Dentsply Sirona · 2 weeks ago
Regulatory Affairs Specialist
Sarasota, FL
Full-time
Hybrid
Entry, Mid Level
1+ years expDentsply Sirona is the world’s largest manufacturer of professional dental products and technologies. The Regulatory Affairs Specialist will contribute to cross-functional teams supporting regulatory market access activities and will be responsible for preparing and submitting regulatory submissions for medical devices.
DentalEducationHealth CareManufacturingMedical Device
Responsibilities
Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking
Maintains regulatory files and databases to ensure compliance with regulatory requirements
Reviews and interprets regulatory requirements and guidance documents to ensure compliance
Coordinates regulatory activities with internal teams and external regulatory agencies
Supports regulatory audits and inspections as SME for questions related to market access
Stays current with regulatory requirements and updates affecting medical devices
Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships
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
1-5 years of experience in regulatory affairs, preferably in the medical device industry
Experience with regulatory submissions and documentation, including 510(k) submissions and CE marking
Knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, EU MDR)
Proficiency with Microsoft Office Suite
Proficiency with Regulatory software
Strong attention to detail and organizational skills
Excellent communication (both written and verbal) and interpersonal skills
Ability to work effectively in a team environment
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
Regulatory registration experience within med device organizations
Preferred
Prior technical writing experience and proven track record with FDA and EU regulatory submissions
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
GlobeNewswire
2026-01-16
2026-01-16
Company data provided by crunchbase