Regulatory Affairs Manager (62423)

Dentsply Waltham , MA 02154

Posted 5 months ago

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. As The Dental Solutions Company TM, Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better, safer and faster dentistry. Dentsply Sirona's global headquarters is located in York, Pennsylvania, and the international headquarters is based in Salzburg, Austria. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. This position is located in Waltham, MA, a city along the Charles River in Middlesex County, Massachusetts with rich cultural history that can be explored at various world class monuments, museums and art galleries. The city is a hub for scientific research and higher education with several renowned universities. Waltham also includes numerous high-tech companies and is located in the Boston Route 128 High Technology Corridor only nine miles from Boston which makes this an attractive location to live, work and play.

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.

General Description of the Position:

The Regulatory Affairs Manager is responsible to ensure delivery of the safest and highest quality products while maintaining full regulatory compliance. The Regulatory Affairs Engineer will ensure that the quality, safety, health and environment systems continues to meet FDA, ISO, MDD, MDR, CMDCAS, EPA, OSHA and other appropriate international and domestic standards and regulations.

The Regulatory Affairs Engineer is also responsible to support the Quality Management System in an effort to establish, maintain, and continuously improve the Quality Management System.

Principal Responsibilities:

Reponsibilities may include:

  • Provide support and advise on regulatory pathways and submission strategies

  • Collect and coordinate information and prepare regulatory documentation for submission to various regulatory agencies and advise on the submission strategy;

  • Preparation of document packages for regulatory submissions including 510(k)s Design Dossiers, Device License Applications, Investigational Device Exemptions, and Pre-market Approval applications

  • Creation and maintenance of domestic and international regulatory device and establishment listings, licenses and registrations.

  • Review device labeling, labels and advertising materials for compliance with regulatory requirements and applicable laws

  • Review changes to existing products and procedures to define the requirements for regulatory submissions;

  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products;

  • Maintain a high level of Regulatory intelligence e.g. on existing and developing regulations in the US, CA and EU (key markets);

  • Represent Regulatory Compliance on R&D product development project teams to ensure all regulatory requirements are met throughout the development process;

  • Collaborate and coordinate with divisional and corporate RA management i.e. Mlndal, Sweden & York, PA;

  • Assist in regulatory compliance activities

  • Assist with Quality and Regulatory risk assessment activities

  • Plan and implement assigned projects and activities

  • Assist providing Regulatory and compliance training

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Regulatory Affairs Manager (62423)