Senior Regulatory Affairs Specialist

Senior Regulatory Specialist 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 New Product Development and Sustaining activities for the US, Canada and EU markets, and 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, 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 labeling 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 communication channels 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 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) Computer / Software Skills Proficiency with Microsoft Office Suite Proficiency with regulatory software Key Skills, Knowledge, and Capabilities Strong attention to detail and organizational skills Excellent communication (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 medical device organizations Prior technical writing experience and a 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. #J-18808-Ljbffr