Regulatory Affairs Specialist (63189)
USA - Pennsylvania
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.
REGULATORY AFFAIRS SPECIALIST
This position is responsible for keeping Dentsply Sirona (Labs) group domestic and export markets accessible through domestic and international product and license submissions. The position also supports the internal auditing functions of the Regulatory Affairs Department and local site activities as needed.
KEY RESPONSIBILITIES / ESSENTIAL FUNCTIONS:
- Interface with the several International Groups including Regulatory RCOs, Commercial SBU and RCOs, Corporate staff, external customers/distributors, and foreign government officials to open and maintain both domestic and international regulated markets through the preparation and submission of required documents and product samples for registration in foreign countries. Interface with several cross-functional teams including R&D, Marketing, Clinical and Operations.
- Responsible for new product dossier preparation and successful clearance.
- Responsible for legacy product dossier preparation and successful clearance.
- Responsible and accountable for all Labs group EU Technical files for the Germany site.
- Serve as a Lead Internal Auditor for local site.
- Represent Regulatory Affairs on new product development teams.
- Lead general Regulatory Affairs requests from foreign countries and within the Labs group.
- Creation, maintenance and approvals of all core regulatory documents including: Device Master Records, European Technical Files, Japan Seihin Hyojun Sho and other Country specific documentation as applicable.
- Maintenance of country specific product and site registrations including participating and / or leading country desktop audits.
- Review and approve all labeling (including marketing literature, packaging, DFUs, labeling and claims matrices).
- Responsible for regulatory assessments and strategy of implementation of changes for product life cycle changes (Change Control assessment).
- Responsible for maintenance of ClearTrack database all international and domestic regulatory submissions.
- Creation and / or maintenance of regulatory files (example: STED files, site specific).
- Provide support in maintenance and submission of data in the GUDI database.
- Participate in both internal and external audits (including but not limited to Notified Body, FDA, and Inter-Divisional Corporate audits).
- Produce accurate monthly reports for inclusion into overall reporting scheme.
- Lead or facilitate special assignments / projects in broad areas upon request of QA/RA management.
- Serve as a back-up for local document control activities as needed.
- Other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Strong written and verbal coimmunications skills required.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to write speeches and articles for publication that conform to prescribed style and format.
- Ability to effectively present information to top management, public groups, and/or boards of directors.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Strong computer skills including but not limited to:
- Intermediate to advanced proficiency in Microsift Office, including but not limited to Word, Excel, Powerpoint, etc.
- Smart Solve
- Other QA / RA software packages as required.
EDUCATION AND EXPERIENCE:
- Bachelor’s Degree (B.A. or B.S.) or equivalent preferred in Quality / Regulatory Affairs, Engineering, Technical or related field
- 3 to 5 years previous experience in Regulatory Affairs or related industry preferred