Regulatory Affairs Manager

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Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies. The company develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices. The global headquarters is located in Charlotte, NC, USA.

Location:

This position can be a hybrid arrangement for candidates near Milford, DE;
Sarasota, FL;
Charlotte, NC;
Johnson City, TN;
Waltham, MA; or York, PA.

The primary responsibilities are overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other regulated products. The role manages and submits 510(k) filings and communicates with the FDA, including pre-submissions. It also includes mentoring and guiding direct reports and cross-functional product development teams on US and EU regulatory requirements, and collaborating with business partners for global registrations.

• Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
• Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
• Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre-submissions, FDA 510(k) submissions and EU technical files submissions.
• Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
• Coordinates regulatory activities with internal teams and external regulatory agencies.
• Reviews and approves product labeling and claims for the US and EU markets.
• Stays current with regulatory requirements and updates affected policies and procedures.
• Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
• Manages day-to-day activities for less senior Regulatory Affairs professionals, including mentoring, coaching, performance reviews, development plans, and succession planning.
• Complies with company and departmental policies and administrative requirements.
• Performs other duties as assigned or as needed.

• Bachelor’s degree in a relevant field, such as life sciences or regulatory affairs.
• Regulatory Certification (e.g., RAC) or Master’s degree in a scientific discipline is a plus.

• 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).
• Experience with software as a medical device, AI, and/or medical devices containing software is a plus.

• 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.
• Technical writing with proven FDA and EU regulatory submissions experience.
• Excellent interpersonal skills and ability to work in a team or independently.
• Knowledge of regulatory affairs principles and practices.
• Ability to critically review scientific information and ensure arguments are clearly presented with adequately supported conclusions.
• Willingness to learn and adapt to new processes and technologies.
• Leadership experience within medical device organizations.

• Articulates and promotes Dentsply Sirona’s vision and direction.
• Advocates on behalf of the customer.
• Values excellence and promotes high performance, innovation, and continual improvement.
• Ensures compliance with company standards, ethics, and regulatory requirements.
• Strong results orientation and analytical skills; clear and effective cross-functional communication.
• Resolves conflicts and fosters a positive working environment.

Equal Opportunity Dentsply Sirona is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. If you need assistance with completing the online application due to a disability, please send an accommodation request to , including “Accommodation Request” in the subject line.