Senior Manager, Regulatory Affairs

 

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.

 

Bringing out the best in people

 

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.  

 

 

Job Summary:

 

The Senior Manager of Regulatory Affairs supports regulatory affairs activities for US FDA 510k submissions, Health Canada medical device licenses, and EU Technical Files. Manages requests for and strategically plan work related to global international registration activities Manages projects and/or regulatory affairs team members in support of NPD and sustaining projects for the assigned Business Unit(s)/Location(s)/Region(s).  Leads and manages a team of regulatory affairs professionals, providing guidance and mentoring.

 

Key Responsibilities:

• Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices
• Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking
• Manage communications with FDA, Health Canada and EU notified bodies on behalf of the company for market access related submissions
• Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle 
• Reviews and interprets regulatory requirements and guidance documents to ensure compliance
• Coordinates regulatory activities with internal teams and external regulatory agencies
• Review and approve product labelling and claims for the US, Canada and EU
• 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
• Leads and manages a team of regulatory affairs professionals, providing guidance and mentoring. Manage day to day activities for less senior Regulatory Affairs professionals.
• 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
• Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Advanced degree preferred

 

Years and Type of Experience:

• 8(+) years of experience in regulatory affairs, preferably in the medical device industry
• Experience with leading regulatory submissions and managing regulatory projects
• In-depth knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, EU MDR)
• Previous management or leadership experience
• Experience with software as a medical device, AI and/or medical dev