Human Factors Regulatory Consultant
1 week ago
Human Factors Regulatory Consultant
Cambridge
£40k-£55k (dep on exp)
An excellent career opportunity has opened for an experienced technically skilled Human Factors Regulatory Consultant to join a highly regarded Technology Development Consultancy in Cambridgeshire. The Human Factors Regulatory Consultant will play a pivotal role within the medical sector - joining their world-class team of product developers and R&D strategists.
You will have the opportunity to support and develop HF/Useability Engineering files and be consulting directly with clients on key Human Factors projects. This position has a large amount of collaboration with multidisciplinary medical device development teams in the Innovation department, not to mention collaborating with clients’ project teams also.
The Human Factors Regulatory Consultant will suit someone who has a background in mechanical engineering who has moved into Human Factors related areas, within a medical device development area - thus having knowledge and experience of regulatory compliance would be a distinct advantage.
Ideally, the Human Factors Regulatory Consultant, will have the following:
- Proven experience working in a HF function guiding pragmatic activities and documenting outputs in accordance with FDA human factors guidelines, MDR, IEC: 62366 and HE 75 regulatory requirements. These include:
- Creation of use specifications, user interface specifications and user interface evaluation plans, workflow assessment and task analysis.
- Hazard and risk related documentation and traceability including uFMEA/UERAs
- Experience of medical device project quality management in a project-based organisation
- Knowledge of ISO 13485, FDA QSR and Medical Device Directive (MDD)/Medical Device Regulations (MDR) to support additional quality engineering functions.
- A degree level qualification in a relevant engineering, design or science discipline.
-
Human Factors Engineering Consultant
3 days ago
Cambridgeshire, United Kingdom The One Group Full timeOne of the things that make this company so special is how they look after Their People. Everyone says what a supportive, fun and diverse place it is to work! Medical Devices and Life Sciences products require a massive input from **Human Factors** and that is what this role is all about. Supporting design through product development stages, adhering to...
-
Regulatory Toxicologist
4 days ago
Cambridgeshire, United Kingdom VRS Recruitment Full timeExciting opportunity for a regulatory toxicologist to join a successful and well-established regulatory consultancy servicing the biocide and PPP sectors in the UK and EU. They are growing in size and range of services provided and need a Regulatory Toxicologistto work on risk assessments and the toxicology section of registration documents for either or...
-
Graduate Engineer
2 months ago
Cambridge, Cambridgeshire, United Kingdom CK Group Full time €22CK Group are recruiting for a Quality Engineer, to join a company in the Pharmaceutical industry, at their site based in Cambridge, on a contract basis for 12 months. Hourly - Up to £21.62 PAYE or £24.Quality Engineer Role: Lead design control and risk management activities for combination product development programs. Support and facilitation...
-
Graduate Engineer
1 month ago
Cambridge, Cambridgeshire, United Kingdom CK Group Full time €22 - €24CK Group are recruiting for a Quality Engineer, to join a company in the Pharmaceutical industry, at their site based in Cambridge, on a contract basis for 12 months. Hourly - Up to £21.62 PAYE or £24.Quality Engineer Role: Lead design control and risk management activities for combination product development programs. Support and...
-
Quality Engineer
1 month ago
Cambridge, Cambridgeshire, United Kingdom CK Group Full time €22 - €24CK Group are recruiting for a Quality Engineer, to join a company in the Pharmaceutical industry, at their site based in Cambridge, on a contract basis for 12 months. Salary: Hourly - Up to £21.62 PAYE or £24.23 Umbrella. Quality Engineer Role: Lead design control and risk management activities for combination product development programs. Support...
-
Quality Engineer
2 months ago
Cambridge, Cambridgeshire, United Kingdom CK Group Full time €22CK Group are recruiting for a Quality Engineer, to join a company in the Pharmaceutical industry, at their site based in Cambridge, on a contract basis for 12 months. Salary: Hourly - Up to £21.62 PAYE or £24.23 Umbrella. Quality Engineer Role: Lead design control and risk management activities for combination product development programs. ...
-
Senior Regulatory Professional
3 weeks ago
Cambridgeshire and Peterborough, United Kingdom Boydconsultants Full timeJob Description:We are looking for a highly experienced Senior Regulatory Professional to join our award-winning regulatory team at Boydconsultants.The ideal candidate will have a strong background in regulatory affairs, with excellent knowledge of regulatory guidelines and practices.Key Responsibilities:Work with and deputize for the Vice President,...
-
Director of Regulatory Policy Projects
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time €130,000Job Title: Senior Director, Regulatory Affairs Job Type: Full-time, permanent position Cambridge, UK – Hybrid Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities. The business has a specific...
-
Medical Device Specialist
3 weeks ago
Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full timeClinical Development ScientistJob OverviewOur client based in Cambridge is seeking an experienced Device Development Scientist with Drug Delivery expertise to join their multidisciplinary team. The successful candidate will work closely with design, mechanical, quality, compliance regulatory, human factors, and formulation engineers and scientists to develop...
-
Regulatory Affairs Manager
3 weeks ago
Cambridgeshire and Peterborough, United Kingdom ELP Consult Full timeJob Title: Regulatory Affairs ManagerJob DescriptionAs a Regulatory Affairs Manager at ELP Consult, you will be responsible for ensuring that our operations comply with regulatory requirements and internal policies. This role involves developing and implementing compliance policies and procedures, reviewing internal processes, and providing compliance...
-
Biopesticide Lead
4 days ago
Cambridgeshire, United Kingdom VRS Recruitment Full timeThis is an opportunity to become the biopesticide lead and head up a new team focussing on biopesticide registrations and risk assessments. The role will involve providing expertise and advice on study data requirements, developing registration strategy,data gathering, study report writing and summarising, dossier writing, project management and liaison with...
-
Senior Director Regulatory Affairs
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time €130,000Job Title: Senior Director, Regulatory Affairs Job Type: Full-time, permanent position Location: Cambridge, UK – Hybrid Remuneration: £130,000 + Benefits Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug...
-
Senior Director Regulatory Affairs
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time €130,000Job Title: Senior Director, Regulatory Affairs Job Type: Full-time, permanent position Location: Cambridge, UK – Hybrid Remuneration: £130,000 + Benefits Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug...
-
Regulatory Affairs Leadership Opportunity
20 hours ago
Cambridgeshire and Peterborough, United Kingdom Cpl Healthcare Full timeJob Title:Senior Director, Regulatory AffairsRemuneration: £130,000 + Benefits per annum in Cambridge, UK (hybrid role)Cpl Healthcare collaborates with a renowned global drug development consultancy business supporting pharma, biotechs, spin-outs, and academic groups.Key Responsibilities:Lead client projects providing strategic regulatory advice on gap...
-
Validation Consultant
7 months ago
Cambridgeshire, United Kingdom PM Group Full time**Validation Consultant**: - Contract - Onsite - Cambridgeshire, United Kingdom - CQV - 7343 **Overview - PM Group is looking for an Equipment Validation Consultant to support an API site in East Anglia to join them at the end of September. **Responsibilities **Responsibilities**: - Equipment biased - Dissolution of vessels, list reactor, spray drier and...
-
Regulatory Affairs Senior Director
7 days ago
Cambridgeshire and Peterborough, United Kingdom Cpl Healthcare Full timeCpl Healthcare is collaborating with a prestigious global drug development consultancy business.The company specializes in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities.This includes advanced therapies, cell therapy, ATMPS, and other niche therapeutic areas.Salary: £130,000 + Benefits (estimated)Location:...
-
Peterborough, Cambridgeshire, United Kingdom I C Talent Ltd Full timeHUMANITIES TEACHER! I C TALENTare supporting secondary school in Peterborough who are recruiting for a Humanities Teacher to focus on Religious Education, History and Geography on a full time basis for long term cover. This is a fantastic opportunity to work with an established team and make a positive impact to pupils in KS3 or KS4. The successful...
-
Consultant Vacancy in Wales
3 weeks ago
Cambridgeshire and Peterborough, United Kingdom National Locums Full timeNational Locums is recruiting a highly experienced Vascular Surgeon to fill a consultant vacancy at our client's site in Wales.This is an excellent opportunity for a talented professional to take up a challenging role and demonstrate their expertise in vascular surgery.We anticipate that the chosen candidate will possess strong clinical skills and a proven...
-
Senior Quality Assurance Engineer
7 days ago
Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full timeJob DescriptionWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team in Cambridge. As a key member of our quality assurance department, you will be responsible for ensuring the delivery of high-quality medical devices and combination products.Key Responsibilities:Lead design control and risk management activities for combination...
-
Compliance Manager
2 weeks ago
Cambridgeshire and Peterborough, United Kingdom ELP Consult Full timeAt ELP Consult, we are seeking an experienced Compliance Manager to join our team. The ideal candidate will have a strong background in regulatory compliance and a proven track record of ensuring operational excellence.About the RoleThis is a key leadership position responsible for overseeing and implementing our company's compliance policies and procedures....