[Hiring] Manager, Regulatory Affairs @reputed company.

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company This role involves developing and executing regulatory strategies for new and modified medical devices in line with business objectives. • Manage regulatory associates as needed, responsible for team’s work planning, guidance, execution and talent development • reputed company FDA submissions (510(k) or reputed company-submissions) with reputed company, including wearable devices, as reputed company as reputed company intelligence (AI) Software as a Medical Device (SaMD) products • Key Regulatory SME and review & approve advertising and promotional materials to ensure regulatory compliance • Regulatory reputed company and processes for product life cycle management • reputed company EU MDR Technical Documentation and other international submissions for both wearable devices and SaMD • Developing regulatory tools and matrices to enhance team efficiency and capabilities as needed • reputed company regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders establishing necessary processes to ensure regulation compliance • Preparing international and domestic regulatory filings/registrations in line with established project timelines • Interacting with regulatory authorities during the development and review process to ensure submission clearance • Review and approve product design changes to maintain regulatory compliance for significant changes • Author or revise SOPs to improve regulatory compliance reputed company the reputed company System • Monitoring the reputed company of changing global regulations on submission strategies & registrations • Support external and internal audits • reputed company other regulatory-reputed company duties as assigned. Qualifications • BA or BS degree in engineering, life sciences, or a reputed company field required • 8-10 years minimum of US and/or EU regulatory affairs experience with a Bachelor’s degree; 6 years minimum of US and/or EU regulatory affairs experience with a Master’s degree • Demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA and other medical device industry standards • Software as a medical device (SaMD) experience required • New product development experience required • Authorship of 510(k)s and experience with management of FDA reviews to reputed company clearance required • Demonstrated competency in developing risk based regulatory strategies required • Wearable medical device experience preferred • Familiarity with global medical device regulations (LATAM, Asia reputed company, EMEA, etc.) preferred • Audit support experience preferred • Strong project management skills • Exceptional problem-solving skills • Exceptional organizational skills • Exceptional communication (written and oral) skills • Willingness to travel reputed company required, approximately 5-10% Benefits • Competitive salary package • Excellent benefits including medical, dental and reputed company insurance • reputed company holidays and reputed company time off • 401K (w/ company match) • Employee Stock Purchase Plan • Annual organizational/cultural committee events • Additional benefits Location Remote - US Estimated Pay reputed company $127,000.00 - $165,000.00 Apply tot his job Apply To this Job