The Sr. Regulatory Affairs Specialist will support the development of RA strategies for new product development for a range of dental restorative, endodontic, and rotary products. Responsibilities include preparing/submitting regulatory filings for US 510(k)s, Canada, and EU MDR.
Requirements
- Prepare/submit regulatory filings for US 510(k)s, Canada, and EU MDR.
- Review and interpret applicable standards, regulations, and directives for dental devices to ensure compliance with applicable regulations.
- Represent the RA function on core teams with cross-functional teams and apply expertise when providing RA guidance to support project deadlines.
- Assemble the deliverables of domestic and/or international product registration submissions.
- Ensure products comply with applicable FDA regulations (21 CFR), Health Canada Medical Device Regulations, and international standards.
- Prepare, review, and submit U.S. FDA submissions, including: 510(k)s (e-star), Pre-submission (Q-Sub) packages, Device listing, establishment registration, post-market regulatory documentation
- Prepare and lead Health Canada submissions, such as: Medical Device License (MDL) applications; Amendments, renewals, and supporting technical documentation via the REP process;
- Support global UDI requirements through collaboration with internal teams and external partners
- Manage GUDID submissions, updates, and ongoing database accuracy.
- Support internal audits, inspections, and regulatory assessments.
- Authors/updates department Standard Operating Procedures (SOP) to address and demonstrate compliance to standards, regulations, etc.
- Executes deliverables related to preparing international Dossier files.
- Executes Engineering Change Request (ECO) and Engineering Change Reports (ECR) and performing regulatory assessments.
- Reviews labeling and promotional material.
- Supports the execution of regulatory deliverables for clinical studies.
- Mentors and guides junior RA personnel.
- Maintains expertise of Quality System Regulations and Design Controls and their relevance to medical devices.
- Prepares various status reports for Key Performance Indicators (KPI) reporting to Regulatory Affairs Management.
- Champions and participates in continuous improvement activities under the Envista Business System (EBS) and supports the implementation of actions.
Benefits
- Medical/dental/vision benefits
- 401K match
