MEDIcept Inc. · 4 hours ago
Senior Regulatory Affairs Consultant
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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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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.
Must be legally authorized to work in the U.S.
Preferred
Experience with international product approval/registrations, such as UK, China, Brazil, Japan, India, and Australia a plus.
RAC certification a plus.
Familiarity with Unique Device Identifier a plus.
Familiarity with CLIA license submissions a plus.
Company
MEDIcept Inc.
MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions.
Funding
Current Stage
Early StageRecent News
Med-Tech Innovation
2024-05-23
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