Design Control Specialist

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

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Design Control Specialist is responsible for establishing and maintaining the Design Control process for devices, filters and associated separation systems for global Pall Medical applications within the guidelines of an ISO 13485 and ISO 9001 compliant Quality Management System, and where relevant FDA 21 CFR 820, MDSAP and the EU Medical Device Regulation (MDR)

This position reports to the Director Medical Technology and is part of the Pall Medical Technology Team in Portsmouth, UK and will be an on-site role.

What You Will Do

• Responsible for ensuring that all Pall Medical design activities conform to Cytiva Design Control procedures throughout the product lifecycle, within the guidelines of ISO 13485 and ISO 9001 compliant Quality Management System, and where relevant FDA 21 CFR 820, MDSAP, and the EU Medical Device Regulation (MDR)
• Provide guidance to the Pal Medical Research and Development and Product Engineering teams in the preparation of design control documentation throughout the product lifecycle, including the preparation of Design History Files (DHFs)
• Responsible for leading a cross functional team in conducting product risk analysis to ISO 14971 and implementation of risk management strategies throughout the product lifecycle of Pall Medical products
• Work with cross functional technical teams to develop protocols for the verification and validation (V&V) testing of prototypes and finished products
• Contribute to the development and improvement of design and development processes to enhance efficiency and ensure product quality

Who You Are

• Degree in Science or Engineering related subject or equivalent experience
• A strong background and significant experience within the field of Medical Device Product Development/Quality/Regulatory is essential
• In-depth knowledge of regulations and standards, such as ISO 13485, ISO 14971, FDA 21 CFR 820, and the EU Medical Device Regulation (MDR)
• A strong understanding of the overall design control process, including design inputs, outputs, verification, and validation
• Excellent written and verbal communication skills are necessary for effective collaboration and documentation.

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel Limited travel to other Cytiva sites within UK and Europe

It would be a plus if you also possess previous experience in:

• Lotus Notes Database management of Design History Files and other design documentation
• Veeva Vault Quality Management Software

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.