Senior Regulatory Affairs Specialist

Working at Freudenberg: We will wow your world! Responsibilities: Assists in the completion and assembly of regulatory submissions (both international and domestic). Maintains regulatory files including submissions, technical files, etc. Assists in regulatory body, internal & external audits, product recalls, Vigilance and MDR reportability, as necessary. Interfaces with customer service and engineering on customer complaints and complaint investigations. Ensures customer complaints, MDR’s and global vigilance reporting are addressed in a timely manner according to the risk level per company and regulatory standards. Assists customer service and quality team in improving the customer complaint process and procedures. Management of domestic and international standards, directives, regulations, etc. for gap analysis according to the latest revision. Independently handle problems that arise within area of responsibility. Able to assist Freudenberg Medical departments in gathering data or special assignments with limited assistance. Performs in-depth review of regulatory data/information and provide oversight of query resolution and database to Supervisor/Manager. Able to change priorities when directed by Supervisor/Manager. Qualifications: As Per Job Spec ‎ ‎ The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Medical Ireland Ltd.