The mission of the Quality and Regulatory Affairs department is to enhance CliniMed's and SecuriCare's business and values by ensuring that all commercial activities are compliant with the relevant standards and systems. Overall objectives of the department are set annually in line with the business' strategic direction. These will be based around the following principles and tasks.
- To assist in improving the quality of CliniMed's and SecuriCare's activities across the business by supporting managers in all departments from new product development and marketing through to supply chain and sales, customer service and distribution.
- To provide regulatory expertise to the board of directors and managers within our organisations contributing to sound decision making and minimising business risks.
- To ensure that business activities conducted are in compliance with the ISO 9001 (General QMS), ISO 13485 (Medical Devices QMS), ISO 14001 (Environmental Management System), Medical Devices Directive (current) and Medical Devices Regulation (in future), Wholesale Dealers Authorisation for medicines, Good Distribution Practice (GDP), Labour Standards Assurance Scheme (LSAS) all applicable national regulations and in compliance with our SOPs.
- To work closely with the New Product Development Team to bring new products to market, either under our own CE mark or through distribution or similar agreements.
- To manage communication and approvals with Competent Authorities eg. MHRA) and Notified Bodies (eg. LRQA).
You will behave in a professional manner at all times and you will build professional relationships with customers and key opinion leaders that will enhance the Company's quality image.
- Educated to degree level in a scientific, engineering or relevant discipline
- Proven Quality & Regulatory experience from medical devices or pharmaceutical/healthcare/cosmetics fields
- Expert knowledge of The Medical Devices Directive (MDD) and Medical Devices Regulation (MDR), ISO13485, ISO9001, ISO14971
- Qualified to be the Person Responsible for Regulatory Compliance in line with Article 15 of the Medical Devices Regulation
- Experience of internal and external auditing
- Experience of leading a team, skilled as a coach and advisor to support the professional and personal development of team members
- Experience interpreting, implementing and communicating changes in Regulatory policy and Quality standards
- Experience in developing quality and regulatory strategy
- Excellent written communication and presentation skills
- Ability to engage and influence internal and external customers and champion a positive quality culture across the business
- Ability to prioritise, plan and organise workload and work to deadlines
- Highly IT literate
- Highly numerate with an excellent level of attention to detail
- Qualified to act as a Responsible Person in respect of Good Distribution Practice
- Experience with ISO14001
- Able to demonstrate knowledge of the following regulations and directives:
- The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013
- Classification Labelling and Packaging Regulations
- General Data Protection Regulation
- The Health Service Products (Provision and disclosure of information) Regulations
- The Health Service Medical Supplies (Costs) Act
- Falsified Medicines Directive
- The Human Medicines Regulation 2012
- MHRA Blue Guide: Advertising and promoting medicines in the UK