Sr. Regulatory Affairs Specialist
Kerr Corporation, Pomona, CA, United States
Job Overview
The Senior Regulatory Affairs Specialist will be primarily responsible for supporting the development of regulatory strategies for new product development for a range of dental restorative, endodontic, and rotary products. The role will involve preparing and submitting regulatory filings for US 510(k)s, Canada, and EU MDR.
Responsibilities
Draft regulatory strategies for sustaining and new products, creating action plans and supporting milestone completion.
Review and interpret applicable standards, regulations, and directives for dental devices.
Represent the RA function on core cross‑functional teams, providing guidance to support project deadlines.
Assemble deliverables for domestic and international product registration submissions (510(k)s, CE Technical Files, and dossiers).
Execute deliverables related to US 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, eSTAR, Q‑Sub packages, device listing, establishment registration, and post‑market regulatory documentation.
Lead Health Canada submissions (MDL applications, amendments, renewals, technical documentation via REP process) and coordinate responses to regulatory agency requests and deficiency letters.
Lead and maintain UDI strategy and support global UDI requirements.
Manage GUDID submissions, updates, and maintain database accuracy.
Support internal audits, inspections, and regulatory assessments.
Author and update department SOPs to demonstrate compliance with standards and regulations.
Prepare international dossier files.
Execute ECO and ECR and perform regulatory assessments.
Review labeling and promotional material.
Support regulatory deliverables for clinical studies.
Mentor and guide junior RA personnel.
Maintain expertise of Quality System Regulations and Design Controls relevant to medical devices.
Prepare KPI status reports for Regulatory Affairs Management.
Champion continuous improvement activities under the Envista Business System (EBS) and implement EBS tools and practices into RA activities.
Physical Demands
Constantly sits.
Frequently uses hands and fingers.
Occasionally walks and stands.
Rarely bends and stoops.
Occasionally reaches up or down with arms.
Occasionally lifts or moves up to 5 lbs.
Requirements
Bachelor’s degree in a related field or 7+ years of regulated industry experience in lieu of education.
5+ years of Regulatory Affairs work experience or equivalent in the medical, pharmaceutical, healthcare, or regulated industry.
Expertise in domestic and international device regulations, including 510(k), EU MDR, and global registration requirements.
Must reside within commuting distance to Brea, CA. The role is full‑time onsite.
Skills and Abilities
Strong technical writing skills and ability to translate information to all employee levels.
Exceptional analytical skills and ability to solve a range of complex problems.
Strong professional presentation and negotiation skills.
Detail‑oriented problem‑solving in variable situations.
Strong project coordination and prioritization skills.
Ability to build rapport and handle situations with confidence, tact, and resourcefulness.
Adaptability to changing priorities in a fast‑paced environment.
Effective verbal and written communication skills in English.
Proficient with Microsoft Office Suite: Word, Excel, Outlook.
Assistance with coordination of RA activities as needed.
Compensation
The total compensation package for this position may include base salary, annual performance bonus, medical/dental/vision benefits, 401(k) match, and other applicable plans.
Salary range: $94,500 – $141,800
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: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
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The Senior Regulatory Affairs Specialist will be primarily responsible for supporting the development of regulatory strategies for new product development for a range of dental restorative, endodontic, and rotary products. The role will involve preparing and submitting regulatory filings for US 510(k)s, Canada, and EU MDR.
Responsibilities
Draft regulatory strategies for sustaining and new products, creating action plans and supporting milestone completion.
Review and interpret applicable standards, regulations, and directives for dental devices.
Represent the RA function on core cross‑functional teams, providing guidance to support project deadlines.
Assemble deliverables for domestic and international product registration submissions (510(k)s, CE Technical Files, and dossiers).
Execute deliverables related to US 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, eSTAR, Q‑Sub packages, device listing, establishment registration, and post‑market regulatory documentation.
Lead Health Canada submissions (MDL applications, amendments, renewals, technical documentation via REP process) and coordinate responses to regulatory agency requests and deficiency letters.
Lead and maintain UDI strategy and support global UDI requirements.
Manage GUDID submissions, updates, and maintain database accuracy.
Support internal audits, inspections, and regulatory assessments.
Author and update department SOPs to demonstrate compliance with standards and regulations.
Prepare international dossier files.
Execute ECO and ECR and perform regulatory assessments.
Review labeling and promotional material.
Support regulatory deliverables for clinical studies.
Mentor and guide junior RA personnel.
Maintain expertise of Quality System Regulations and Design Controls relevant to medical devices.
Prepare KPI status reports for Regulatory Affairs Management.
Champion continuous improvement activities under the Envista Business System (EBS) and implement EBS tools and practices into RA activities.
Physical Demands
Constantly sits.
Frequently uses hands and fingers.
Occasionally walks and stands.
Rarely bends and stoops.
Occasionally reaches up or down with arms.
Occasionally lifts or moves up to 5 lbs.
Requirements
Bachelor’s degree in a related field or 7+ years of regulated industry experience in lieu of education.
5+ years of Regulatory Affairs work experience or equivalent in the medical, pharmaceutical, healthcare, or regulated industry.
Expertise in domestic and international device regulations, including 510(k), EU MDR, and global registration requirements.
Must reside within commuting distance to Brea, CA. The role is full‑time onsite.
Skills and Abilities
Strong technical writing skills and ability to translate information to all employee levels.
Exceptional analytical skills and ability to solve a range of complex problems.
Strong professional presentation and negotiation skills.
Detail‑oriented problem‑solving in variable situations.
Strong project coordination and prioritization skills.
Ability to build rapport and handle situations with confidence, tact, and resourcefulness.
Adaptability to changing priorities in a fast‑paced environment.
Effective verbal and written communication skills in English.
Proficient with Microsoft Office Suite: Word, Excel, Outlook.
Assistance with coordination of RA activities as needed.
Compensation
The total compensation package for this position may include base salary, annual performance bonus, medical/dental/vision benefits, 401(k) match, and other applicable plans.
Salary range: $94,500 – $141,800
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: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
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