Regulatory Affairs Specialist… at Dentsply Sirona · Location…

Requistion ID: 84251

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century 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 dental care. Dentsply Sirona’s headquarter is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.

SUMMARY OF POSITION:

• Ensure timely registration of new product registration & Maintenance of existing product license
• Compliance with MFDS & Corporate requirements
• Support with internal/external KGMP audit/inspections as company representative.
• Document control: Device Master File, Labelling

DUTIES & RESPONSIBILITIES:

• Account for the assigned new registration & maintenance projects and updates of existing product licenses
• Anticipate regulatory environmental changes and take appropriate actions to cope with the situation
• Ensure all regulatory compliance activities and fulfil responsibilities to secure business continuity, including supporting KGMP certificates, labelling, approval variation, annual reporting, and product renewal, in accordance with country and global company regulatory requirements
• Comply with all legal, regulatory, and ethical business requirements while executing the assigned roles and responsibilities, as defined in the local regulations and Corporate procedures.
• Develop and lead local language labeling & promotional material review.
• Support internal tasks assigned by the line manager.
• Actively participate in industry meetings and MFDS explanatory conferences, share the information from these meetings with the team and other departments
• Have experience with UDI (unique device identifier), UDI database, and in-depth knowledge of MFDS requirements

KNOWLEDGE, SKILLS & EXPERIENCE:

• University/Bachelor’s Degree and Major in science or engineering preferred
• More than 3 years’ experience in regulatory affairs of medical device
• Specialized knowledge of regulatory activities
• Experience with KGMP is favoured

COMPETENCIES:

• Fluent in English
• Ability to manage multiple and varied tasks in a fast-moving environment
• Strong sense of responsibility on meeting due/target
• Good interpersonal skills and proven ability to contribute to a team environment
• No reason for disqualification for oversea travels

Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.

Eligibility: All successful applicants must be eligible to work in the country the position is based.

Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to accommodationrequest@dentsplysirona.com.

Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.

Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: careers.dentsplysirona.com.