Job Title: Quality Compliance Manager Company/Division: A global medical device and Medicine manufacturer Location: Oxford, Newbury, Swindon, Gloucester area Reports to: Director of Quality Mercury Hampton is exclusively retained on this vacancy. The Role: We are working with a well-established manufacturer and distributor of medicines, medical devices, and general pharmacy products that have a rich history spanning over a century. Their commitment to quality and compliance has made them a global player in the industry. We are seeking a dynamic and experienced Quality Compliance Manager to join the business. As a key member of the Quality Compliance Department, you’ll play a crucial role in maintaining and supporting company-wide compliance with ISO 13485:2016 and other relevant quality management systems. A big part of this position will be to lead the transition from the Medical Device Directive (MDD) over to the new Medical Device Regulation (MDR) along with the following responsibilities: Maintain the Quality Management System in compliance with ISO 13485 Act as the Quality Representative for business. Maintain and continually improve the quality processes required to ensure compliance, effectiveness, and continual improvement Ensure compliance with the Medical Device Directive Manage the transition to compliance with the Medical Device Regulation Support maintenance of product compliance to CE marking requirements including transition to MDR Co-ordinate management reviews, post market surveillance, DHF audits and independent design reviews Manage and control the Master Document List Manage EU medical device complaints including vigilance assessments Manage day-to-day product quality including deviation and CAPA resolution, CMO management including supplier notifications of change and supplier correction action reports and change controls Generate documentation in line with Quality Management System certification including risk management, root cause analysis, correct and preventive action and change management Provide support to the Operations Team to generate documentation relating to the manufacture of medical products Take responsibility for the generation of documentation relating to the technical files and dossiers for medical products Manage internal and external audit support including site readiness Continually develop, monitor and report on the metrics needed to gauge the performance of the Quality Management System Establish and drive successful fulfilment of quality system objectives; monitor and report on progress to these objectives Provide the point of contact for all regulatory communication including incident reports, audits, registrations etc. Communicate with customers on regulatory issues and responding to complaints and adverse event reports Communicate with suppliers including performance review and auditing Support the Commercial Department with regulatory advice and information and supporting the registration of both medicines and medical devices in overseas territories Generate product registration documentation and report directly into the group Managing Director and Commercial Team on the progress of registrations Co-ordinate with international teams, distributors and competent authorities to ensure timely licence approvals Keep up to date with and prepare briefing summaries on new regulations and advice on regulations Provide relevant in-house training including awareness training e.g. GMP/GDP Support the department’s Quality Control & Quality Assurance activities and deputise for the Quality Compliance Director Undertake any duties appropriate to the role which supports the business as and when required Person Specification: To be successful as the Quality Compliance Manager you’ll have the following skills and experience; Education and Experience Required: Education up to degree level or provern experience within Medical device, Pharma or relevant industries. Experienced with managing and maintaining a variety of Quality standards such as ISO 13485, ISO 14971, 21 CFR 820 and MDR requirements Experience in working with regulated medical products Evidence of leadership experience Experience of working in MedTech with a solid and demonstrable understanding of the associated regulations such as IVDD/IVDR, ISO 13485, FDA 21 CFR 820, ISO 14971 etc. Solid working knowledge of Regulatory Affairs Deep and current knowledge of Quality Management principles Evidence of training or experience in internal auditing to ISO9001:2015 and/or ISO13485:2016 Understanding of Cleanroom operations and environmental control Skills and Abilities Required: High level of integrity and openness combined with a commitment to good governance Excellent communication skills Strong project management and organisation skills Strong problem solving skills Ability to meet target deadlines Excellent document writing skills with high attention to detail Committed to team-working with the ability to work effectively and lead collaboratively across teams Skilled at managing ambiguity, influencing without authority and driving for and delivering results Mentoring skills with a respectful attitude and an eagerness to invest in others Ability to effectively articulate (verbally and in writing), and translate to enable understanding, key information, data sets and research conclusions to both technical and non-technical personnel in an inclusive way Strategic thinker The Package: As the Quality Compliance Manager you’ll receive a starting salary of £60,000 - £65,000 benefits. The working conditions for this role is industry leading and are as follows: 9-day fortnight working pattern; Week 1: Monday – Thursday 08:00am – 17:15pm Week 1: Friday - 8.00am – 13:00pm Week 2: Monday – Thursday 08:00am – 17:15pm Week 2: Friday: OFF – nonworking day This role also offers hybrid working meaning you’ll have the opportunity to work two days from home each week. To Apply: This is an excellent opportunity for an experienced Quality Compliance Manager to join a busy manufacturing business with the opportunity to progress. Please apply with your CV and a cover letter explaining why you are the ideal candidate for this role.