Regulatory Affairs Specialist IV

A company is looking for a Regulatory Affairs Specialist IV. Key Responsibilities Develop and implement global regulatory strategies and prepare submissions for product registrations Provide regulatory input throughout the product lifecycle and support product development teams Participate in audits and inspections while ensuring compliance with quality management systems Required Qualifications Bachelor of Science degree At least 8 years of regulatory affairs experience in the medical device industry Experience leading multiple successful 510(k) clearances and international regulatory registrations Strong understanding of ISO 13485, FDA regulations, and EU MDR Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis