Business Professional - Regulatory Affairs Specialist II

Description:
 
Title:                 Regulatory Affairs Specialist II
Location:        Fremont, CA – 94538
Duration:        0–12+ Months
Pay Rate:        $33.00/Hour on W2
Schedule:       8 am - 5pm M-F
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 skill
 
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

EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal-opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.