The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements. The Regulatory Affairs Specialist provides direct Worldwide Regulatory support to lifecycle management and new product development/new product introduction international product registrations., The Regulatory Specialist II, will: Coordinate, compile, and submit Regulatory documents to compet... more details
Regulatory Affairs Specialist
The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements. The Regulatory Affairs Specialist provides direct Worldwide Regulatory support to lifecycle management and new product development/new product introduction international product registrations., The Regulatory Specialist II, will:
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.
Qualifications
A Bachelor’s degree is required, preferably in a science or technical discipline. A minimum of 4 years of related Regulatory experience is required.
Familiarity with Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299)
Experience in the application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is preferred.
Familiarity in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and CE marking is required; EU MDR familiarity is preferred.
Experience in the application of Quality Management System Standard ISO 13485.
Direct experience with international medical device registration is required.
Experience with change assessments for internationally marketed medical devices is preferred.
Demonstrable track of successfully managing multiple projects simultaneously is required.
Previous experience working with globally dispersed affiliates and stakeholders is preferred.
Excellent English written and oral communication skills are required.
Good analytical thinking, problem solving, and investigative skills are required.
Ability to lead others.
Proficiency in Microsoft Office and all related applications is required.
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