Quality Management Systems (QMS) to ISO 13485:2016 compliance including Class I, IIa, IIb and Software as a Medical Device (SaMD) Information Security Management Systems (ISMS) in compliance with ISO 27001:2013 Technical File Summary Reports to UK MDR 2002 and the MDR (EU) 2017/745 including Class I, IIa, IIb and SaMD FDA Submissions including SaMD and Medical Devices including Traditional 510k, 513g and Enforcement

Worked with a number of medical device clients including Software (SaMD) to develop and implement the following:Quality Management Systems (QMS) to ISO 13485:2016 complianceTechnical File Summary Reports to UK MDR 2002 and the Medical Device Regulation (EU) 2017/745 - in accordance with the 'STED' formatting structure Development of supporting documentation for Technical Files such as: Risk management plans / hazard identification / FMEAs / risk management final reports to ISO 14971:2019Essential requirements evaluations to Annex I of UK MDR 2002GSPR evaluations to Annex I of MDR 2017/745Device classification according to both the UK and EU MDRsPost-market surveillance reports for many medical device 'families' Device labelling / artwork in compliance with CE marking requirements

 Quality Management Systems (QMS) to ISO 13485:2016 compliance including Class I, IIa, IIb and Software as a Medical Device (SaMD) Information Security Management Systems (ISMS) in compliance with ISO 27001:2013 Technical File Summary Reports to UK MDR 2002 and the MDR (EU) 2017/745 including Class I, IIa, IIb and SaMD FDA Submissions including SaMD and Medical Devices including Traditional 510k, 513g and Enforcement Discretion MDSAP Projects, PMS and CER Reports Development of supporting documentation for Technical Files such as:- Risk Management Plans / Hazard Identification / FMEAs / Risk Management Final Reports to ISO 14971:2019- Essential Requirements Evaluations to Annex I of UK MDR 2002- GSPR Evaluations to Annex I of MDR 2017/745- Device classification according to both the UK MDR 2002 and MDR (EU) 2017/745 including SaMD- Device labelling / artwork including SaMD in compliance with CE Marking requirements and ISO 15223:2021- UDI / EUDAMED Project Management for device registrations required for European market access- EU Authorised Representative (EU Rep) and UK Responsible Person (UK RP) Services - NHS Market Access including DTAC, DSPT and DCB0129 - ISO 13485:2016 Certified Internal Auditor- GAP Analysis and remedial work to ensure technical documentation compliance with relevant international standards- GAP Analysis and remedial work in relation to Notified Body reports following ISO 13485 and/or ISO 27001 Certification or Surveillance Audits

• Managed the marketing for the group including all activity within the marketing department. • Responsible for managing digital marketing projects for the group including the agile design, production and launch of the following: two new websites, end user app, consultant portal and the introduction of the marketing automation strategy including HubSpot/MS Dynamics CRM integration.• Managed digital marketing activity including social media, SEO, SEM, PPC and content marketing to support the business objectives.• Work closely with Managing Director/Board of Directors to develop a cross-platform integrated marketing strategy which is conducive to the company’s goals and objectives.• Ensure digital marketing projects hit deadlines and are within specified budgets; continually analyse effectiveness utilising tools like Google Analytics to track and improve ROI.• Responsible for the creation and publication of all marketing material and documentation including social media messaging/assets, white papers, videos, infographics, brochures, webpages and blogs.• Supporting different sales functions by assessing and improving content led digital lead generation campaigns providing MQLs, analysing results obtained and using this information to constantly improve campaigns ensuring optimal results are attained.• Responsible for promoting frequent and timely positive media coverage across all media channels available (working with both PR and digital marketing agencies) and counteracting any negative publicity including introduction of an employee advocacy programme utilising platforms such as Glassdoor and the company LinkedIn pages.• Maintaining effective internal communication including the management of company Intranet and SharePoint document control resources to ensure all the relevant functions are kept informed of marketing objectives/achievements.

One Year Fixed Term Contract• Have overall responsibility for devising and delivering the company’s marketing plan, including all marketing activities for our numerous imprints including books, e-books and digital resources• Directly responsible for one staff member and the management of external agencies including PR, social media and design• Designed, produced and launched three fully e-commerce ready websites for our key sub-brands• Responsible for the design, delivery and analysis of all digital marketing activity including content, SEO, PPC and social media promotion.• Ensured all marketing projects were delivered cost effectively and to agreed deadlines.• Visiting key accounts and strategic partners to develop and implement co-operative digital marketing campaigns and effective sales promotions

Working with business owners and their senior teams, using both personal experience and the ActionCOACH process, we work together to drive the business forward. Whether its a challenge or an opportunity we work on both who you need to "be" as well as what you need to "do" to achieve your desired outcome.

• Responsible for development and implementation of company marketing plan, including all marketing activities across both UK and Europe• Delivered a number of key digital projects including a new website, health app (working with the NHS and automated outbound digital marketing campaigns• Managing internal design, website, database management and administration team• Management of external agencies including PR, sales promotion, social media and design/advertising• Setting and managing budgets, ensuring all projects are kept within budget and cost savings made where possible• Development and delivery of all ATL/BTL activities for both automotive and general publishing titles supported by POS and selling materials for integrated sales/marketing • Working with key internal stakeholders from NPD to NPI with responsibility for devising and delivering the agreed marketing plan • Visiting key accounts (including Amazon, Halfords and WH Smith) to plan and execute future sales promotions and marketing support

• Working with product and sales managers on-site at Coca-Cola to deliver marketing activities across the brand portfolio through various distribution channels• Managing sales promotions including design, production and delivery of POS for all Coca-Cola brands within the food and leisure channel including Subway, Sodexo, Tussauds Group, Bourne Leisure and Vue Cinema• Creation and delivery of bespoke POS and POP solutions to support both national promotions and new product development • Managing the design and delivery of innovative in store display solutions for key customers• Working on behalf of Coca-Cola as key marketing contact liaising direct with clients such as Tesco, Asda, Sainsbury’s, Somerfield and Woolworths

• Design and production of seasonal showroom graphics in line with business strategy, sourcing product, models and locations, styling and co-ordination of photo shoots• Producing bespoke POS and visual merchandising guidelines for customers ensuring consistent branding across all distribution channels• Creating trading period action packs for Wholesale accounts, detailing display guidelines for interiors and windows, product information and advertising information• Event management including conferences for around 600 delegates, involving production of videos, presentations and other support materials

• Managing a range of established accounts including retail outlets, scientific and education institutions, zoos and animal parks • Co-ordinating worldwide exhibitions and trade shows including booking venues and the design and production of stands and promotional materials • Working in partnership with clients on new product development projects• Responsible for research, design and production of new packaging: POS materials, advertising, promotional activities and technical product information