Dentsply Sirona · 3 days ago
Regulatory Affairs Manager
Charlotte, NC
Full-time
Hybrid
Senior Level
5+ years expDentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, dedicated to improving dental care. The Regulatory Affairs Manager will oversee the day-to-day functions of the Essential Dental Solutions team, develop regulatory strategies, manage submissions, and provide guidance on regulatory requirements.
DentalEducationHealth CareManufacturingMedical Device
Responsibilities
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 labelling 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 but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning
Complies with company and departmental policies and administrative requirements
Performs other duties as assigned or as needed
Qualification
Required
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 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 including 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
Preferred
Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus
Experience with software as a medical device, AI and/or medical devices containing software is a plus
Company
Dentsply Sirona
Dentsply Sirona is a manufacturer of dental products and technologies.
10001+ employees
H1B Sponsorship
Dentsply Sirona has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (28)
2024 (14)
2023 (7)
2022 (14)
2021 (9)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$550M2025-06-05Post Ipo Debt· $550M
1987-08-21IPO
Leadership Team
Daniel Scavilla
President and Chief Executive Officer
Matthew Garth
Chief Financial Officer
Recent News
2025-11-25
Company data provided by crunchbase