Sr. Regulatory Affairs Specialist

Sr. Regulatory Affairs Specialist This role will be primarily responsible for supporting the development of RA strategies for new product development for a range of dental restorative, endodontic, and rotary products, including preparing and submitting regulatory filings for U.S. 510(k)s, Canada, and EU MDR medical devices. Responsibilities Work independently, applying forward-thinking strategies for sustaining and new products, creating action plans and supporting milestone completion. Review and interpret applicable standards, regulations, and directives for dental devices to ensure compliance. Represent the RA function on core teams across cross-functional groups, providing expertise to support project deadlines. Assemble deliverables for domestic and/or international product registration submissions, including 510(k)s, CE Technical Files, and dossiers for international registrations. Execute deliverables related to U.S. and Canada submissions. Ensure product compliance with 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 listings, establishment registrations, and post‑market regulatory documentation. Prepare and lead Health Canada submissions such as MDL applications, amendments, renewals, and supporting technical documentation via the REP process, coordinating responses to regulatory agency requests and deficiency letters. Lead and maintain UDI strategy, implementation, and compliance across product lines, and 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. Author or update department Standard Operating Procedures (SOPs) to address compliance with standards, regulations, etc. Prepare international dossier files. Execute Engineering Change Requests (ECOs) and Engineering Change Reports (ECRs) and perform regulatory assessments. Review labeling and promotional material. Support the execution of regulatory deliverables for clinical studies. Mentor and guide junior RA personnel, supporting their development through training and experience. Maintain expertise of Quality System Regulations and Design Controls as they relate to medical devices. Prepare status reports for Key Performance Indicators (KPIs) for Regulatory Affairs Management. Champion and participate in continuous improvement activities under the Envista Business System (EBS), implementing EBS tools and standard work into RA activities. Execute EBS practices into RA activities and standard work. Incidental Duties The above statements describe the general nature and level of work being performed in this job; additional responsibilities may be assigned as required by management. Physical Demands Constantly sits. Frequently uses hands and fingers. Occasionally walks and stands. Rarely bends and stoops. Occasionally reaches up/down with arms. Occasionally lifts and/or moves up to 5 lbs. Job Requirements Bachelor’s degree in a related field or 7+ years of relevant work experience in medical, pharmaceutical, healthcare, or a regulated industry in lieu of education. 5+ years of Regulatory Affairs experience or equivalent in the medical, pharmaceutical, healthcare, or a regulated industry. Expertise in domestic and/or international medical device regulations, including 510(k)s, EU MDR, and global registration requirements. Must reside within a commutable distance to Brea, CA; this full‑time onsite role is not hybrid or remote. Skills and Abilities Strong technical writing skills and the ability to translate to all levels of employees. Exceptional analytical skills and ability to solve a range of complex problems. Strong professional presentation skills and ability to negotiate effectively. Detail‑oriented with the ability to solve practical problems and handle a variety of variables in situations with limited standardization. Strong project coordination and prioritization skills. Ability to build and maintain good rapport and handle situations with confidence, tact, and resourcefulness. Ability to adapt to changing priorities in a fast‑paced environment. Effective verbal and written communication skills in English. Ability to read and interpret documents in English. Intermediate proficiency with Microsoft Office Suite (Word, Excel, Outlook). Proven success in building and maintaining rapport and handling situations with confidence, tact, and resourcefulness. Assist management with coordination of RA activities as required. Target Market Salary Range $94,500 – $141,800 Operating Company Kerr Equal Employment Opportunity Envista and all Envista companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at #J-18808-Ljbffr