Regulatory Affairs Manager

Regulatory Affairs Manager – Katalyst CRO Join to apply for the Regulatory Affairs Manager role at Katalyst CRO. Responsibilities Overseeing the day‑to‑day functions of the Dentsply Sirona Essential Dental Solutions team. Developing regulatory strategies for existing, new, and modified medical devices and other regulated products. Managing and submitting 510(k) submissions and communications with FDA, including pre‑submission activities. Mentoring and guiding direct reports and cross‑functional product development teams on US and EU regulatory requirements. Working closely with business partners for registrations in their respective countries to ensure global compliance and acting as an internal champion for initiatives aimed at improving business systems and compliance. Developing and implementing regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products worldwide. Leading and managing regulatory submissions, including 510(k) submissions and technical files for CE marking. Managing 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. Providing regulatory guidance and support to cross‑functional teams throughout the product lifecycle. Reviewing and interpreting regulatory requirements and guidance documents to ensure compliance. Coordinating regulatory activities with internal teams and external regulatory agencies. Reviewing and approving product labeling and claims for the US and EU markets. Staying current with regulatory requirements and updating affected policies and procedures. Fostering professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships. Managing day‑to‑day activities for less senior Regulatory Affairs professionals, including mentoring, coaching, performance reviews, developmental plans, and succession planning. Complying with company and departmental policies and administrative requirements. Performing other duties as assigned or as needed. Actively articulating and promoting Dentsply Sirona's vision and direction. Advocating on behalf of the customer. Maintaining a values‑driven focus with an insistence on excellence. Promoting high performance, innovation, and continual improvement. Consistently meeting company standards, ethics, and compliance requirements. Resolving conflicts and fostering a positive working environment. Holding a 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 leading regulatory submissions and managing regulatory projects. In‑depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR). Required computer and software skills: proficiency with Microsoft Office Suite and 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 both team and independent settings. 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 Industries Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO