Regulatory Affairs Specialist

Dentsply Sirona, Inc

1d • Hybrid

About The Position

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, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. 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 hyrbid working arrangement for someone that is near one of the following locations: Sarasota, FL, Charlotte, NC, or York, PA Job Scope: Contributing member of cross-functional teams in support of regulatory market access activities for US, Canada, EU, and other countries.

Requirements

• 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

Nice To Haves

• Prior technical writing experience and proven track record with FDA and EU regulatory submissions preferred

Responsibilities

• Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissionsand 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees