Mozarc Medical · 1 day ago

Senior Regulatory Specialist (New England area or Remote)

Portsmouth, RI

Full-time

Remote

Mid, Senior Level

$80K/yr - $132K/yr

4+ years exp

Maximize your interview chances

Health CareMedical

Insider Connection @Mozarc Medical

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Develop and execute global regulatory strategies for new and existing medical devices to ensure compliance with FDA, EU MDR, and other global regulatory requirements

Assess product and process changes, serving as regulatory point of contact on large-scale projects

Manage both devices and kits, ensuring product complies with all global regulations

Assist in the review of product labeling, ensuring compliance with materials of concern and international standards

Review and approve advertising and promotional materials to ensure regulatory compliance

Collaborate with cross-functional teams, including R&D, Quality, and Marketing, to provide regulatory guidance and support throughout the product lifecycle

Interact with regulatory authorities and notified bodies

Assist in the development and maintenance of internal regulatory policies and procedures

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory strategiesFDA complianceEU MDR complianceRegulatory submissionsTechnical filesExcel masterySmartsheetsNotary PublicWindchill experience