Founded in 2007, Dental Wings is headquartered in Montreal (CA), with additional offices in Berlin, Chemnitz (D), Lyon (F), and Shenzhen (CN). A fully-owned company of the Straumann Group since August 2017, Dental Wings products are distributed by leading dental companies in over 70 countries around the world.

Our products cover the full digital workflow from treatment-planning to final restoration including intraoral scanning, implant planning, prosthesis design, manufacturing, and communication among dental professionals.

The RA Specialist provides Canadian and international regulatory support to cross-functional new product and new marketing teams.

The RA Specialist authors regulatory submissions, reviews labeling and marketing materials, evaluates proposed device changes for regulatory considerations. He-She is capable of leading and supporting the preparation, submission, and maintenance of global product registrations with a focus on U.S. 510(k)s, EU Technical Files.

• Monitors and analyzes information release and activity pertaining to federal, state, and industry standards as it relates to regulatory compliance.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, registrations and legal information for labels, compile and prepare materials for submission to regulatory agencies.
• Assess changes to marketed devices, determine effects of product improvements and innovation on regulatory global regulatory status.
• Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as labeling changes.
• Advise project teams on subjects such as pre-market regulatory requirements, export and labeling requirements.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
• Provide information to prepare pre-submission meetings, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Review protocols and applied studies to ensure collection of data needed for regulatory submissions.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Coordinate recall or market withdrawal activities as necessary.

QUALIFICATIONS:

The ideal candidate has an engineering degree (electrical, software) and practical experience in medical device licenses, 510(k)s, Technical Files.

History of successful 510(k) device submissions and other worldwide submissions and clearances.

Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports.

Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting.

Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.

Ability to compile data and summarize results

The applicant will have knowledge and experience with FDA submissions, ISO certifications and MDR (Europe’s new Medical Devices Regulation 2017/745) requirements.

Notez que nos bureaux sont temporairement déménagés au centre-ville de Montréal à la station Place d'armes. Nos nouveaux bureaux seront à Laurier.

Possibilité de travail à distance.