Job description
Our client stresses innovation and good health and is a global leader in its space. The R/A Specialist is responsible for supporting the preparation of regulatory submissions and assisting international business partners with product registrations; preparation of technical files; provide change notifications to foreign distributors and notified bodies; provides regulatory support to lifecycle management and new product development/new product introduction and international product registrations.
In this position the candidate will use their experience to:
- Under supervision, coordinate, compile, and submit regulatory documents to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files.
- Work with R/A Manager to ensure rapid and timely approval of new products and continued regulatory support of products marketed outside the United States
- Work to support and ensure regulatory compliance across LATAM region for a broad product portfolio including medical devices, consumer packaged goods, drugs and cosmetics.
- Assist with the development of the LATAM regulatory strategy collaborating with appropriate functional partners and contribute to business strategy.
- Support and make recommendations for projects by working closely with LATAM functional partners and Manager Regulatory Affairs to move projects from discovery to launch.
- Under supervision, 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.
- Under supervision, prepare 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 FDA/Health Canada Establishment Registration and Listing, as well as State licensing
- Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.
- Review and approve promotional materials.
The ideal candidate will possess:
- BS in Science/Technology or higher
- Minimum of 2 years of related experience with Medical Devices
- Direct experience with international medical device/cosmetic/drug registration (especially Brazil, Colombia, Argentina, Mexico, Canada and Europe) is desired
- Minimum 1 year of experience with 21 CFR 820, 807, 11, 701; ICH, ISO 13485:2016 and ISO 14971
- Familiarity with application of US Federal Food, Drug, and Cosmetic Act (FD&C), Section 510(k) is required.
- Experience in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is required; EU MDR familiarity is desired.
- Working knowledge of Regulatory Authority computerized submission systems
- Solid writing ability and good verbal communication skills
- Proficiency in MS Office
- Good interpersonal and organizational skills
Abilities
Ability to read, interpret and appropriately apply regulations and guidance to support regulatory submission in US, Europe, Canada and LATAM regions. Ability to set and meet goals and perform job responsibilities under supervision of Manager, Regulatory Affairs.
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