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

About the position As the Director, Regulatory Affairs - Regulatory Operations and reputed company America 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 active 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 the 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 direct 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 a team of regulatory professionals, fostering professional growth and promoting a high-performance culture. , • Provide strategic leadership and guidance to RA team members embedded in project core teams. , • Work closely with R&D, Quality Assurance, Marketing, and Manufacturing teams to align 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. , • Act as the primary liaison 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 matrix 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 Professional 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 options , • 401k plan with company match , • Company paid life/ad&d insurance , • Additional supplemental life/ad&d coverage available , • Company paid Short/Long-Term Disability coverage (STD/LTD) , • STD LTD Buy-reputed company available , • Accident/Hospital Indemnity coverage , • Legal/ID Theft Assistance , • PTO (or sick and vacation time), floating Diversity Day, & paid holidays , • Paid parental bonding leave , • Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more) , • Robust Internal Career Growth opportunities , • Tuition reimbursement , • Hearing aid discount for employees and family , • Internal social recognition platform , • D&I focused: D&I council and employee resource groups Apply Job!