Hybrid Regulatory Affairs Innovator — IVD/MD

SPD Development Company Ltd; Bedford; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid working

Annual discretionary bonus

25 days annual leave + bank holidays

Pension scheme

Private Medical Insurance

Parental pay

Health & Wellbeing programme

Life assurance

Electric car charging points

Job summary

SPD Swiss Precision Diagnostics GmbH seeks a Regulatory Affairs Specialist - Innovation to join the Regulatory Affairs team at the Bedford Innovation Centre, with hybrid working options. The role focuses on regulatory strategies for new product development in the IVD/Medical Device space and involves collaboration with cross-functional teams and external bodies.

Ideal candidates hold a BSc in life sciences and have hands-on regulatory experience, knowledge of ISO 13485, IVDR/MDR, and FDA

Qualifications

• Hands-on regulatory experience in IVD or medical devices.
• Strong written and verbal communication in English.
• Ability to work with Notified Bodies and regulatory authorities.

Responsibilities

• Develop and execute regulatory strategies for new product development.
• Support market access and regulatory submissions for IVD/MD products.
• Provide regulatory guidance to cross-functional teams throughout the project lifecycle.

Skills

Regulatory knowledge

Communication skills

Cross-functional collaboration

Education

BSc degree

Job description

SPD Swiss Precision Diagnostics GmbH seeks a Regulatory Affairs Specialist - Innovation to join the Regulatory Affairs team at the Bedford Innovation Centre, with hybrid working options. The role focuses on regulatory strategies for new product development in the IVD/Medical Device space and involves collaboration with cross-functional teams and external bodies.

Ideal candidates hold a BSc in life sciences and have hands-on regulatory experience, knowledge of ISO 13485, IVDR/MDR, and FDA