Role - Senior Regulatory Affairs Manager / Compliance - Technical files -EU MDD/MDR Location - Midlands Hybrid role - 2-3 days in the office. Do you want to spend your working time making a difference in the world around you? Are you passionate about Healthcare and Life Sciences? If so, then a career with this company in Regulatory Affairs could be a great fit for you. About Us: We help our customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The mission of the Regulatory Affairs function is to implement efficient and effective processes to initially obtain and then maintain clearance to market products in support of global business plans. This includes meeting registration and/or submission requirements in the US and international markets and working with product acquisition or development teams to ensure these requirements are met. This group also identifies and supports Quality and Regulatory Compliance needs of the Corporation. We are currently recruiting for a Senior Regulatory Affairs Manager to support our Regulatory function This is a Hybrid position WHAT IS INVOLVED Set up a system to standardize, track and store EU MDR Technical Files for manufacturing facilities across the Corporation Coordinate with R&D and Quality, in line with procedures, to upgrade and maintain technical documentation in accordance with the EU MDR for devices subject both to self-declaration and EC certification through the Notified Body (BSI). Review all technical documentation and CE marked product labeling to ensure label formats, product claims, indications for use and instructions for use are appropriate and approve for Regulatory Affairs. Identify and keep up to date with EU MDCG, BSI & other guidance applicable to the EU MDR, as well as vertical and horizontal standards. Take the lead supporting RA, R&D and Quality staffs with interpretation of specific requirements re: product standards and guidance documents. Coordinate submission of applications for EC certification, participate in Notified Body Technical File audits in collaboration with senior RA colleagues for assigned manufacturing facilities and effectively interface with Notified Bodies as necessary to address certification related issues. Report to management concerning current, pending, and re-certification under the EU MDR. Identify and take action on any unexpected delays; initiate re-certifications in a timely manner to avoid disruption in product availability. Develop sound global regulatory strategies for new products. Identify and communicate applicable regulatory requirements to Regulatory Affairs management and business partners from the start of product development through qualification testing, the submission/registration process, and as changes occur or new requirements are identified. Provide regulatory guidance and support to project teams and internal customers to support new product development and existing product lines in support of EU MDR requirements. Responsible for maintaining understanding of and compliance with all current active corporate procedures applicable to their job functions. Maintain conduct in accordance with the principles of the Code of Business Conduct and comply with all Company policies. Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized. Conduct daily activities of assigned job responsibilities and projects as assigned. EXPERIENCE REQUIREMENTS Minimum of 5-10 years professional experience in regulation of medical devices, specifically including significant experience in Technical file compilation under the EU MDD/MDR. Minimum 5 years management experience Bachelors degree in a scientific, engineering or legal subject. Government agency and/or legislative experience required Must have the ability to build relationships and influence decision makers. Capability to interact effectively and credibly at senior levels. Extensive understanding of medical device industry, in particular the workings of the regulatory and legislative environment around the world. Comprehension of industry developments and changes in the political environment. Extensive network-building and contact experience. Demonstrated excellence in the following: communications skill, listening skills, interpersonal skills, cross BU team coordination, planning, research, diplomacy, advocacy and sales skills. Ability to operate in a business driven model providing quick, salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses.