Regulatory Affairs Specialist

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Job description

Job Description

Job Description...
Coordinate, compile, and submit Regulatory documents to competent authorities, notified bodies, Regulatory Agencies, and international business partners. Includes the preparation of key market international documents, including Technical Files.
Work with Management to ensure rapid and timely approval of new products and continued Regulatory support of products marketed outside the United States.
Create detailed international regulatory plans in concert with regional Regulatory contacts.
Evaluate proposed product modifications for international Regulatory impact, completing Regulatory Assessments as needed.
Ensure compliance with applicable international regulations and standards
Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Assist with responses to health authority questions and other Regulatory correspondence.
Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
Update and maintain product eligibility to ensure right product/right country.
Requires use and application of Regulatory concepts, practices and techniques.
Provide solutions to extremely complex problems.
Provide regulatory guidance to project teams, as applicable.
Participate in the review and approval of international product labeling.
Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information
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Diversity, Equality, and Inclusivity This means a deep commitment to each other equally, in an open, diversified team environment. We strive to be as diverse as the clients and employees we partner with. We embrace people of any race, ethnicity, national origin, religion, gender identity, and sexual orientation. LanceSoft is a certified Minority Business Enterprise (MBE).
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