Dentsply Sirona Brasil
Join to apply for the
Regulatory Affairs Manager
role at
Dentsply Sirona Brasil Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies. The company develops, manufactures, and markets dental and oral health products and other regulated devices. The global headquarters are in Charlotte, NC, USA. The company’s shares are listed on NASDAQ under the symbol XRAY. This position can be a hybrid working arrangement, for someone near one of the following locations: Milford, DE; Sarasota, FL; Charlotte, NC; Johnson City, TN; Waltham, MA; or York, PA. Job Summary
The primary responsibility is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other regulated products. It manages and submits 510(k)s for products and manages communications with the FDA including pre-submissions. The individual will mentor and provide guidance to direct reports and cross-functional product development teams on US and EU regulatory requirements. The role works with business partners for registrations in their respective countries to ensure global compliance and acts as an internal champion for initiatives aimed at improving business systems and compliance. Key Responsibilities
Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally. Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking. Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre-submissions, FDA 510(k) submissions, and EU technical file submissions. Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements to ensure compliance. Coordinates regulatory activities with internal teams and external regulatory agencies. Reviews and approves product labeling and claims for the US and EU markets. Stays current with regulatory requirements and updates policies and procedures accordingly. Fosters professional interactions with internal and external stakeholders to enhance business relationships. Manages day-to-day activities for less senior Regulatory Affairs professionals, including mentoring, coaching, performance reviews, developmental plans, and succession planning. Complies with company and departmental policies and administrative requirements; performs other duties as assigned. Education
Bachelor's degree in a relevant field (life sciences, regulatory affairs, or related discipline). Regulatory Certification (e.g., RAC) or Master’s degree in a scientific discipline is a plus. Years and Type of Experience
5+ years of experience in regulatory affairs, preferably in the medical device industry. Experience leading regulatory submissions and managing regulatory projects. Deep knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR). Experience with software as a medical device, AI, and/or medical devices containing software is a plus. Required Computer / Software Skills
Proficiency with Microsoft Office Suite. Proficiency with regulatory software. Key Skills and Capabilities
Strong leadership, project management, and organizational skills with attention to detail. Strong written and verbal communication skills. Technical writing experience and proven track record with FDA and EU regulatory submissions. Excellent interpersonal skills; ability to work effectively in a team and independently. Knowledge of regulatory affairs principles and practices; ability to critically review detailed scientific information. Willingness to learn and adapt to new processes and technologies. Leadership experience within medical device organizations. Leadership Behaviors
Articulates and promotes the company’s vision and direction. Advocates on behalf of the customer; values excellence and high performance. Promotes innovation and continual improvement; ensures compliance with company standards and ethics. Strong results orientation and analytical skills; clear communication across multiple levels and teams. Resolves conflicts and fosters a positive working environment. EEO Statement: Dentsply Sirona is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. For disability accommodation requests, email careers@dentsplysirona.com with “Accommodation Request” in the subject. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Regulatory Affairs Manager
role at
Dentsply Sirona Brasil Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies. The company develops, manufactures, and markets dental and oral health products and other regulated devices. The global headquarters are in Charlotte, NC, USA. The company’s shares are listed on NASDAQ under the symbol XRAY. This position can be a hybrid working arrangement, for someone near one of the following locations: Milford, DE; Sarasota, FL; Charlotte, NC; Johnson City, TN; Waltham, MA; or York, PA. Job Summary
The primary responsibility is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other regulated products. It manages and submits 510(k)s for products and manages communications with the FDA including pre-submissions. The individual will mentor and provide guidance to direct reports and cross-functional product development teams on US and EU regulatory requirements. The role works with business partners for registrations in their respective countries to ensure global compliance and acts as an internal champion for initiatives aimed at improving business systems and compliance. Key Responsibilities
Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally. Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking. Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre-submissions, FDA 510(k) submissions, and EU technical file submissions. Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements to ensure compliance. Coordinates regulatory activities with internal teams and external regulatory agencies. Reviews and approves product labeling and claims for the US and EU markets. Stays current with regulatory requirements and updates policies and procedures accordingly. Fosters professional interactions with internal and external stakeholders to enhance business relationships. Manages day-to-day activities for less senior Regulatory Affairs professionals, including mentoring, coaching, performance reviews, developmental plans, and succession planning. Complies with company and departmental policies and administrative requirements; performs other duties as assigned. Education
Bachelor's degree in a relevant field (life sciences, regulatory affairs, or related discipline). Regulatory Certification (e.g., RAC) or Master’s degree in a scientific discipline is a plus. Years and Type of Experience
5+ years of experience in regulatory affairs, preferably in the medical device industry. Experience leading regulatory submissions and managing regulatory projects. Deep knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR). Experience with software as a medical device, AI, and/or medical devices containing software is a plus. Required Computer / Software Skills
Proficiency with Microsoft Office Suite. Proficiency with regulatory software. Key Skills and Capabilities
Strong leadership, project management, and organizational skills with attention to detail. Strong written and verbal communication skills. Technical writing experience and proven track record with FDA and EU regulatory submissions. Excellent interpersonal skills; ability to work effectively in a team and independently. Knowledge of regulatory affairs principles and practices; ability to critically review detailed scientific information. Willingness to learn and adapt to new processes and technologies. Leadership experience within medical device organizations. Leadership Behaviors
Articulates and promotes the company’s vision and direction. Advocates on behalf of the customer; values excellence and high performance. Promotes innovation and continual improvement; ensures compliance with company standards and ethics. Strong results orientation and analytical skills; clear communication across multiple levels and teams. Resolves conflicts and fosters a positive working environment. EEO Statement: Dentsply Sirona is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. For disability accommodation requests, email careers@dentsplysirona.com with “Accommodation Request” in the subject. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr