**Role & seniority: ** Regulatory Affairs (Medical Devices) Coordinator / RA–QA interface role (local Philippines coordination; reports into RA/QA leadership per scope)

**Stack/tools: ** Document management and regulatory tracking; QMS processes and device compliance workflows (tools not specified in text). Working with PFDA/OMB/NTC documentation and internal RA/QA systems (unspecified).

**Top 3 responsibilities: **

Product registration & licensing: Manage registrations, renewals, change notifications; maintain all licenses/LTOs; coordinate with PFDA, OMB, NTC, and other authorities.
Quality management: Implement/maintain QMS aligned to PFDA and local standards; oversee device incident reporting, complaints, CAPA, risk assessment, and non-conformance processes.
Cross-functional/regional/global coordination: Act as the internal link between local, regional, and global teams; coordinate submissions, compliance actions, and manufacturer liaison.
Must-have skills:
- Medical device regulatory compliance knowledge (PFDA, OMB, NTC and related requirements)
- QMS understanding and ability to run complaint/incident, CAPA, risk and non-conformance workflows
- Strong stakeholder management and communication with regulators and internal teams; ability to meet regulatory timelines
Nice-to-haves:
- Experience coordinating device licensing transfers/changes and monitoring regulatory updates for proactive

Full Description

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.

Role Purpose & Scope Coordinate regulatory and quality processes for Medical Devices in the Philippines, ensuring compliance with PFDA, OMB (Optical Media Board), NTC (National Telecommunication Commission), and other relevant authorities. Ensure timely product registrations, maintenance of all licenses (including LTOs), and alignment with business strategy. Serve as the internal link between local, regional, and global teams.

Key Accountabilities

Product Registration & Licensing

Manage product registration, license renewals, change notifications, and communications with PFDA, OMB, NTC, and other relevant authorities. Ensure all licenses, including LTOs, comply fully with requirements of each authority. Advise on regulatory pathways of all related authorities and maintain manufacturer liaison.

Quality Management:

Implement and maintain QMS in line with PFDA and other applicable local standards. Monitor regulatory changes and maintain device incident reporting, complaint handling, CAPAs, risk assessment, and non-conformance processes.

Collaboration / Interfaces

Internal: RA Manager, Sales, Marketing, Supply Chain, Customer service Regional and GBU RA Teams

External: Regulatory Authorities, Manufacturers, Trade Associations, Key Opinion Leaders

Decision Rights / Authority

Approve local regulatory submissions within defined timelines and company guidelines. Recommend strategies for registration, license transfers, and QMS improvements. Escalate regulatory risks and compliance issues to the RA & QA Manager. Collaborate with cross-functional teams to ensure alignment on regulatory actions.

Success Indicators

All licenses, including LTOs, fully compliant with PFDA, OMB, NTC, and other relevant authority requirements. Timely submission and approval of product registrations and renewals. Proactive identification and implementation of regulatory changes to ensure ongoing compliance. Zero major audit or compliance findings from authority inspections. Effective communication and collaboration with authorities, manufacturers, and internal teams.

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.

Regulatory Affairs and Quality Assurance Specialist, Philippines

Full Description

Working at Dentsply Sirona you are able to

Product Registration & Licensing