Medtronic · 18 hours ago

Senior Regulatory Affairs Specialist

Lafayette, CO

Full-time

Remote

Mid, Senior Level

$89K/yr - $133K/yr

4+ years exp

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Responsibilities

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

Leads or compiles all materials required in submissions, license renewal and annual registrations.

Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

Monitors and improves tracking / control systems.

Keeps abreast of regulatory procedures and changes.

May direct interaction with regulatory agencies on defined matters.

Recommends strategies for earliest possible approvals of clinical trials applications.

Additional tasks as assigned

Qualification

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Regulatory AffairsEU MDR ComplianceMedical Device Experience510(k) PathwayQuality Management SystemsISO 13485Advanced DegreeDocument Preparation

Required

Bachelor’s degree with 4+ years of experience in regulatory affairs

An advanced degree with 2+ years of experience in regulatory affairs

Preferred

4+ years of medical device regulatory affairs experience

Local to CO and willing to work hybrid for this role

Experience with global regulatory pathways such as 510(k) and EU MDR

Background or coursework in quality systems, including familiarity with ISO standards (e.g., ISO 13485), and experience with Quality Management Systems (QMS)