Regulatory Affairs Manager

INSIGHTEC

Regulatory Affairs Manager providing regulatory support for Insightec's incisionless surgery products. Collaborating with global teams to ensure compliance with various regulatory bodies.

Posted 5/12/2026full-timeRemote • Florida, Texas • 🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Serve as US Agent for Insightec
Provide regulatory support to the Clinical and Post marketing activities related to INSIGHTEC products.
Preparation and maintenance of clinical regulatory submissions and registrations of INSIGHTEC products in relevant markets.
Review clinical documents for regulatory appropriateness; Provide review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
Provide ongoing regulatory support and assessments to Promotional materials
Provide support for all external/internal audits at HQ and globally, as needed
Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
Work closely with various other INSIGHTEC teams (e.g. R&D, Clinical, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, and other applicable standards to ensure ongoing regulatory compliance
Attend other regulatory related needs, as required
Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

Requirements

What you’ll need

B.Sc. degree in scientific / technical discipline / engineering.
A minimum of 6 years of Regulatory Affairs experience with the US FDA and EU regulatory agencies
Hands-on experience with Class III medical devices, including IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, and CE Mark submissions
Strong verbal and written communication skills
Ability to work with cross-functional global teams

Benefits

Comp & perks

competitive perks and benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory AffairsClinical regulatory submissionsIDE/INDITA/CTAEU CTAsPMAs510(k)sCE Mark submissionsData reviewRegulatory compliance

Soft Skills

Verbal communicationWritten communicationCross-functional collaborationAdvisory skillsAnalytical skillsAttention to detailProblem-solvingOrganizational skillsInterpersonal skillsTeamwork