Dentsply Sirona

Requistion ID: 80589

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.

Position Summary

Supports regulatory affairs activities for medical device licenses in Vietnam.Manages requests for and strategically plan work related to registration activities in Vietnam. Manages projects and/or regulatory affairs for the assigned Location(s)/Region(s).

Key Responsibilities

• Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices
• Leads and manages regulatory submissions
• Manage communications with authorities on behalf of the company for market access related submissions
• 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
• 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
  
  

Typical Background

Education

• Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
  
  

Language

• Fluent in written, reading, spoken and listening English.
• Fluent in written, reading and spoken Vietnamese
  
  

Years And Type Of Experience

• 5(+) years of experience in Vietnam regulatory affairs, preferably in the medical device industry
• Knowledge of Vietnamese Regulations and classifications
• Knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, 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
  
  

Key Required Skills, Knowledge, And Capabilities

• Strong leadership, project management, and organizational skills, including attention to detail
• Excellent communication (both written and verbal) and interpersonal skills
• Ability to work effectively in a team environment, as well as independently
• Willingness to learn and adapt to new processes and technologies
  
  

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, which span across multiple levels, socio-geographic areas, and functional expertise
• Resolves conflicts and fosters a positive working environment
• Be a change leader
  
  

DentsplySirona 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 DentsplySirona.

If you need assistance with completing the online application due to a disability, please send an accommodation request to [email protected]. Please be sure to include “Accommodation Request” in the subject.