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
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