Regulatory Affairs Specialist

Role Overview

• 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

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

Benefits

• Equal Opportunity Employer: All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.
• Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to accommodationrequest@dentsplysirona.com .