Dentsply Sirona
Overview
Join to apply for the
Regulatory Affairs Manager
role at
Dentsply Sirona . 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. The company 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. The 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. 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 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. The role manages and submits 510(k)s and manages communications with 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 works closely 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 files 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.
Reviews and approves product labelling and claims for the 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 a related discipline.
Regulatory Certification (e.g., RAC from the Regulatory Affairs Professionals Society) 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 Skills
Proficiency with Microsoft Office Suite and Regulatory software.
Key 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 and 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
Actively articulates and promotes Dentsply Sirona’s vision and direction.
Advocates on behalf of the customer; values-driven with a focus on excellence.
Promotes high performance, innovation, and continual improvement.
Resolves conflicts and fosters a positive working environment; strong results orientation and analytical skills.
Clear and effective communication with stakeholders across levels, geographies, and functions.
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. If assistance is needed with completing the online application due to a disability, please request accommodations by emailing careers@dentsplysirona.com and include “Accommodation Request” in the subject.
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Join to apply for the
Regulatory Affairs Manager
role at
Dentsply Sirona . 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. The company 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. The 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. 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 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. The role manages and submits 510(k)s and manages communications with 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 works closely 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 files 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.
Reviews and approves product labelling and claims for the 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 a related discipline.
Regulatory Certification (e.g., RAC from the Regulatory Affairs Professionals Society) 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 Skills
Proficiency with Microsoft Office Suite and Regulatory software.
Key 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 and 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
Actively articulates and promotes Dentsply Sirona’s vision and direction.
Advocates on behalf of the customer; values-driven with a focus on excellence.
Promotes high performance, innovation, and continual improvement.
Resolves conflicts and fosters a positive working environment; strong results orientation and analytical skills.
Clear and effective communication with stakeholders across levels, geographies, and functions.
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. If assistance is needed with completing the online application due to a disability, please request accommodations by emailing careers@dentsplysirona.com and include “Accommodation Request” in the subject.
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