Medical Device Specialist

Job Description:

As a Medical Device Specialist, you will be preparing dossiers for the batch verification of medical devices. This will involve reviewing batch deviations, change controls and test results.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at (COMPANY NAME) on our webpage Life at (COMPANY NAME) | (COMPANY NAME)

Key Responsibilities include, but are not limited to:
* Liaise with External Quality, Sites, Manufacturers, and other groups for co-ordination of batch verification.
* Support the Associate Director, Medical Devices in compliant batch review and ensure timely escalation of any issues identified,
* Review associated records and documentation, including deviations, changes and tests.
* Raise and investigate deviations relating to medical devices processes including batch verification.
* Conduct activities to support Quality Systems (including ISO 13485) including:
* Quality meetings
* Deviation management
* Customer Complaint and Adverse Event/Serious Adverse Event management and trending
* Key performance indicators generation and reporting
* SOP / Technical report preparation and approval
* Conduct/participate in audits / self-inspections
* Periodic Product Reviews
* Processes effectiveness checks
* Ensure batches verified are maintained, and dossiers and samples archived in accordance with local SOPs and MDR 2017/745 requirements.
* Effectively communicate with Supply Chain Hubs, Local Operating Companies, manufacturing sites, External Supply managers and other stakeholders in the business.
* Present data on (COMPANY NAME)'s behalf during regulatory inspections of the team.

Why you?

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals,
* Educated to GCSE/A Level standard (or equivalent). May hold a degree in a relevant science subject.
* Working knowledge of medical device, GMP and GDP regulations and experience in manufacturing site operations, batch record review, quality data review and operational quality requirements.
* Able to present on aspects of the medical device certification process where role holder has responsibility during regulatory inspections.
* Experienced in application of GPS thinking and tools and knowledge of performance measures
* Understanding of quality management principles and demonstrated experience of quality documentation review.
* Knowledge and experience of self-inspection processes and participation experience..

Preferred qualifications:
* Understanding of ISO 13485 and MDR 2017/745 compliance.
* Experience of using systems such as Veeva Quality Doc and Veeva QMS and Team Sites.

Closing Date for Applications - 14th May 2024 (COB)

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.

At (COMPANY NAME), we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

Find out more:
Our approach to R&D.
Why (COMPANY NAME)?
Uniting science, technology and talent to get ahead of disease together.

(COMPANY NAME) is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making (COMPANY NAME) a place where people can thrive. We want (COMPANY NAME) to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@(COMPANY NAME).com or 0808 234 4391.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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(COMPANY NAME) does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact (COMPANY NAME)'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to (COMPANY NAME). The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and (COMPANY NAME). In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of (COMPANY NAME). (COMPANY NAME) shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure (COMPANY NAME)'s compliance to all federal and state US Transparency requirements. For more information, please visit (COMPANY NAME)'s Transparency Reporting For the Record site