Senior Regulatory Affairs Specialist

Saluda Medical

Senior Regulatory Affairs Specialist preparing regulatory submissions and providing guidance for new products at Saluda Medical, which develops treatments for chronic neurological conditions.

Posted 8/1/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs within the medical device industry, including the management and submission of regulatory filings, compliance with ISO standards, and collaboration with cross-functional teams. Strong analytical skills and attention to detail are essential for ensuring accuracy in technical documentation and adherence to regulatory requirements.

Highest-signal resume keywords

Regulatory Affairs ExperienceMedical Device RegulationsISO Standards KnowledgeRegulatory Submission ManagementCross-Functional Team Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationTechnical Documentation ReviewRegulatory Compliance MonitoringLabeling Content DevelopmentAdvertising Material Review

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationEffective Time ManagementSelf-Motivated Team PlayerAnalytical Skills

Industry Keywords

Medical Device IndustryTherapeutic GoodsActive Implantable DevicesClass III Medical DevicesAustralian Reimbursement Requirements

About the role

Key responsibilities & impact

Prepare submissions for regulatory authorities
Liaise with regulatory authorities for applications under review, and coordinate responses to queries
Maintain product and site licenses, registrations, certificates, and listings
Work closely with the Product Development team, providing regulatory guidance and input into the design of new products
Assess proposed design, quality, and production changes to determine regulatory submission strategies
Review technical documentation for accuracy and completeness to support regulatory submissions
Monitor and review updates to regulations, standards, and guidance documents to ensure ongoing compliance to regulatory requirements
Assist with development of labelling content and review for compliance prior to release
Assist in the review of advertising and promotional materials in accordance with national regulatory requirements
Provide mentorship for junior RA Specialists and interns

Requirements

What you’ll need

Tertiary qualification in a science or engineering related discipline (e.g. software, biomedical, mechanical)
Experience in medical device or other therapeutic goods industry, preferably in regulatory affairs
Broad understanding of medical device regulations and relevant ISO standards associated with the product development and approval process
Demonstrated experience in the management, compilation, submission, and maintenance of regulatory filings
Proven experience working with cross functional teams in a commercial environment
Strong written and verbal communication skills
Effective time management and the ability to work autonomously
Self-motivated team player, with a high level of personal integrity
Demonstrated analytical skills and strong attention to detail to identify and resolve problems
A strong desire to contribute to the growth of the company
Experience with European, US and/or Australian Medical Device Regulations (desirable)
Experience with Active Implantable and/or Class III medical devices (desirable)
Experience with Australian reimbursement requirements (desirable)

Benefits

Comp & perks

Saluda Medical embraces diversity and equal opportunity
Committed to building a team representative of various backgrounds, perspectives, and skills
Belief that people are the source of inspiration and innovation