QA Medical Devices Specialist

Job description

Develop and maintain a quality management system which complies with ISO 13485, MDR, MDD and other applicable medical device standards and regulations. Contribute to the maintenance of the Otsuka Europe quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate, and that Otsuka Europe fully complies with all relevant medical device legislation and industry recommended practice. Quality Assurance -Develop and maintain the quality management system to assure compliance with ISO 13485, MDR, MDD and other applicable device standards, in addition to GMP and GDP requirements. -Fulfil the role of Post Marketing Surveillance (PMS) Manager, including the maintenance of the process and procedures related to this activity. -Support the Person Responsible for Regulatory Compliance (PRRC) with a view to assuming that role. -Implement the relevant processes and procedures to ensure the PRRC activities can be fulfilled in a complaint manner. -Act as subject matter expert in relation to medical devices and give guidance and direction to the QA team in order to ensure compliance with the required medical device legislation. -Assist in maintaining the system for document control, so that the current local and regional SOP systems are managed both in hard copy and electronically. -Maintain documentation archiving systems. -Prepare and maintain GMP documentation such as standard operating procedures. -Conduct training sessions on QA systems as required. -Manage and maintain a system for product complaint handling ensuring timely completion and reporting. If necessary, assist in any product recall and address Field Safety Corrective Actions in a timely manner. -Collect, collate and compile data for periodic product quality reviews, including preparation of reports. -Plan, implement and perform internal quality audits. -Monitor and report on product non-conformities. -Manage and maintain systems for change control, deviation and CAPA. Regulatory -Liaise with regional Regulatory team to ensure compliance with applicable requirements -Provide support and advice relating to the manufacturing and technical content of the Company’s product licences and submissions -Ensure that the requirements and conditions of the Company’s product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures. Additional Activities -Provide additional support to the QA Department through assisting in -Implementation of variations -Writing quality agreements Assist on vendor audits if necessary Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organisational needs as necessary. Otsuka is an equal opportunity employer and any applicant who meets the candidate profile is encouraged to apply. Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.