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Company

MEDIcept Inc. · 7 hours ago

Senior Regulatory Affairs Consultant

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

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Medical Device

No H1B

Hiring Manager

Nick Radoux

Insider Connection @MEDIcept Inc.

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Responsibilities

Work with clients to determine classification and regulatory pathway for US, EU, and other international markets.

Manage multiple, parallel projects to successful completion.

Prepare and submit 510(k)s, Non-filling justifications, Technical Files, Investigational Device Exemptions, and Clinical Evaluation Reports.

Liaise with the FDA on pre-submissions, 510(k)s, and deNovo applications.

Liaise with client’s Notified Body regarding Technical File submissions.

Evaluate and troubleshoot client prepared regulatory submissions.

Labeling / advertising / promotional material assessment.

Qualification

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Regulatory expertiseMedical device experienceEU MDR knowledgeFDA regulations knowledgeMicrosoft products proficiencyRegulatory submissions experienceInternational product approvalsRAC certificationUnique Device Identifier familiarityCLIA license submissions familiarityData analysis skillsCollaborative environment promotionClient interaction skillsAdvanced Project Management

Required

Bachelor’s degree in engineering or a related field, or equivalent experience.

Minimum of fifteen (8) years of related medical device experience.

Knowledge and documented training to EU MDR and/or IVDR inclusive of Clinical Evaluations and Post market Surveillance Reports and FDA regulations required.

Experience with submitting Pre-Submission meeting requests into the FDA and participating in those meetings.

Previous consulting and clientele relationship experience required.

Advanced competency with Microsoft products including Word, PowerPoint, Excel required.

Experience communicating with regulatory agencies and regulatory filings

Experience with assessing device changes for regulatory notification.

Excellent verbal and written communications skills.

Excellent interpersonal skills.

Advanced Project Management

Ability to analyze data and create solutions for challenges.

Strong analytical and problem-solving skills.

Ability to promote a collaborative environment.

Demonstrated ability to interact with all levels of a client organization.