Regulatory Affairs Manager

Regulatory Affairs Manager – Katalyst CRO

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• 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.

• 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.

Mid‑Senior level

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Legal

Pharmaceutical Manufacturing