Back to Job SearchWe are currently recruiting a Device Development Lead to join a leading Pharmaceutical company in the Cambridgeshire area. This is an exciting opportunity for a seasoned professional to lead device development activities for medical devices and combination products (MDCPs) from concept through to regulatory approval across multiple markets.
You will manage cross-functional teams, liaise with external vendors, and ensure project milestones are met in quality, cost, and schedule. This role offers the chance to influence innovative drug delivery solutions within a collaborative and dynamic environment.
This is an initial 23 month contract and can offer hybrid working.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Device Development Lead will be varied however the key duties and responsibilities are as follows:
- As the Device Development Lead, you will lead multi-disciplinary project teams within the Devices Centre of Excellence in the development and lifecycle management of drug delivery devices, ensuring alignment with company procedures and regulatory requirements.
- As the Device Development Lead, you will coordinate activities across internal teams and external vendors, managing project scope, device specifications, design development, and validation activities.
- As the Device Development Lead, you will apply design control, risk management, and regulatory standards such as ISO13485 and ISO14971 throughout all phases of device development.
- As the Device Development Lead, you will oversee device industrialisation, manufacturing investigations, and handle supplier evaluations and assessments.
- To lead, manage, and coordinate project activities ensuring delivery on quality, timeline, and budget targets.
- As the Device Development Lead, you will support regulatory submissions, device change controls, and long-term resource planning.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Device Development Lead we are looking to identify the following on your profile and past history:
- A Degree, HND or higher in engineering or a relevant technical discipline.
- Proven experience leading multi-disciplinary teams in the development of medical devices or combination products, with at least 8-10 years in a similar role.
- Extensive knowledge of product development processes from concept to launch, including design control principles, risk management, and GMP/ISO13485 requirements.
- Demonstrated experience in preparing device sections of regulatory submissions such as BLAs, MAAs, INDs, and CTDs for global markets.
- Strong understanding of regulatory frameworks, including EU Medical Device Regulations, and current industry trends.
Key Words: Medical Devices / Combination Products / Device Development / Regulatory Compliance / Project Management / Risk Management / Design Control / ISO13485 / GMP / Cross-Functional Leadership / Innovation
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
