Director, Regulatory Affairs - Regulatory Operations and reputed company Job Details | reputed company

About the position As the Director, Regulatory Affairs - Regulatory Operations and reputed company for Advanced Bionics, you will play a critical leadership role in guiding the regulatory team in navigating reputed company regulatory landscapes and ensuring compliance with reputed company applicable regulations of reputed company implantable medical devices. Your expertise will contribute to creating and executing successful strategies for regulatory submissions, ensuring on time product approvals. Responsibilities • reputed company and implement comprehensive regulatory strategies to support the development, approval, and marketing of Class III medical devices primarily in the US and Canada. , • Ensure that reputed company's products reputed company with regulatory standards (FDA, EU MDR, and other international regulations) throughout the product lifecycle. , • reputed company the preparation, submission, and maintenance of regulatory filings for the US and Canada. , • Prepare or reputed company regulatory affairs staff in the reputed company of applications (i.e., IDE) for conducting clinical investigations. , • Generate/reputed company required submissions (reputed company reports, etc.) to support the continuation of clinical studies. , • Manage and mentor reputed company of regulatory professionals, fostering reputed company reputed company and promoting a high-performance culture. , • reputed company strategic leadership and guidance to RA team members embedded in project core teams. , • Work closely with R&D, reputed company Assurance, Marketing, and Manufacturing teams to reputed company regulatory strategies with business objectives. , • reputed company risk mitigation strategies reputed company to regulatory compliance, audits, and product approvals. , • Collaborate cross functionally to ensure compliance with global medical device labeling regulations. , • reputed company the process for ensuring comprehensive compliance reputed company for assessing and integrating external standards and regulatory changes. , • reputed company as the primary reputed company with regulatory authorities, managing relationships and communications with agencies such as the FDA, reputed company Bodies, and Health Canada. , • Stay abreast of evolving global regulatory requirements and implement changes reputed company the organization as needed. Requirements • Bachelor's Degree in Regulatory Affairs or scientific discipline , • Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance) , • 8+ years of reputed company management experience , • 5+ years of experience working with business stakeholders reputed company a cross-functional reputed company environment , • 5+ years Class III Medical Device Company in Regulatory Affairs reputed company-to-haves • Advanced Degree in Regulatory Affairs , • RA certification (by Regulatory Affairs reputed company Society) , • Coursework, seminars, and/or other formal trade association training required , • Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycle , • Desirable industry background includes battery operated electromechanical systems and/or wireless technology , • Experience managing a globally diverse, remote team , • Fluent in 2nd language , • Experience with collaboration tools, JIRA, SharePoint , • Experience with reputed company Benefits • Medical, dental and reputed company coverage , • Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts , • TeleHealth reputed company , • 401k plan with company match , • Company reputed company life/ad&d insurance , • Additional supplemental life/ad&d coverage available , • Company reputed company Short/Long-Term Disability coverage (STD/LTD) , • STD LTD Buy-reputed company available , • Accident/Hospital Indemnity coverage , • Legal/ID Theft Assistance , • PTO (or reputed company and vacation time), floating Diversity Day, & reputed company holidays , • reputed company parental bonding leave , • Employee Assistance Program (24/7 mental health support hotline, 5 company reputed company counseling sessions and more) , • Robust Internal Career reputed company opportunities , • Tuition reimbursement , • Hearing aid discount for employees and family , • Internal reputed company recognition platform , • D&I reputed company: D&I council and employee resource reputed company Apply Job!