Project Compliance Manager

Requistion ID: 79295

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.

Compliance Project Manager

In this role, you will ensure Quality and Regulatory Compliance of product development, product modification and product sustaining activities with the applicable international regulations, applicable standards, Sites/Corporate rules, as well as Endo Consumables Group & Corporate procedures and guidelines.

Responsibilities

• Lead or support the maintenance/update of Endodontics Technical Dossiers (TD), Technical Files (TF) and Design History Files (DHF) according to the applicable international regulations and standards (e.g. EU MDR).
• Participate to the MDR Technical Documentation remediation. Create or remediate technical documentation according to 2017/745 EU Regulation. Compile Technical Documentation for submission to the notified bodies according to their respective guidelines.
• Quality & Design Control (HW & SW) within Endodontics, support product design change orders and new product developments as Compliance Project Manager, from feasibility up to commercialization and along the product lifecycle:
  • Provide product development strategy according to the internal possible pathways.
  • Work closely with multifunctional team to ensure compliance with design control, safety, functional goals requirements with a patient related focus in accordance with internal, and applicable external requirements (Corporate, Consumable Group, FDA, MDD, MDR...)
  • Interact with Regulatory Affairs Specialists / Regulatory Project Managers to identify product classification and regulatory pathways for certifications (FDA, CE, INMETRO etc...).
  • Responsible for identifying the applicable standards & regulations (with support of RC) specific to the project.
  • Provide expertise to R&D for the applicable standards and regulations where the CPM is SME (e.g., 62366, ISO 14457, RoHS, WEEE, REACH,ISO 13485, FDA guidelines).
  • Responsible for the conformity to regulation and standards of all product labelling associated to the product (IFU, Brochure, Web etc...) in case the labelling department does not have the appropriate competencies.
  • Review and approve product development deliverables for accuracy and compliance all along the development process (design inputs, V&V, design outputs, marketing claims, risk management, labelling requirements, rationale etc....).
  • Coordinate with the quality team of the manufacturing sites (Supplier control/agreement, transfer to production, process validation, quality controls...)
  • Support product and process change control (Owners = R&D or Ops or QA) to ensure that all changes are:

• Reviewed to ensure adequate approvals at Endodontics Group and at plant level (as applicable).
• Assessed for their impact on TF/TD/DHF (Conduct the TF/TD/DHF update as needed).
• Containing appropriate implementation steps and plans, including validation and product registration requirements.
• Implemented in accordance with the design change plans (Site QA/RA Manager responsible for manufacturing change plans)

• Support as SME the risk activities during the product development and product life cycle according to the applicable procedures and requirements (e.g., ISO 14971).
• Ensure that product risk management process is defined and implemented. Support the risk management multifunctional team.
• Ensure Compliance of Risk Management file with applicable standards requirements.

• Drive the implementation/maintenance of processes the department (Product Compliance) is owner on. Umbrella owner or local site owner for the implementation of the 8000 procedures on the different sites.

• Support sites, group, corporate and regulatory bodies' audits & inspections, more specifically respective to TD, TF and DHF. Elaborate or support necessary answers to address requests or NC from notified bodies.
• Conduct the impact assessment of regulatory and standards changes (When SME), CAPAs & NCs on the TD, TF and DHF. Conduct preliminary impact analysis, inform internal partners and update TDI, TFDL with the cross-functional generated documents (DHF owner = R&D).
• Ensure quality creating the right environment and mindset. Assess needs, organize, and conduct trainings about compliance to processes to other departments when the CPMs are SMEs.
• Propose evolutionary changes and means to insure optimal conduct of his/her tasks and responsibilities.
• Coordinate a task repartition process within the CPM group (e.g., Manufacturing CC repartition etc....).

• Ensure within his/her responsibilities and tasks to reduce the environmental impact of the company and propose improvements.
• Shall take particular care not to endanger his/her own safety or that of his/her colleagues or employees. Every employee is responsible for safety within the company.

Profile requested

• M.S. in biomedical engineering or similar
• Medical Devices is preferred
• Knowledge of dental environment is preferred
• 3-5 years' experience in quality aspects related to product development (with R&D), in medical devices and/or diagnostics or 1-3 years with specific Biomedical Master including Regulatory education.
• Excellent skills (written and spoken) in English (C1). French and/or German would be an advantage.
• Solid experience within international multi-disciplinary R&D organizations in medical device design control and regulations (21 CFR part 820, 93/42/EC Directive, 2017/745 EU Regulation, SOR 98/282), MHLW M.O. 169), quality management standards (ISO 13485) and risk management (ISO 14971).
• Knowledge of international standards requirements according to IEC 62366, 14457.
• Experience in supporting preparation of 510(k)/PMA submissions, EU Technical File compilation and other ROW product registration.
• Comprehension of common scientific and technical documentation.
• Team player with ability to build productive relationships in a dynamic international environment; excellent communication and presentation skills; autonomous, independent, decision-taker, result-oriented, conscientious, and thorough in execution.
• Excellent knowledge of office Suite including OneNote.

As part of our team, you'll experience the spirit of an international and innovative market leader in the dental industry. Besides an attractive remuneration package, you will also be eligable for a variety of employee benefits, such as:

25 days' annual leave (full time basis) and flexible working hours, with the option of hybrid working, so that you can achieve an optimum work-life balance. Enjoy subsidized meals in our company restaurant as well as a coffee allowance and boost your health and wellbeing by taking part in company sports and leisure activities.

We attach great importance to your development: a comprehensive induction, further training opportunities and access to LinkedIn Learning are available to you. Take advantage of personal and professional development opportunities through our global mentoring and coaching program. In addition, we offer an extensive, global employee assistance program that provides a wide range of benefits.

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 Write an email. Please be sure to include "Accommodation Request" in the subject.