Senior Regulatory Affairs Specialist

About the Position

Senior Regulatory Affairs Specialist

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. We are seeking a Senior Regulatory Affairs Specialist to join our team in Sarasota, FL, ensuring compliance with FDA and EU regulations for medical devices.

Responsibilities

• Assists in development and execution of regulatory strategies to obtain and maintain regulatory approvals for medical devices
• 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
• Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle
• Participates in review of labelling and claims for the US and EU markets
• 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

Requirements

• Education: Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline
• Experience: 5(+) years of experience in regulatory affairs, preferably in the medical device industry
• Skills:
  • Experience with leading regulatory submissions and documentation, including 510(k) submissions and CE marking
  • In-depth knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, EU MDR)
  • Proficiency with Microsoft Office Suite
  • Proficiency with Regulatory software
• Key Skills, Knowledge, and Capabilities:
  • 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
  • Prior technical writing experience and proven track record with FDA and EU regulatory submissions preferred.

We Offer

• Opportunity to work with a market leader that continues to drive innovation
• Commitment to professional development
• High-performance, empowering culture
• Ability to make a difference by helping improve oral health worldwide

About the Company

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Our global headquarters is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Locations

• Sarasota, FL, US
• York, PA, US
• Waltham, MA, US
• Milford, DE, US
• Charlotte, NC, US

Work Arrangement

This position can be a hybrid working arrangement for someone that is near one of the following Dentsply Sirona locations: Sarasota, FL; Charlotte, NC; Milford, DE; or York, PA. Internal applicants that are already working fully remotely can continue to work remotely if selected to fill this position.

Equal Opportunity Employer

Dentsply Sirona is an Equal Opportunity 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.

Contact

For California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes).

For additional details and questions, contact us at [email protected]

**Nearest Major Market: **Sarasota

**Nearest Secondary Market: **Tampa

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