, and UL certifications.
Standards Knowledge: Deep technical expertise in RoHS, REACH, and EMS frameworks.
Collaboration: Experience partnering with internal engineering teams and managing contract manufacturers.
Mobility: Willingness and ability to travel to contract manufacturing sites as required.
Efficiency: Ability to operate autonomously and deliver results within a 6-month window

Pay: £55,000.00-£60,000.00 per year

Experience:

QARA roles within hardware, electronics, or manufacturing.: 5 years (required)
Deep technical expertise in RoHS, REACH, and EMS frameworks.: 3 years (preferred)

Work authorisation:

United Kingdom (required)

Work Location: Hybrid remote in Cambridge (Cambridgeshire, East of England Region)

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Refine Your Search

regulatory affairs lead jobs in bluntisham, cam

Quality Assurance & Regulatory Affairs (QARA) Manager

Head of Quality Assurance and Regulatory Affairs

Senior Regulatory Affairs Director

Regulatory Affairs Specialist

Service Manager, Governance

Global Medical Advisor - Anti-Infectives

Associate Director, Portfolio Project Management

Senior QA Auditor - 60% - 80%

(Senior) Global Medical Director, Established Brands

Regulatory Affairs Director

Regulatory Affairs Systems and Data Manager

Global Medical Advisor - Rescue Treatments

Medical Director, Medical Safety

Head of Programme Management

Director of Statistical Science – Global Medical Affairs/Payer Biometrics

Data Partnerships Project Manager

Clinical Site Manager

Residential Care Home Manager

Senior Medical Writer - FSP

Medical Director, UK and Ireland

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