Job Title:Senior Regulatory Affairs, Belgium:LJob Category:PermanentDescription:Schedule:Full Time, PermanentAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says its the best of both worlds.TalentSource Life Sciences (the sponsor:dedicated division of CROMSOURCE), is searching for a Senior Regulatory Affairs to join one of our clients, one of the most innovative pharmaceutical companies in the world.CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client:trust environment with their client counterparts.Scope of the role:Medical Device Regulation (MDR) and associated secondary legislation within the Cardiovascular and Specialty Solutions Business Units.Main Job Tasks and Responsibilities:Provides strategic guidance to Cardiovascular and Specialty Solutions (CSS) related to regulatory requirements and develops recommendations pertinent to the Franchise in accordance with regulations and relevant guidelinesEnsures the timely execution of regulatory implementation activities and associated projectsProvides clear and timely communication of new and changing requirements to the Franchise regulatory teamsEducates Franchise Associates on EU requirements and integrates those requirements into Franchise proceduresOrganizes and maintains reporting schedules, trackers, andsystemsDevelops and sustains relationships with Research Associate affiliates, contributing to the development and execution of local strategy. This includes planning, prioritization, and preparation of responses to regulatory agencies questions and other correspondenceDrives consistency across all businesses within Cardiovascular and Specialty Solutions (CSS) and across MedTech for technical documentation creation and adherence to proceduresSupports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges, and process improvements throughout the programSupports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall scheduleDevelops and maintains constructive and cooperative working relationships with business functions in the organizationIdentifies and facilitates continuous improvement activitiesRepresents Cardiovascular and Specialty Solutions in various internal forumsDevelops solutions to a variety of problems of extreme complexity in which data analysis requires an evaluation of intangible variablesWrites, reviews, and revises company SOPs as required, recommending adjustments to processes to improve efficiency or align with compliance requirementsResponsible for communicating business:related issues or opportunities to the o next management levelResponsible for ensuring that subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good conditionResponsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and proceduresPerforms other duties assigned as neededEducation and Experience:University degree in Science, Importante empresa, Technical or Biomedical field or Law (or equivalent degree with adequate experience)6:8 years of experience in Regulatory Affairs or other related disciplines in the medical device or pharmaceutical industri
