RA Specialist, Korea - Seoul - Dentsply Sirona와 관련된 현재 작업
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RA Specialist, Korea
2 개월전에
Requistion ID : 77972
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. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. This position is located in York, Pennsylvania.Offering the cultural attractions of a big city and the down-home charm of a small town, York, PA is an extraordinary place to live, work and play.
York is located in south-central Pennsylvania and is within 25 miles of Gettysburg and Lancaster, 45 miles of Baltimore and Hershey, and 100 miles of Washington, DC and Philadelphia.
Engrained with a rich history and heritage and becoming one of the fastest growing cities in Pennsylvania, York is a place where the past and the present comfortably coexist.
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.
SUMMARY OF POSITION:
- Ensure timely registration of new product registration & Maintenance of existing product license
- Compliance with MFDS & Corporate requirements
- Management of KGMP audit 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 KGMP certificates, labeling, 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 managers.
- Actively participate in industry meetings and MFDS explanatory conferences, share the information from these meetings with the team and other departments
- Coordinate the execution of local development and post-marketing studies when applied
- Ensure all activities comply with legal & ethical standards as well as company policies
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
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 ) . Please be sure to include "Accommodation Request" in the subject.
For California Residents:
We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes).
The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).
