Regulatory Affairs Specialist,

Responsibilities:Preparing documentation for international regulatory registrations.Preparing technical documentation to compliant to MDD and EU MDR.Defining worldwide regulatory requirements are necessary for regulatory approval of products.Participating in cross functional teams as regulatory lead.Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages.Authoring submissions, researching requirements, setting priorities, and maintaining project schedules.Providing guidance and oversight to team members related to regulatory compliance.Reviewing marketing literature for compliance with applicable regulations.Executing on additional responsibilities as defined by management.Act as a Subject Matter Expert (SME) to support internal and external audits.Requirements:Bachelor's degree in science, Engineering, or other relevant discipline.Minimum 5-8 years' experience in Regulatory Affairs in the medical device industry.FDA, EU, Health Canada, and international registrations experience.Working knowledge with quality system regulations and guidelines.Ability to develop clear, concise, and timely oral and written reports.Great communication skills with all levels of personnel.High level of organization and planning skills.Working knowledge of medical devices, procedures, and terminology.Drug-combination experience a plus.