Senior Manager, Regulatory Affairs - Remote

Date: Jul 10, 2024

Location: USA Home Office, --, US, NA

Company: Dentsply Sirona, Inc

 

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, Regulatory Affairs CAD/AI will possess and apply their knowledge, skills/abilities, and understanding of regulatory and legal frameworks, regulatory requirements, and processes and procedures in support of the Dentsply Sirona Connected Technology Solutions (CTS) portfolio. This includes but is not limited to Computer Aided Design Systems, Artificial Intelligence / Machine Learning (AI/ML) applications, SaMD, Clinical Decision Support Software, and cloud / other connected devices and platforms.

 

This role develops regulatory strategies for existing, new, and modified medical devices and other products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to cross-functional product development teams on US and EU regulatory requirements.

 

This role works closely with regulatory partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.

 

This position is Remote in the USA. Preference to Eastern and Central states to align with global partners.

 

Key Responsibilities:

  • Develops and executes regulatory strategies to obtain and maintain regulatory approvals for medical devices
  • Manage US and EU regulatory assessments for product changes, manufacturing site changes or legal manufacturer changes and issue comprehensive strategies to ensure business continuity
  • Oversees approval of labeling claims for the US and EU
  • Oversees regulatory submissions, including 510(k) submissions, and technical files for CE marking
  • Issues / updates Standard Operating Procedures to harmonize regulatory activities across the Global business Units
  • 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
  • Manages regulatory audits and inspections
  • 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
  • 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
  • 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, ISO 14971, IEC 62304, IEC 62366)
  • Experience with SaMD, Agile development, computer aided design, and/or artificial intelligence
  • Previous management or leadership experience

 

Required Computer / Software Skills:

  • Proficiency with Microsoft Office Suite
  • Proficiency with Regulatory software

 

Key Required Skills, Knowledge, and Capabilities:

  • Strong leadership, project management, organizational skills, with attention to detail
  • Ability to work effectively in a team environment
  • Knowledge of regulatory affairs principles and practices
  • Willingness to learn and adapt to new processes and technologies
  • Leadership experience within med device organizations
  • Strong written and verbal communication
  • Exceptional interpersonal skills

 

 

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 be sure to include “Accommodation Request” in the subject.