Regulatory Affairs

Agilent Technologies

. Ensure global product compliance and adherence to applicable regulatory requirements .

Posted 9/18/2026full-timeRemote • California • United StatesMid-LevelSenior💰 $104,774 - $163,710 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance for IVD products, including knowledge of relevant regulations such as EU 2017/746 and ISO standards. Capable of managing regulatory submissions, documentation, and post-market compliance while collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Regulatory Compliance ExpertiseIVD Regulation KnowledgeExperience with eQMS PlatformsStrong Analytical SkillsProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsTechnical File CompilationRisk AssessmentChange Control ManagementPost-Market SurveillanceRegulatory DocumentationProduct RegistrationCompliance Training DevelopmentComplaint HandlingGap Analysis

Soft Skills

Interpersonal SkillsCross-Functional CollaborationOrganizational SkillsAttention to DetailClear Communication

Tools & Technologies

MasterControlAssurXVeeva Vault QMS

Industry Keywords

IVD Field ExperienceISO 13485:2016ISO 14971:2019MDSAPRegulated Medical Device IndustryInternational SubmissionsAntibody-Based Diagnostics

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Ensure global product compliance and adherence to applicable regulatory requirements
Support regulatory submissions for product marketing in international markets
Provide regulatory input throughout product development from design and development through commercialization
Monitor evolving global regulations and assess their impact on company operations
Maintain regulatory documentation and support post-market compliance
Prepare, coordinate, and submit regulatory documentation and product registrations for the U.S., EU, Canada, LATAM, Asia-Pacific, Middle East, and MDSAP-participating countries
Compile, review, and maintain technical files, GSPRs, and CERs
Partner with R&D, Quality, and Commercial teams on product development, design control, labeling, and change control
Collaborate with Quality Systems on cGMP, GMP/QSR, ISO 13485, and MDSAP compliance
Perform product risk assessments and support complaint and non-conformance investigations
Manage recalls, MDR, advisory notices, and post-market regulatory reporting
Provide guidance on submission planning, global compliance strategies, risk classification, and literature research
Research and interpret global regulations and recommend compliance strategies
Manage product registration, listing, licensing, and business-license renewals
Develop regulatory SOPs, guidelines, templates, and training content; deliver compliance training
Review and approve labeling, IFUs, user manuals, SDSs, and promotional content
Monitor complaint-handling systems and support CAPA management
Track regulatory changes and perform gap analyses
Generate import/export documentation and facilitate customs clearance
Lead or support PMS activities, including complaint trend analysis, vigilance reporting, and PMS documentation under IVDR
Develop and execute PMPF plans and integrate performance data into CERs and risk management
Support internal and external audits and inspections; coordinate responses to findings
Assess regulatory impacts of product and process changes and support change control
Coordinate with external regulatory consultants or local agents and support regulatory project budgeting and planning
Support R&D from concept and feasibility through design, verification/validation, and commercialization
Provide ongoing regulatory support for marketed products, post-market modifications, and lifecycle management

Requirements

What you’ll need

Practical experience in the IVD field, with a solid understanding of regulatory requirements
Knowledge of compliance requirements related to IVD Regulation (EU) 2017/746, NMPA, MFDS, AMDD, and other relevant markets
Familiarity with ISO 13485:2016, ISO 14971:2019, and MDSAP
Strong analytical and problem-solving skills
Effective interpersonal and cross-functional collaboration skills
Strong organizational skills, attention to detail, and ability to manage multiple priorities and deadlines with some guidance
Clear oral and written communication skills
Experience with eQMS platforms such as MasterControl, AssurX, or Veeva Vault QMS
Bachelor’s degree or equivalent experience
Minimum of three years of experience in the regulated medical device, IVD, or a related industry
Strong knowledge of international submissions across LATAM, the EU, Asia, and MDSAP countries
Experience with antibody-based diagnostics is strongly preferred
Excellent leadership, communication, and project management skills
Familiarity with MasterControl, Veeva Vault, or AssurX is highly desirable
Primarily local travel during the business day, with some out-of-area and overnight travel expected
Ability to work in the United States, based on the posting location

Benefits

Comp & perks

Eligibility for bonus
Stock
Benefits
Option to work remotely
Less than 20% travel required