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

Regulatory Affairs Manager
TOGL (Holdings) Limited —Cambridge
- Full-time
- English
- AI
- Business
- Annual leave
Quick apply
7d
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
8d
Regulatory Affairs Specialist
Cambridge Consultants —Cambridge
- Project management
- Leadership
Senior QA Auditor - 60% - 80%
Healx —Cambridge
- Part-time
- Hybrid work
- Analysis skills
- Bachelor's degree
- Travel
- Annual leave
- Work from home
Quick apply
Regulatory Affairs Director
AstraZeneca —Cambridge
- Leadership
- Communication skills
14d
Quality Assurance Specialist
TOGL (Holdings) Limited —Cambridge
- Full-time
- Engineering
- Microsoft Office
- Analysis skills
- Annual leave
Quick apply
7d
Head of Programme Management
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Machine learning
- AI
- Communication skills
- Annual leave
- Life insurance
Quick apply
Project Manager (AI models)
Qureight Ltd —Cambridge
- £56,000 - £61,000 a year
- Full-time
- Hybrid work
- Machine learning
- Communication skills
- Annual leave
- Life insurance
Quick apply
9d
Service Manager, Governance
Cross Keys Homes —Peterborough
- £69,061 - £72,696 a year
- Full-time
- Project management
- Organisational skills
- Business
8d
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
9d
Clinical Site Manager
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Machine learning
- Organisational skills
- Time management
- Annual leave
- Life insurance
Quick apply
Associate Director, Portfolio Project Management
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- PMP
- Project management
- Organisational skills
- Annual leave
- Employee assistance programme
Quick apply
14d
Marketing Communications Manager
Cycle Pharmaceuticals —Cambridge
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Gym membership
- Flexible schedule
10d
Senior Director, Biostatistics
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- Management
- Leadership
- Annual leave
- Employee assistance programme
Quick apply
Quality Assurance Manager
Activinsights Ltd —Kimbolton
- Full-time
- Bachelor's degree
- No degree
- In-person
- Free parking
- Life insurance
Quick apply
3d

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Regulatory Affairs Manager

TOGL (Holdings) Limited
Cambridge

Quick apply

Job details

Full-time
7 days ago

Benefits

Annual leave
Company pension

Qualifications

Biology
English
Diagnostic evaluation
Change management
AI
Business
Communication skills
FDA regulations
Category C Licence

Full job description

TOGL(Holdings)Limited is a diagnostics company focused on diseases of the gastrointestinal tract. Our current research and validation programme targets accurate and efficient triage of patients with symptoms of colorectal cancer (CRC). We are looking for proactive, experienced, focused, and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company. As we progress towards commercialising a test for CRC, we are looking for a Regulatory Manager to lead the development process through relevant regulatory pathways.

Responsibilities:

Lead Regulatory Affairs activities for medical devices, in vitro diagnostic medical devices (IVDs), including software as an IVD (SaMD) and genomic diagnostic technologies.
Develop, maintain and update Technical Documentation in accordance with EU MDR, IVDR and other applicable regulatory requirements.
Support the development and implementation of regulatory strategies for new product development, product changes and lifecycle management.
Prepare and maintain regulatory documentation including Technical Files, Risk Management Files, Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Biological Evaluation Reports (BERs) and associated technical documentation.
Provide regulatory input throughout the product development lifecycle, ensuring compliance with design control, verification, validation and change management processes.
Lead regulatory activities relating to analytical performance, clinical performance, scientific validity and software validation.
Support Post-Market Surveillance (PMS), vigilance, trend reporting and regulatory compliance activities.
Conduct regulatory impact assessments and provide guidance on product, manufacturing and quality system changes.
Work collaboratively with R&D, Software, Bioinformatics, Clinical and Quality teams to ensure regulatory requirements are integrated into product development.
Support regulatory submissions, Notified Body interactions and market access activities within the EU, UK and other international markets.
Provide regulatory training and technical guidance to internal teams and support the Person Responsible for Regulatory Compliance (PRRC) where required.
Monitor changes to relevant regulations, standards and guidance, assessing their impact on the business and products.

Requirements

Degree in Biomedical Science, Molecular Biology, Genetics, Life Sciences or a related scientific discipline.
Significant Regulatory Affairs experience within the medical device and/or in vitro diagnostic (IVD) industry.
Strong working knowledge of the EU In Vitro Diagnostic Regulation (IVDR (EU) 2017/746) and Medical Device Regulation (EU MDR 2017/745).
Demonstrable experience developing and maintaining Technical Documentation for medical devices and/or IVDs.
Experience supporting the regulatory development of novel IVD technologies, including genomic, molecular and software-based diagnostics.
Experience with Software as an IVD (SaMD) and an understanding of software lifecycle and validation requirements (e.g. IEC 62304).
Strong understanding of design control, product lifecycle management and regulatory change management.
Hands-on experience with Risk Management in accordance with ISO 14971.
Experience preparing or contributing to Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Biological Evaluation Reports (BERs) and Post-Market Surveillance (PMS) documentation.
Experience supporting regulatory submissions and interactions with Notified Bodies and Competent Authorities.
Working knowledge of ISO 13485 and associated regulatory standards.
Excellent written and verbal communication skills, with the ability to communicate effectively across multidisciplinary teams.
Highly organised, pragmatic and able to manage multiple regulatory projects within a fast-paced development environment.
Excellent written and verbal communication skills in English.

Desirable

Experience with Class C IVDs under IVDR.
Experience supporting AI-enabled or bioinformatics-driven diagnostic technologies.
Experience with analytical performance, clinical performance and scientific validity studies.
Experience with UKCA, FDA or other international regulatory frameworks.
Previous experience acting as, or supporting, the Person Responsible for Regulatory Compliance (PRRC).

Benefits

25 days annual leave (plus bank holidays).
Pension contribution.
Competitive Salary.
Employee wellbeing initiatives.

Quick apply

Refine Your Search

regulatory affairs lead jobs in swavesey, cam

Regulatory Affairs Manager

Head of Quality Assurance and Regulatory Affairs

Regulatory Affairs Specialist

Senior QA Auditor - 60% - 80%

Regulatory Affairs Director

Quality Assurance Specialist

Head of Programme Management

Project Manager (AI models)

Service Manager, Governance

Data Partnerships Project Manager

Clinical Site Manager

Associate Director, Portfolio Project Management

Marketing Communications Manager

Senior Director, Biostatistics

Quality Assurance Manager

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