Design Control Leader – Medical Devices (ISO 13485)

Gonzales Communications Inc.; Portsmouth; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading biotechnology company is seeking a Design Control Specialist in Portsmouth, UK. The role involves ensuring compliance with quality management standards for medical device development. Candidates should have a degree in a related field and significant experience in regulatory compliance for medical devices. Excellent communication skills and knowledge of ISO regulations are necessary. This is an on-site position offering a chance to make an impact in life sciences.

Benefits

Comprehensive benefit programs

Paid time off

Health care program

Qualifications

• Degree in Science or Engineering related subject or equivalent experience.
• Significant experience within Medical Device Product Development/Quality/Regulatory.
• In-depth knowledge of regulations like ISO 13485 and FDA 21 CFR 820.

Responsibilities

• Ensure all Pall Medical design activities conform to Cytiva Design Control procedures.
• Provide guidance in preparation of design control documentation.
• Lead cross-functional team in conducting product risk analysis.

Skills

Medical Device Product Development

Regulatory Compliance

Communication Skills

Education

Degree in Science or Engineering

Tools

Veeva Vault Quality Management Software

Lotus Notes Database

Job description

A leading biotechnology company is seeking a Design Control Specialist in Portsmouth, UK. The role involves ensuring compliance with quality management standards for medical device development. Candidates should have a degree in a related field and significant experience in regulatory compliance for medical devices. Excellent communication skills and knowledge of ISO regulations are necessary. This is an on-site position offering a chance to make an impact in life sciences.