Quality & Regulatory Affairs Manager
Our client, a leading healthcare organisation are currently recruiting for a Quality and Regulatory Affairs Manager to join their team on a permanent basis. As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the organisation. You will manage the department effectively to ensure compliance, continuous improvement and to ensure product quality and customer satisfaction.


Responsibilities

• Provide Quality & Regulatory strategic direction, training and support to the organisation
• Ensure business activities are conducted in compliance with the regulations and standards applicable to the business and product range
• Lead the Quality Management Systems including Documentation, Complaints Management, CAPA and Management Review
• Responsible for the overall development, implementation, and maintenance of the organisation’s Quality Management System (QMS) for all of its product classifications; medicinal, medical device, cosmetic, food supplement products
• Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation
• In collaboration with the Management Team, drive continuous improvement and best practices
• Interact with regulatory agencies, industry organizations, consultants, suppliers, legal counsel and health care professionals
• Responsible for ensuring adherence to all external regulatory requirements – MDR 2017/745 and 21 CFR 820
• Manage internal and external audits
• Maintain and follow up CAPAs
• Responsible for the implementation of Quality Agreements with partners
• Enhance a compliance culture throughout the organisation
• Maintain an ISO13485 Quality System incorporating the company’s existing medicinal QMS
• Prepare and maintain documentation in compliance with the appropriate regulatory requirements
• Act as our Responsible Person for Medicinal Products under the company’s Wholesale Distribution Licence (WDA)
• Work to act our as RPI for medicinal products in the UK and Northern Ireland
• Adapt existing procedures and documents that best meet the requirements of QS and the workflow within the Company. Create new Standard Operating Procedures, as required
• Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and Regulatory requirements
• Interact with Regulatory Bodies to provide information on requirements for Certifications and approvals
• Provide Quality and Regulatory inputs into Clinical studies
• Oversee the Company complaints procedures and ensure that Complaints are managed appropriately across the business
• Provide technical leadership and vision through the interpretation of new and emerging international regulatory trends pertinent to local business needs and develop and implement strategies and projects to optimize regulatory performance
• Responsible for final sign-off on all product labels & package inserts for products
• Provide regulatory advice and perform regulatory assessments of business development opportunities
• Work through the Brexit requirements for our business across the different classes of product

• Third level qualification in Quality & Regulatory Affairs. An additional qualification in Life Sciences is desirable
• At least 8 years post-graduation experience in Quality & Regulatory environment with at least 5 years at a similar level
• Experience in management of Quality Systems in a Medical Device/Pharmaceutical Industry
• Excellent knowledge of ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions
• Experience dealing with Notified Bodies relating to Medical Devices
• Experience In technical file writing
• Proven track record of regulatory submissions of technical files
• Experience in CAPA system management
• Six Sigma training desirable
• Regulatory experience and knowledge in the following areas; medicinal, medical, cosmetic and food supplement
• GMP Experience
• Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment
• Good supervisory, technical writing and investigation skills
• Excellent communication and inter-personal skills
• Strong planning and organizational ability
• The ability to carry out work in a fast-paced organisation
• Ability to influence peers and colleagues and ensure that they understand with great clarity what is expected from them from the quality and regulatory department. Ensuring colleagues understand the why are supportive of the needs of the Q&R department