Regulatory Affairs Specialist

Knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, IVDR and import/export requirements. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients.

Day/Shift: 8 am - 5pm M-F
Duration: 12 Months
Pay range:  $33.00 Hourly - $33.00 Hourly
Onsite Job

Position Summary

The Regulatory Affairs Specialist 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 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 Client 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

Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.