Regulatory Affairs Specialist

Dentsply Sirona, Inc • Madison, WI

1d • Hybrid

About The Position

We are seeking an experienced and highly motivated Regulatory Affairs Specialist who will be a contributing member of a cross-functional team in support of regulatory market access activities for US, Canada, EU, and other countries. This position can be located in one of the following DS facilities: Sarasota, FL; Charlotte, NC; Johnson City, TN; Milford, DE; York, PA; Waltham, MA.

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) 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level