Regulatory Affairs Specialist II

. Implement regulatory strategies, including domestic and international submissions, and support product project teams .

Posted 9/24/2026full-timeCovington • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategies for medical devices, including preparation and auditing of submissions such as 510(k), IDE, and PMA. Proficient in managing product life cycle regulatory activities and providing training to regulatory team members.

Highest-signal resume keywords

Regulatory Strategy Development510(k) Preparation and AuditingU.S. and European Medical Device RegulationsCE Marking ActivitiesRegulatory Affairs Certification (RAC)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy Development510(k) PreparationIDE PreparationPMA PreparationTechnical WritingRegulatory Pathway DeterminationProduct Registration SubmissionsChange Control ManagementProduct Technical FilesClinical Evaluations

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationSelf-MotivatedLeadership SkillsMentoring Skills

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Medical Device RegulationsRegulatory ComplianceProduct Life CycleFDA CollaborationProduct LabelingMarketing ClaimsConfidentialityProject ManagementInternational SubmissionsChange Control

About the role

Key responsibilities & impact

Implement regulatory strategies, including domestic and international submissions, and support product project teams
Provide regulatory support throughout the product life cycle
Develop regulatory strategies and timelines, manage change control, and prepare submission-related documents
Prepare and audit 510(k), IDE, PMA, and international submissions
Collaborate technically with FDA and international reviewers and respond to questions
Review and approve product labeling and marketing claims for regulatory compliance
Support CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
Provide training or direction to other regulatory team members
Plan and complete regulatory pathway determinations, product registration submissions, and related documentation

Requirements

What you’ll need

BS in a scientific field
3-5 years employment in medical device product registration
2 or more years supporting regulatory activities through the product life cycle on product project teams
Knowledge of U.S. and European medical device regulations
Experience preparing and auditing 510(k)s, IDEs, PMA and/or international submissions
Experience reviewing and approving product labeling and marketing claims for regulatory compliance
Experience supporting CE marking activities, including product technical files and clinical evaluations
Previous experience training or directing other regulatory team members
Excellent written and verbal communication skills
Self-motivated, able to work independently and take ownership of responsibilities
Ability to prioritize and handle several projects concurrently
Technical writing skills and proficiency compiling submissions for the appropriate audience
Leadership and mentoring skills
Ability to maintain confidentiality with regulatory and clinical documentation
Command of the English language
Ability to plan and complete regulatory pathway determinations, product registration submissions, and other documentation
Ability to operate computer and office equipment
Ability to travel via airlines as needed
Regulatory Affairs Certification (RAC) desired

Benefits

Comp & perks

Flexibility to work 4 days on site and Friday remotely on a weekly basis
COVID-19 vaccination accommodation consideration pursuant to applicable law
Learning, growth, and development opportunities
Face-to-face collaboration and supportive workplace culture