Job Description

Position Summary
The Regulatory Affairs Specialist II will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines


Key Responsibilities:
The Regulatory Affairs Specialist II will join existing team and provide support for International Registration of IVD products.
Tasks will include
Initiation, collection, and coordination of information of regulatory documents for various purposes.
Preparation and maintenance of product technical files for CE marking
Organization and preparation of documents for international submissions, including drafting reports, and preparing documentation for submissions
Coordination with international counterparts to obtain product approvals and renewals.
Maintaining logs and trackers.
Organize, update, and maintain regulatory documentation in accordance with department and company procedures.


Minimum Requirements:
Bachelors degree in a scientific, engineering or related field is required
2+ years of experience working in regulatory environment RA/QA/R&D/QC
Working knowledge and experience with IVD products
Knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, IVDR and import/export requirements
Strong oral and written communication skills

Job Tags

Hourly pay

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