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

Regulatory Affairs Specialist
Cambridge Consultants —Cambridge
- Continuous improvement
- Leadership
Regulatory Affairs Manager
TOGL (Holdings) Limited —Cambridge
- Full-time
- English
- Business
- Communication skills
- Annual leave
Quick apply
Analytical Development Lead
Cycle Pharmaceuticals —Cambridge
- Full-time
- Hybrid work
- Analysis skills
- Continuous improvement
- Analytics
- Gym membership
14d
Pharmacovigilance Associate
Cycle Pharmaceuticals —Cambridge
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Analysis skills
- Gym membership
- Flexible schedule
7d
Global Patient Safety Business Excellence, Senior Manager
Amgen —Cambridge
- PMP
- Continuous improvement
- Agile
6h
Director Research & Development (R&D)
Cycle Pharmaceuticals —Cambridge
- Full-time
- Hybrid work
- Doctoral degree
- Business
- Gym membership
7d
Senior QA Auditor - 60% - 80%
Healx —Cambridge
- Part-time
- Hybrid work
- Analysis skills
- Bachelor's degree
- Travel
- Annual leave
- Work from home
Quick apply
Quality Manager
Bragg Life Sciences —Cambridge
- £50,000 - £60,000 a year
- Full-time
- Continuous improvement
- Team management
- In-person
- Employee discount
- Sick pay
Quick apply
3d
Marketing Communications Manager
Cycle Pharmaceuticals —Cambridge
- Full-time
- Hybrid work
- Microsoft Word
- No degree
- Leadership
- Gym membership
- Flexible schedule
Brand Manager
Cycle Pharmaceuticals —Cambridge
- Full-time
- Marketing
- Analysis skills
- Project management
- Gym membership
7d
Product Compliance Engineer
AMOT —Bury St. Edmunds
- Hybrid work
- Schematics
- Engineering
- English
Quick apply
Clinical Development Senior Medical Director - Vascular
GlaxoSmithKline —Stevenage
- £284,625 - £474,375 a year
- Full-time
- Hybrid work
- Doctoral degree
- Conflict management
- In-person
- Annual leave
10d
Senior Director, Biostatistics
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- Mentoring
- Leadership
- Annual leave
- Employee assistance programme
Quick apply
Business Development Lead
DLRC —Letchworth
- CRM software
- Sales
- Data analysis skills
Site Security Controller
Awerian —Cambridge
- Full-time
- Bachelor's degree
- Training & development
- Leadership
- Life insurance
Quick apply
4d
Business Development Proposals Manager
DLRC —Letchworth
- Salesforce
- Continuous improvement
- Organisational skills

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Regulatory Affairs Manager
TOGL (Holdings) Limited —Cambridge
Support the development and implementation of regulatory strategies for new product development, product changes and lifecycle management.
Quick apply
Regulatory Affairs Specialist
Cambridge Consultants —Cambridge
Your role will focus on providing company-wide regulatory support to our project teams, spanning both medical and non-medical disciplines, as well as supporting…

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regulatory affairs lead jobs near cambridge, cam

Regulatory Affairs Specialist

Cambridge Consultants -
Cambridge

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Job details

Qualifications

Stakeholder liaison
Quality assurance
Continuous improvement
Multidisciplinary collaboration
Project leadership
Quality management system (QMS) implementation
Leadership
ISO 13485

Full job description

Overview

We're looking for a Regulatory Affairs Specialist to join us, working across multidisciplinary teams to support and enable breakthrough innovation.

Cambridge Consultants is a global technology and product development consultancy that helps ambitious organisations turn complex ideas into commercially successful products and services.

We combine strategy, science, engineering and design to solve tough technical challenges, across a variety of industries, and this role is key to ensuring this can happen.

What we do

Breakthrough innovation challenges traditional approaches. At Cambridge Consultants our approach to quality applies technical expertise to provide a platform which encourages and facilitates creativity and innovation to meet global regulatory requirements.

The QA Group is responsible for maintaining the quality management system that supports our business processes, complies with regulatory requirements, and satisfies our clients' expectations.

What you will be doing

We are looking for a Regulatory Affairs Specialist to join our team.

Your role will focus on providing company-wide regulatory support to our project teams, spanning both medical and non-medical disciplines, as well as supporting the QA Director and Regulatory Affairs Manager with operational activities of the Quality Management System and related management systems. This is a great opportunity for you to gain experience in a variety of different market areas and expand and deepen your knowledge across multiple industries.

Responsibilities

Your responsibilities will be varied and there is plenty of opportunity for your role to evolve over time. We have listed below the types of things you can expect to be doing:

Use your experience in compliance to product regulations and quality standards (ISO 9001:2015, ISO 13485:2016, FDA QMSR 21 CFR 820), to provide a strategic advantage to client projects while expanding our knowledge and experience of European, US and Asian regulations (for both medical and non-medical applications).

Take initiative in identifying and monitoring key changes in relevant international regulations, guidance and standards, and interpret and communicate what they mean for both the QA team and the wider business.

Lead communications on quality and regulatory updates and run internal improvement initiatives, owning meaningful contributions to CC's global systems as a quality and regulatory technical lead.

Working alongside colleagues in QA and the wider business, support the fulfilment of external audit requirements.
Strongly demonstrate and develop your leadership and project management skills to facilitate the work done by client project teams.
Apply excellent attention to detail, quality assurance expertise and a collaborative approach to process improvements and the maintenance of QMS documentation.

Find pragmatic but robust solutions in problem-solving under tough commercial, technical, time and regulatory constraints. You must understand and demonstrate the need to balance freedom to innovate on the one hand, with rigour in the design process on the other by applying your knowledge and experience of quality management appropriately to the individual project situation.

Be resourceful in your approach to contribute to projects with a widely varying breadth of disciplines, scale, complexity and requirements.

What you can bring

To be successful in this role, we are looking for someone who:

Is a clear thinker, who can work independently, flexibly and inventively to facilitate others and show leadership in managing and undertaking activities
Is a proactive communicator and has the ability to develop relationships across a range of stakeholders, takes ownership of initiatives, delivers results, and strives for continual improvement.
Can demonstrate a track record of developing and executing regulatory strategies that align with business needs and deliverables
Has the skill and experience to interpret regulatory and standard requirements to clarify the downstream implications for our processes
Knowledge of medical device compliance requirements

By submitting an application to Cambridge Consultants, you confirm that the information provided in this application, together with any supporting documentation, is true, complete, and accurate to the best of your knowledge and belief. You understand that any false statement, misleading information, or material omission may render you liable to disqualification from the recruitment process, withdrawal of any offer of employment, or dismissal without notice if discovered following appointment. You acknowledge that the organisation reserves the right to verify the information supplied.

Apply Now

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regulatory affairs lead jobs in cambridge, cam

Regulatory Affairs Specialist

Regulatory Affairs Manager

Analytical Development Lead

Pharmacovigilance Associate

Global Patient Safety Business Excellence, Senior Manager

Director Research & Development (R&D)

Senior QA Auditor - 60% - 80%

Quality Manager

Marketing Communications Manager

Brand Manager

Product Compliance Engineer

Clinical Development Senior Medical Director - Vascular

Senior Director, Biostatistics

Business Development Lead

Site Security Controller

Business Development Proposals Manager

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