Applications close in 5 days
SO40, Totton, Hampshire
£45,000 - £55,000 / year
NHS Band 8A
We are looking for a Quality Assurance & Regulatory Affairs Manager (Medical Devices) to join our team at our Ultimate Healthcare site in Totton, Southampton. You will be responsible for compiling and managing technical files alongside the maintenance and development of the company quality policy and adherence to ISO13485, MDD/MDR and other appropriate standards, as necessary.
Ultimate Healthcare has tripled in size over the last 4 years to become the leading independent provider, which manufactures pressure care mattresses, hospital beds and wheelchairs.
* Manage and continuously improve the existing quality management systems.
* Ensure products conform to quality policy and adherence to ISO 13485, MDD/MDR and other required standards.
* Maintain current accreditations for QMS (ISO 13484) and CE certification.
* Ensuring all documents, procedures and work instruction are kept current and relevant.
* Manage CAPA process and coordinating root causes and corrective actions for both in-house and customer returns (RMA process) and complaints with follow up checks.
* Management of supplied products/materials quality issues. Working with suppliers to ensure issues are effectively resolved and SCAR investigations are fully documented.
* Prepare audit schedule and conduct internal and supplier audits to the approved schedule.
* Quality for the supply chain and ensure that processes, practices and records are effective to ensure the end quality of Ultimate products is to specification.
* Ensure facility and all staff working in and external to the facility comply with current Health and Safety legislation.
* Manage and deliver QMS training to all UHC employees.
* Work closely with commercial and operations team to manage and approve New Product Introduction (NPI) in accordance with NPI process, to place it on the market.
* Responsible for collating all data and creating Technical files including clinical evaluations are processed, risk assessments completed to maintain CE marking of the devices in a format consistent with applicable regulatory requirements.
* Prepare responses to regulatory authorities and Notified bodies questions within assigned timelines.
* Ensure all class I product types are registered and listed on the MHRA website.
* Stay abreast and communicate changes in regulatory requirements to management.
* Manage vigilance and reporting activities.
* Review, create product label, user manuals and promotional materials for compliance with applicable regulations and technical standards.
* You will have the following qualifications and knowledge base for this role:
* Bachelor’s degree in Science or Engineering
* Experienced and trained in ISO 13485 and experienced Regulatory affairs with working knowledge of MDD / MDR
* Working with class I and class IIa devices and strong experience in electro-mechanical devices
* Internal and /or Lead auditor
* Knowledge of standards such as ISO 14001 & ISO 45001 would be advantageous
* Be comfortable challenging staff at all levels including senior management on Quality Policies and systems and interacting with notified bodies.
* Excellent verbal and written communication skills.
* Confident at delivering training to all levels of employees using a variety of methods.
* Proven team player with the ability to use own initiative and have a "can do" attitude and be comfortable working on own.
* Highly proficient in the use of IT software.
* Excellent time management in regards to achieving deadlines and adhering to audit schedules
What we can offer you:
An annual salary of £45,000 to £55,000 per annum
Further benefits including: Up to 33 days holiday (including bank holidays plus optional 5 unpaid days), A rewards scheme – 200+ exclusive perks and discounts from leading retailers and leisure outlet, Pension Scheme with enhanced salary sacrifice option and 5% employer contribution, Life Assurance
You must have held a full UK driving licence for at least 3 years.
This role is working in a regulated activity and may be subject to an enhanced DBS disclosure.
No terminology in the advert you have seen is intended to discriminate on the grounds of age, gender, race, colour, religion, disability or sexual orientation, and we will gladly accept applications from all sections of the community