Senior Regulatory Affairs Specialist

Regulatory Affairs SpecialistThe Regulatory Affairs Specialist will support regulatory operations and process improvement initiatives across multiple business units within the medical device industry. The role involves preparing and coordinating regulatory submissions for US and EU markets while ensuring compliance with applicable regulatory requirements. The specialist will assess regulatory changes, maintain procedures, and support implementation of evolving requirements, including EU MDR. This position requires collaboration with cross functional teams to support inspections, regulatory activities, and continuous improvement initiatives.Key Responsibilities:Support regulatory affairs strategy implementation and day to day regulatory operations across multiple business units.Coordinate the development and maintenance of product registration submissions, progress reports, supplements, amendments, and periodic experience reports.Assess regulatory changes and update regulatory procedures to address evolving requirements, including EU MDR.Support internal and external inspections by coordinating documentation and collaborating with relevant stakeholders.Identify opportunities to improve regulatory affairs processes and drive improvement initiatives through completion.Collaborate with cross functional teams in a matrixed environment to maintain regulatory compliance and improve operational efficiency.Required Qualifications:Bachelor degree required.3 to 5 years of experience in medical device regulatory affairs.Working knowledge of EU MDR requirements.Experience conducting regulatory change assessments.Knowledge of US and EU medical device submissions.Experience supporting internal and external inspections.Experience working cross functionally in a matrixed environment.Experience with continuous improvement activities.Preferred Qualifications:Experience developing and updating regulatory procedures and work instructions.Experience implementing regulatory process improvements across multiple business units.Benefits:The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)