Regulatory Compliance Manager - Milford, DE 19963 at Dentsply Sirona in Milford, Delaware

Job 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. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. This position is located in the heart of Southern Delaware; located just 25 miles north of Rehoboth Beach and only 20 miles south of the state's capital, Dover. Also, we are centrally located east and south of Baltimore, Philadelphia and Washington DC. Whether standing at a scenic point along the downtown River walk, or spending the day at one of Delaware's beautiful beaches, know that underneath the calm tranquility is the energy of a community on the move!

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

This position is responsible for keeping Dentsply Sirona Milford domestic and export markets accessible through domestic and international product and license submissions. This position is responsible for implementation, management and sustainment of regulatory system elements to ensure conformity with US FDA, EU, ISO, CMDCAS, JPAL and other applicable regulatory requirements. This position serves as a leader in the QA/ RC Team and the Milford Site. This position works under the direction of the Vice President of Quality Assurance & Regulatory Compliance and is responsible for ensuring regulatory requirements are met and ensure compliance with laws and regulations worldwide and keeping export markets open.

Key Responsibilities

• Serve as a leader in the QA/RC Team and the Milford Site.
• Supervise the daily activities of regulatory affairs associates
• Responsible for development of Regulatory Strategy and implementation plan for new product development projects (including core markets US, Canada and EU) with assistance from the Director of Quality Assurance & Regulatory Compliance. Represent RA on new product development teams.
• Develops new product dossier preparation
• Coordination and development of 510ks, etc
• Develops legacy product dossier preparation
• Maintenance of country specific product and site registrations including participating and / or leading country desktop audits
• Creation, maintenance and approvals of all core Regulatory documents including: Device Master Records, European Technical Files, Japan and other Country specific documentation as applicable.
• Preparation, coordination and compiling for all US FDA 510(k) submissions. Lead strategy efforts for determination of classification and conformity assessments.
• Train Regulatory team in regulatory policies and procedures.
• Maintain current knowledge of relevant regulations including proposed guidance and final ruling. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or commercialization of products.
• Interface with the several International Groups including Regulatory RCOs, Commercial 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.
• Review and approve all labeling (including Marketing literature, packaging, DFUs, labeling and claims matrices) in conjunction with the Director of Quality Assurance & Regulatory Compliance.
• Responsible for Regulatory Assessments and strategy of implementation of changes for product life cycle changes (PCO/Change Control assessment)
• Maintain ClearTrack database all international and domestic regulatory submissions
• Serve as a Lead Internal Auditor
• Serve as a Licensed Notary
• Supports Quality Site Leaders during inspections / audits by Corporate, Notified Bodies, FDA and other international regulatory bodies.
• Maintain the Corporate RSMP for all Milford products
• Report FDA establishment registration changes to Corporate. Report FDA Medical Device Listing changes/additions to Corporate
• Lead and / or carry out special assignments / projects in broad areas upon request of QA/RA management.
• Develop and implement systems to measure and increase regulatory compliance.
• Handle general Regulatory Affairs requests from international countries and within the Consumables group
• Other duties as assigned

Education/Experience

• Bachelor's degree (B.A.) from a four-year college or university and minimum of 3 years of Regulatory Affairs experience
• Equivalent combination of education and experience.
• Licensed Notary preferred

Key Required Skills, Knowledge and Capabilities:

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. 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.
• COMPUTER SKILLS:
  
  
  • Internet software
  • Spreadsheet software
  • Word Processing software
  • SmartSolve
  • LMS
  • ClearTrack
  • Tarius
  • Accolade
  • BPCS
  • TrackWise
  
  

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 careers@dentsplysirona.com. 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).

For additional details and questions, contact us at careers@dentsplysirona.com