Regulatory Operation Manager - Medical Devices City: Chachoengsao **We are Reckitt** Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. **Role Summary:** Responsible for the management of medical devices dossiers involving the compilation, preparation, review, approval and submission of regulatory documents to Notified Bodies and where applicable Health Authorities to support the launch of new innovations and roll outs of new and existing products. **Role & Responsibilities:** + Responsible for the creation, delivery and maintenance of medical device regulatory dossiers, driving consistency & direction and guaranteeing the appropriate resources and expertise is applied in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings and existing pipeline compliance. + Managing a complex and diverse set of regulatory requirements and landscape overview across multiple markets to enable medical device dossier generation of all new global pipeline delivery and roll outs and enable the most efficient registration of detail to simplify post-launch maintenance of the medical device portfolio for all Reckitt business units. + Ensuring your teams work in collaboration with other X-functional technical functions like Safety, Quality and R&D as well as other RAS areas and local teams to define documentation requirements and data gathering. + Ensuring through dynamic resourcing that the dossiers are delivered as per plans and that appropriate and aligned prioritization is implemented. This includes working in collaboration with the Regulatory Strategy team and LRA in understanding country insights, requirements and upcoming legislative impacts. + Provide advice and guidance to cross functional stakeholders on European regulatory requirements as required. + Review and input into product data to deliver best in class regulatory dossiers according to regulatory requirements. + Ensure medical device dossiers are compliant for registration requirements and changing legislative requirement are effectively considered and implemented where applicable. **Qualifications:** + Bachelor’s degree of in a relevant scientific, pharmacy, medicine, chemistry, biology or related field. + Al least 10+ years relevant experience in regulatory affairs or operations. + Strong understanding of regulatory requirements and guidelines. + Experience in leading and managing regulatory projects, including coordinating global submissions. + Good command of written and spoken in English. **What we offer** With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy. **Equality** We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. **Job Segment:** Medical Device, Pharmacy, Counseling, Nutrition, Medical, Healthcare