Quality and Regulatory Affairs Specialist
5 months ago
Biochrom is part of Harvard Bioscience (HBIO), a global business providing life science, laboratory apparatus worldwide.
Reporting to Biochrom QRA Manager, the **Quality and Regulatory Affairs Specialist** (QRA Specialist) supports our _in-vitro_ diagnostic product registrations, timely undertaking of post market surveillance as well as monitoring regulatory developments. You will also contribute to maintaining our regulatory compliance certifications and driving continuous improvement activities.
**Requirement of Quality and Regulatory Affairs Specialists**
- Bachelor’s degree within a life science.
- Experience in an IVD environment. 1-2 years in IVDR regulatory compliance
- Knowledge of ISO 13485:2016, ISO 14971:2019, QSR/ QMSR, IVDD and IVDR.
- Experience of process / procedure / QMS development and implementation
- Passionate about Regulatory Compliance.
- Good interpersonal skills, with the ability to work across teams.
- Comfortable working in a small team.
- Excellent communication skills required, written and verbal. Write procedures, perform presentations to staff and management.
**Responsibilities of Quality and Regulatory Affairs Specialists**
- Provide supporting quality and regulatory expertise to the organisation.
- Maintains awareness of new and changing regulatory requirements. Inform teams of such changes and update QARA procedures accordingly.
- Support internal training activities. Provide interpretation of regulatory compliance requirements.
- Support the review of technical documentation for submissions as well as responses to Notified Body and relevant Competent Authorities, where applicable.
- Support the review and approval of product labelling and promotional material.
- Support regulatory compliance activities for both product and quality system.
- Assist with internal and external third-party audits.
- Analyse product and quality system data. Prepare relevant reports.
- Actively participate in process, product, and system efforts to advance a continuous improvement culture.
- Any other responsibilities that may be required by the business.
**Desirable Skills**:
- Experience in molecular instrument-based IVD platforms.
- R&D background preferred.
**Job Types**: Permanent, Full-time, Part-time, Temporary
**Salary**: £40,000.00-£45,000.00 per year
Expected hours: 37.5 per week
**Benefits**:
- Casual dress
- Company events
- Company pension
- Cycle to work scheme
- Free parking
- Health & wellbeing programme
- On-site parking
- Private dental insurance
- Private medical insurance
- Sick pay
Schedule:
- Monday to Friday
**Education**:
- PhD (preferred)
**Experience**:
- molecular instrument-based IVD platforms: 2 years (required)
Work Location: Hybrid remote in Cambridge CB25 9PE
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance SpecialistNewton Colmore Consulting Ltd is seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join their team in Cambridge. The successful candidate will work closely with the Quality Assurance and Regulatory Affairs Manager to provide quality assurance and regulatory affairs advice on the...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance SpecialistWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices recruitment team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation of new products...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeJob Title: Regulatory Affairs and Quality Assurance SpecialistJob Description:We are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our medical devices team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeJob Title: Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation of new products and the...
-
Regulatory Affairs Specialist
1 week ago
Cambridge, Cambridgeshire, United Kingdom Reed Engineering Full timeJob Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to lead our quality and regulatory projects and functions.Key Responsibilities:* Implement, maintain, and improve a comprehensive Quality Management System in accordance with relevant quality standards* Stay updated on global regulatory...
-
Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Philips Full timeJob Title: Regulatory Affairs SpecialistAt Philips, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for medical devices.Key Responsibilities:Develop and implement regulatory strategies to ensure...
-
Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Philips Full timeJob Title: Regulatory Affairs SpecialistAt Philips, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for medical devices.Key Responsibilities:Develop and implement regulatory strategies to ensure...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices recruitment team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices recruitment team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...
-
Cambridge, Cambridgeshire, United Kingdom Hologic, Inc. Full timeAt Hologic, Inc., we are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team. As a leading innovator of women's health, we empower people to live healthier lives everywhere, every day.Our quality and regulatory affairs team is responsible for staying up-to-date on new, changing, and existing regulatory requirements....
-
Regulatory Affairs Specialist EU
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full timeSenior Regulatory Affairs Associate EU Job DescriptionOur client, a well-established biopharmaceutical company, is seeking an experienced Senior Regulatory Affairs Associate EU to join their team on a 12-month contract basis, with potential for extension.Key Responsibilities:Support a Regulatory Affairs Lead with assigned projects and products to execute the...
-
Regulatory Affairs Specialist EU
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full timeSenior Regulatory Affairs Associate EU Job DescriptionOur client, a well-established biopharmaceutical company, is seeking an experienced Senior Regulatory Affairs Associate EU to join their team on a 12-month contract basis, with potential for extension.Key Responsibilities:Support a Regulatory Affairs Lead with assigned projects and products to execute the...
-
Regulatory Affairs and Quality Assurance Specialist
2 months ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...
-
Regulatory Affairs and Quality Assurance Specialist
2 months ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...
-
Regulatory Affairs and Quality Assurance Specialist
2 months ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key ResponsibilitiesProvide quality assurance and regulatory...
-
Regulatory Affairs and Quality Assurance Specialist
2 months ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key ResponsibilitiesProvide quality assurance and regulatory...
-
Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key Responsibilities:Assist...
-
Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key Responsibilities:Assist...
-
Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...
-
Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...