Regulatory Affairs Manager

The Regulatory Affairs Manager (“RAM”) at Sirona will help build a comprehensive, global regulatory system, support teams in executing quality and regulatory guidance, identify and resolve regulatory-related issues, and drive continuous improvement. This individual will lead the execution of cross-functional regulatory initiatives and serve as a key representative and partner to the VP of Regulatory Affairs and Quality Assurance.

Key Responsibilities:

• Partner with leadership and product managers to establish medical device classifications. Execute related plans to obtain required regulatory clearances or approvals in a timely manner
• Leverage external regulatory firms to design regulatory strategies and lead internal execution
• Determine regulatory requirements for selling and marketing Sirona medical devices globally, including local device classification, registrations, and in-country representation with appropriate partners
• Host audits and inspections conducted by U.S. and global regulatory agencies or standards bodies
• Collaborate cross-functionally to ensure regulatory requirements, concepts, processes, and objectives are clearly understood by all stakeholders
• Manage execution of regulatory affairs plans, including defining progress metrics and implementing escalation processes as needed
• Define and execute required regulatory certifications and MDSAP plans
• Host internal audits and regulatory inspections in partnership with the VP of RAQA
• Work closely with the engineering organization to establish, track, and continuously improve regulatory metrics
• Develop deeper regulatory and quality expertise through hands-on experience and mentorship
• Represent the VP of RAQA as needed, exercising sound judgment and decision-making (e.g., managing high-volume inquiries or operational decisions)
• Maintain a global regulatory watch and advise the business accordingly

Key Requirements:

• 7+ years of medical device regulatory experience, preferably in software or technology-driven environments
• Working knowledge of FDA medical device regulations (Class I and/or II), EU MDR, and global regulatory standards, including ISO 13485
• Strong organizational and communication skills, with the ability to produce clear, concise, and well-maintained documentation
• Experience conducting internal audits or supporting audit activities
• Experience hosting audits and regulatory inspections
• Ability to write, edit, and improve quality and regulatory procedures covering the full product lifecycle from pre-market through post-market
• Ability to create and deliver training materials for new or updated procedures
• Demonstrated ability to quickly learn and implement new quality management and regulatory standards
• A proactive self-starter with a positive, growth-oriented mindset

Benefits

• Stock Options
• Medical, dental, vision insurance
• Life insurance
• Maternity and Paternity Leave
• Flexible time off
• 401K matching
• MacBook Pro 
• Sponsorship for conferences, continuing education, etc.

The annual US base salary range for this full-time position is $130,000 - $160,000 + equity + benefits. Pay scale is flexible depending on experience. Within the range, individual pay is determined by work location and additional factors, including job-related skills, competencies, experience, relevant education and training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.