Medical Devices Regulatory Affairs Specialist | Cambridge

Newton Colmore; Cambridge; Sur place; GBP 52 000 - 75 000; Plein temps

Résumé du poste

Newton Colmore is seeking a Regulatory Affairs Specialist for Medical Devices in Cambridge. You will support a wide range of projects, work with engineers, scientists and designers, and help ensure compliance with global regulatory expectations across medical and non-medical sectors.

You will apply knowledge of ISO 9001, ISO 13485 and FDA 21 CFR 820, monitor regulatory changes, contribute to regulatory planning, and support audits and lifecycle management from development through commercial

Qualifications

• Degree in regulatory affairs or a related field for medical devices.
• Experience developing or contributing to regulatory strategies.
• Familiarity with ISO 9001, ISO 13485 and FDA 21 CFR 820.

Responsabilités

• Provide regulatory support across the business and multidisciplinary teams.
• Interpret regulatory requirements and advise on compliant pathways.
• Monitor changes in international regulations and communicate updates.
• Support internal and external audits and lifecycle management.

Connaissances

Regulatory affairs

Regulatory strategy

ISO 13485 knowledge

FDA 21 CFR 820 knowledge

Regulatory communications

Cross-functional collaboration

Formation

Bachelor's degree in a relevant field

Description du poste

Newton Colmore is seeking a Regulatory Affairs Specialist for Medical Devices in Cambridge. You will support a wide range of projects, work with engineers, scientists and designers, and help ensure compliance with global regulatory expectations across medical and non-medical sectors.

You will apply knowledge of ISO 9001, ISO 13485 and FDA 21 CFR 820, monitor regulatory changes, contribute to regulatory planning, and support audits and lifecycle management from development through commercial