Essential Duties and Responsibilities:

• Prepares regulatory strategies for new devices, and product claim expansion.
• Ensures technical accuracy, regulatory compliance, and timely submission for all new product applications, product design changes, registrations and re- registrations,
• Prepares and submits product registration files (US and OUS) to obtain or maintain registration approval and import licenses per local Regulatory requirements for CE Marketed/FDA cleared devices in the countries where the company’s plans to distribute products. (Europe, Middle East, APAC, etc.)
• Is the primary contact for the US FDA.
• Authors 510(k)s or other Regulatory submissions and maintains product Technical Files
• Reviews complaints for possible trends and Adverse Events/MDRs and leads ad hoc complaint committees in making regulatory reporting decisions. Prepares and submits Adverse Event/MDR reports to regulatory agencies in a timely manner to meet regulatory reporting deadlines.
• Supports Global expansion in all Regulatory capacities
• Clearly communicates strategies to the Senior Leadership Team (SLT) and core operational teams.
• Expands regulatory knowledge of all business-related geographies, Distributors, local Trade Associations, and other Sources of Regulatory Intelligence.
• Develops Regulatory Affairs processes as needed and/or optimization of existing processes to strengthen the RA department.
• Provide interpretive analyses to the SLT of complex regulatory guidance documents, regulations, or directives that impact the company’s products and operations. Advise personnel in other departments regarding their applicability and impact.
• Maintains proficiency in broad regulatory requirements. Develops strategies on effective interactions with government agencies and agency personnel.
• Other duties as assigned.

Education and/or Experience:

• Bachelor’s degree in a scientific or technical field or equivalent experience.Master’s degree or PhD strongly preferred.
• 10+ years of Regulatory experience in the Med/Device Industry
• 5+ years of demonstrated experience in multiple types of international regulatory submissions (Europe, South Korea, Kingdom of Saudi Arabia, Australia, among others)
• Must have working knowledge of FDA, ISO 13485, EU MDR, and other applicable regional regulations for handling regulatory compliance, complaint reporting and implementing associated corrective actions
• Ability to make decisions in a timely manner, sometimes with incomplete information and under tight deadlines
• Proven analytical capabilities
• Excellent communication, organizational, and project management skills
• Successful experience working with cross functional teams across multiple work locations (third parties)
• Work cooperatively in a team environment