Regulatory Affairs Specialist Who is Drive DeVilbiss Drive DeVilbiss has become a leading manufacturer and supplier of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 80 countries around the world. Leading the World with Innovative Healthcare Solutions that Enhance Lives Summary (Major Purpose of the Role): At Drive DeVilbiss Healthcare we put the customer at the heart of everything we do and we take personal responsibility for exceeding our customers expectations. Our four principles underpin everything we do and we will expect you to embody them in everything you do. The values are: Integrity We lead with respect, loyalty and trust. Intent We hold ourselves accountable for our actions and when it is not working we fix it. Capability We listen, challenge and continuously improve. Results We will be measured by our results. In your role we will expect you to ensure that products designed, manufactured, imported or distributed by Drive DeVilbiss Healthcare meet the requirements of applicable UK, European and/or international regulations and have associated technical files in place. Main Activities/Responsibilities: The Regulatory Affairs Specialist is part of the Regulatory Affairs department at Drive DeVilbiss Healthcare. The role consists of the Regulatory Affairs Specialist reporting directly to the Head of international regulatory affairs and compliance. The role is a home-based position but there will be the need to come to head office as required. The employee is expected to self-manage on a day to day basis using their own initiative. The employee is also expected to coordinate with other regulatory affairs personnel, the quality team and the design team, along with the need to liaise with other departments when necessary. To create medical device technical files from scratch, ensuring full compliance to the EU MDR and/or associated international regulations, as required. To perform technical file reviews, ensuring full compliance to the EU MDR and/or associated international regulations, as required. To support/create/oversee/review the necessary supporting documents for medical device technical files: Test and evaluation reports. Clause compliance reports. Risk management files. Usability engineering files. Clinical evaluation reports. Post market surveillance reports. General safety and performance requirements. Ensure good housekeeping practices are maintained in the department at all times. Providing customer (internal or external) support in regards to regulatory affairs related queries. Ensure confidentiality on all matters relating to employees and information obtained during the course of employment. Competencies: Determined, enthusiastic and self-motivated. Ability to plan and organise workload. Good time management. Ability to maintain concentration and not easily distracted. Applies care and attention to detail in all aspects of role. Need for diligence. Need to be highly organised and methodical. Report writing and presentation skills to be of a high quality. Achievement orientated. Ability to perform effectively and efficiently under pressure. Ability to work independently and make decisions but to know when to ask for support and guidance. Manages assigned workload and has the ability to adapt own workload to sudden changes in requirements. Work consistently delivered on time and of a quality demanded of the requirement. Willing to put forward suggestions to improve processes. Open to change and willingness to adapt to new business needs. Appropriate and positive internal communication. Ensuring priorities and met. Excellent interpersonal and communication skills. The ability to work both alone and in a team based environment. Ability to persuade, influence and negotiate effectively at all levels. Education and Experience: Class I medical device experience or higher Essential. Technical file creation experience Essential. EU MDR knowledge Essential. UK MDR 2002. EU machinery directive. EU RoHS directive and/or UK equivalent regulation knowledge. EU REACH regulation and/or UK equivalent regulation knowledge. Clinical evaluation experience. Post market surveillance experience. Risk management file experience. Usability engineering file experience. General report writing experience. Working with British, European and international standards. Working knowledge of Microsoft Office package. Why Apply to Drive DeVilbiss Competitive Benefits including company sick pay, 26 days annual leave rising to 28 ( Book Your Birthday Off Work and the option to buy/sell/carry over annual leave), pension, Employee Assistance Programme, Bike2Work, free onsite parking, long service recognition, staff discount on our products and access to Perkbox (our benefits and rewards platform). Equal Opportunities Statement: Drive DeVilbiss is an equal opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. We ensure that to ensure that no candidate receives less favourable treatment on the grounds of race or colour, nationality, national or ethnic origin, sex, marital status, religion, age, sexual orientation or disability. Drive DeVilbiss complies with applicable legislation governing non-discrimination in employment in every location in which the company has facilities. Selection criteria and procedures are regularly reviewed to ensure that individuals are treated on the basis of their relevant merits and abilities. All successful candidates will be required to prove their eligibility to work in the UK, as well as accurate reference details covering their recent employment history. Please note some roles are also subject to an Enhanced DBS check. REF-220 615 ADZN1_UKTJ