Senior Regulatory Affairs Specialist

Senior Regulatory 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. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.

Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us. Working at Dentsply Sirona you are able to: Develop faster - with our commitment to the best professional development. Perform better - as part of a high-performance, empowering culture. Shape an industry - with a market leader that continues to drive innovation. Make a difference -by helping improve oral health worldwide.

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.

Job Summary

The Senior Regulatory Specialist is a contributing member of cross-functional teams in support of regulatory market access activities for US, Canada, EU, and other countries. May support NPD and Sustaining activities for the US, Canada and EU markets. Also supports additional international registrations.

Key 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

Education

Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline

Years and Type of Experience

5(+) years of experience in regulatory affairs, preferably in the medical device industry 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)

Required Computer / Software Skills

Proficiency with Microsoft Office Suite Proficiency with Regulatory software

Key Required 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.

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.