Regulatory Affairs Manager

Responsibilities Oversee the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. Develop regulatory strategies for existing, new, and modified medical devices and other regulated products. Manage and submit 510(k)s for the products and communicate with FDA, including pre-submissions. Mentor and provide guidance to direct reports and cross-functional product development teams on US and EU regulatory requirements. Work closely with business partners for registrations in their respective countries to ensure global compliance and act as internal champion for business system and compliance initiatives. Develop and implement regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally. Lead and manage regulatory submissions, including 510(k) submissions, and technical files for CE marking. Manage communications with FDA and EU notified bodies on behalf of the company for FDA pre-submissions, FDA 510(k) submissions, and EU technical file submissions. Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle. Review and interpret regulatory requirements and guidance documents to ensure compliance. Coordinate regulatory activities with internal teams and external regulatory agencies. Review and approve product labeling and claims for the US and EU markets. Stay current with regulatory requirements and update affected policies and procedures. Foster professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships. Manage day-to-day activities for less senior Regulatory Affairs professionals, including mentoring, coaching, performance reviews, developmental plans, and succession planning. Comply with company and departmental policies and administrative requirements. Perform other duties as assigned or needed. Actively articulate and promote Dentsply Sirona’s vision and direction. Advocate on behalf of the customer. Value-driven with an insistence on excellence. Promote high performance, innovation, and continual improvement. Consistently meet company standards, ethics, and compliance requirements. Resolve conflicts and foster a positive working environment. Bachelor’s degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline. Requirements 5 (+) years of experience in regulatory affairs, preferably in the medical device industry. Experience with leading regulatory submissions and managing regulatory projects. In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR). Proficiency with Microsoft Office Suite. Proficiency with regulatory software. Strong leadership, project management, and organizational skills with attention to detail. Strong written and verbal communication skills. Prior technical writing experience and proven track record with FDA and EU regulatory submissions. Excellent interpersonal skills. Ability to work effectively in a team environment and independently. Knowledge of regulatory affairs principles and practices. Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported. Willingness to learn and adapt to new processes and technologies. Leadership experience within medical device organizations. Strong results orientation and analytical skills. Clear and effective communication with key stakeholders across multiple levels, socio-geographic areas, and functional expertise. Seniority Level Mid-Senior level Employment Type Contract Job Function Legal Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO