Dentsply Sirona
Overview
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies. The company develops, manufactures, and markets comprehensive solutions for dental and oral health, including other consumable medical devices, under a portfolio of world-class brands. Dentsply Sirona’s global headquarters is in Charlotte, North Carolina, USA. The company’s shares are listed on NASDAQ under the symbol XRAY. 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 to bring 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 part of a team that is shaping an industry, we’re looking for the best to join us. This position can be a hybrid working arrangement, for someone near Milford, DE; Sarasota, FL; Charlotte, NC; Johnson City, TN; Waltham, MA; or York, PA. Job Summary
The primary job 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. This role manages and submits 510(k)s 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. This role collaborates with business partners for registrations in their respective countries to ensure global compliance and acts as an internal champion for initiatives to improve 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 US and EU markets. Stays current with regulatory requirements and updates affected policies and procedures. Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing 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 or as needed. Education
Bachelor’s degree in a relevant field, such as 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 with leading regulatory submissions and managing regulatory projects. In-depth 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 Required Skills, Knowledge, and Capabilities
Strong leadership, project management, and organizational skills with attention to detail. Strong written and verbal communication skills. Prior technical writing experience and proven track record with FDA and EU regulatory submissions. Excellent interpersonal skills. Ability to work effectively in a team environment and independently. Knowledge of regulatory affairs principles and practices. Ability to critically review detailed scientific information and ensure arguments are clear and supported. Willingness to learn and adapt to new processes and technologies. Leadership experience within medical device organizations. Key Leadership Behaviors
Actively articulates and promotes Dentsply Sirona’s vision and direction. Advocates on behalf of the customer. Values-driven with an insistence on excellence. Promotes high performance, innovation, and continual improvement. Consistently meets Company standards, ethics, and compliance requirements. Strong results orientation and analytical skills. Clear and effective communication with key stakeholders across multiple levels and cross-functional areas. Resolves conflicts and fosters a positive working environment. Equal Opportunity
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com. Please include “Accommodation Request” in the subject line.
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Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies. The company develops, manufactures, and markets comprehensive solutions for dental and oral health, including other consumable medical devices, under a portfolio of world-class brands. Dentsply Sirona’s global headquarters is in Charlotte, North Carolina, USA. The company’s shares are listed on NASDAQ under the symbol XRAY. 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 to bring 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 part of a team that is shaping an industry, we’re looking for the best to join us. This position can be a hybrid working arrangement, for someone near Milford, DE; Sarasota, FL; Charlotte, NC; Johnson City, TN; Waltham, MA; or York, PA. Job Summary
The primary job 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. This role manages and submits 510(k)s 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. This role collaborates with business partners for registrations in their respective countries to ensure global compliance and acts as an internal champion for initiatives to improve 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 US and EU markets. Stays current with regulatory requirements and updates affected policies and procedures. Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing 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 or as needed. Education
Bachelor’s degree in a relevant field, such as 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 with leading regulatory submissions and managing regulatory projects. In-depth 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 Required Skills, Knowledge, and Capabilities
Strong leadership, project management, and organizational skills with attention to detail. Strong written and verbal communication skills. Prior technical writing experience and proven track record with FDA and EU regulatory submissions. Excellent interpersonal skills. Ability to work effectively in a team environment and independently. Knowledge of regulatory affairs principles and practices. Ability to critically review detailed scientific information and ensure arguments are clear and supported. Willingness to learn and adapt to new processes and technologies. Leadership experience within medical device organizations. Key Leadership Behaviors
Actively articulates and promotes Dentsply Sirona’s vision and direction. Advocates on behalf of the customer. Values-driven with an insistence on excellence. Promotes high performance, innovation, and continual improvement. Consistently meets Company standards, ethics, and compliance requirements. Strong results orientation and analytical skills. Clear and effective communication with key stakeholders across multiple levels and cross-functional areas. Resolves conflicts and fosters a positive working environment. Equal Opportunity
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com. Please include “Accommodation Request” in the subject line.
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