Business Professional - Regulatory Affairs Specialist II

Lancesoft; Fremont (CA); Hybrid; USD 39,000 - 52,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Contributions

Life Insurance

Accident Insurance

Other Employee Perks

Job summary

LanceSoft is seeking a Regulatory Affairs Specialist II in Fremont, CA to draft, assemble, and file regulatory submission materials for new or existing products. The role focuses on international registration of IVD products and ensuring compliance with regulations and guidelines.

The position requires a Bachelor's in a scientific field, 2+ years in regulatory RA/QA/R&D/QC, and strong communication skills. Excellent benefits and a W2 schedule accompany the role.

Qualifications

• Bachelor's 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

Responsibilities

• 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.

Education

Bachelor's degree in science/engineering

Job description

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

• 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.