Next Level Impacts · 12 hours ago

Senior Regulatory Affairs Specialist

United States

Full-time

Remote

Senior Level

5+ years exp

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Staffing & Recruiting

Hiring Manager

Keith Roher

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Responsibilities

Act as a regulatory advocate for project teams and contractors.

Guide and support product lifecycle activities, ensuring compliance with U.S. FDA regulations, ISO 13485, and other standards.

Participate in regulatory submissions, including U.S. FDA Q-Submissions and Pre-market applications.

Draft and review technical protocols, validation documents, and product labeling.

Support management of the Quality System, including adverse event reporting and product recalls.

Evaluate regulatory impacts of product changes and assist in risk management activities.

Assist in managing third-party and internal quality audits.

Qualification

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FDA regulationsISO 13485Quality AssuranceRegulatory AffairsCGMP/QSRsMedical device regulationsFluency in EnglishFluency in KoreanProject management

Required

Bachelor’s degree in Engineering, Biology, Biochemistry, Microbiology, or a related field.

5-6 years in FDA/ISO-regulated industries, with experience in Quality Assurance, Regulatory Affairs, and medical device design and manufacturing regulations.

Fluency in English and Korean.

Extensive knowledge of cGMP/QSRs, FDA device regulations, and ISO standards.

Must demonstrate strong leadership, problem-solving, and project management abilities.