In this role you will
· Use problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges.
· Support device development work streams for R&D combination product development projects.
· Work across platform devices, co-ordinating development activities and managing platform documentation.
· Collaborate with multi-disciplinary teams across GSK and international sub-contractors.
· Facilitate risk assessments (e.g. user, design or process risk assessments)
· Participate in design reviews at critical stages of device development.
· Participate in device development project team meetings, ensuring development deliverables are met.
· Compile device development documentation including Design History Files and Risk Management Files.
· Co-ordinate testing activities (e.g. verification, validation, Design of Experiments, robustness studies) to ensure device safety and performance.
· Work closely with the manufacturing organisation to ensure that methods and processes are transferred successfully for commercial production.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
· 1st or 2:1 in Mechanical Engineering, Biomedical Engineering or related degree.
· Experience of medical device or combination product development.
· Experience of working within device regulatory requirements and industry processes such as design controls (21 CFR 820.30), EU MDR 2017/745, risk management (ISO 14971), QMS (ISO 13485) and GMP.
· Ability to quickly establish relationships with internal and external stakeholders.
· Strong communication skills.
· Thrives in fast paced environments.
Experience Inhaler and respiratory
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
· Experience in the regulatory pathways for combination products.
· Experience with global submissions, agency interactions and authoring dossiers.
· Excellent written and verbal communication skills
· Strong time management/organisational skills
· Evidence of team working skills and flexibility
GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose – along with our goal of being one of the world’s most innovative, best performing and trusted healthcare companies – helps us attract some of the best and brightest minds in the world.
We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.
We want our company to be a place where diversity of people and thought is valued everywhere and where we’re all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day.