Regulatory Affairs Specialist

Envista Holdings Corporation

Regulatory Affairs Specialist managing FDA 510(k), CE, and international submissions for Envista’s dental products. Assessing compliance impacts across product development and manufacturing changes.

Posted 8/4/2026full-timeThousand Oaks • California • 🇺🇸 United StatesMid-LevelSenior💰 $85,800 - $104,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions for medical devices, including 510(k) and international registrations, while ensuring compliance with US and international regulations. Proficient in preparing clear submission packages and communicating effectively with regulatory authorities.

Highest-signal resume keywords

Medical Device Regulatory Submissions510(k) PreparationRegulatory Strategy DevelopmentISO 13485 KnowledgeFDA Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationTechnical Document WritingRegulatory Impact AssessmentQuality System RequirementsInternational Registration ExperienceRegulatory Guidelines KnowledgeClinical EvaluationsMarketing Communication ReviewCAPA ParticipationDocument Compilation

Soft Skills

Strong Organizational SkillsInterpersonal SkillsPresentation SkillsNegotiation SkillsMultitasking Ability

Tools & Technologies

MS Office ProficiencyQCBD SoftwareComputer File Management Software

Industry Keywords

Global Medical Device RegulationsCE MarkingFDA Medical Device ListingsHealth Canada RegulationsRegulatory Affairs

About the role

Key responsibilities & impact

Plan, prepare, coordinate, track, follow up on, and obtain clearances for global medical device submissions and registrations
Represent Regulatory Affairs on cross-functional project teams throughout product development
Provide regulatory strategy and assess regulatory impacts of design and manufacturing changes
Prepare and compile US, EU, Canadian, and international regulatory submission packages and product registrations
Review and approve marketing communication materials
Provide guidance on global compliance, CE marking, clinical evaluations, ISO 13485, and Canadian requirements
Monitor regulatory and legislative developments and provide impact assessments
Prepare information for Certificates to Foreign Governments and FDA medical device listings
Support FDA, notified body, and international regulator audits
Participate as a CAPA owner, team member, or task owner
Communicate directly with regulatory authorities regarding company filings
Create and update departmental standard operating procedures

Requirements

What you’ll need

Bachelor's Degree (BA/BS) in Engineering, Life Sciences, or a health care-related discipline required
3 years of experience in medical device regulatory submissions required
3 years of experience preparing and submitting 510(k) and international registration documents required
Experience with FDA, Health Canada, and international regulators preferred
Experience supporting international registrations
Knowledge of US and international medical device regulations, guidelines, and policies
Expertise compiling medical device documents into clear submission packages
Expertise writing, reviewing, and editing technical documents
Knowledge of Quality System Requirements and Standards
Excellent MS Office applications proficiency
Knowledge of computer file management software; QCBD preferred
Ability to communicate clearly and write reports and business correspondence in English
Ability to negotiate with regulatory agencies
Strong organizational, interpersonal, and presentation skills
Ability to multitask with a strong sense of urgency

Benefits

Comp & perks

Annual performance bonus
Medical benefits
Dental benefits
Vision benefits
401(k) match