Regulatory Affairs Specialist

Lancesoft; Fremont (CA); On-site; USD 38,000 - 53,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision Insurance

401k Contributions

Critical Illness Insurance

Life Insurance

Accident Insurance

Other Perks

Job summary

LanceSoft is seeking a Regulatory Affairs Specialist in Fremont, CA to draft, assemble, and file regulatory submissions for new or existing products. You will ensure accuracy, high quality literature support, and compliance with applicable regulations, facilitating timely reviews.

The role supports international registrations for IVD products, coordinating information, maintaining files, and preparing documents for submissions. Strong communication and regulatory knowledge are essential.

Qualifications

• 2+ years of experience in regulatory environment – RA/QA/R&D/QC.
• Working knowledge and experience with IVD products.
• Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, IVDR and import/export requirements.
• Strong oral and written communication skills.

Responsibilities

• 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.

Skills

Regulatory experience

IVD knowledge

Documentation drafting

Communication skills

Team collaboration

Education

Bachelor's degree in a scientific, engineering or related field

Tools

Regulatory documentation systems

Job description

Day/Shift: 8 am - 5pm M-F

Duration: 12 Months

Pay range: $33.00 Hourly - $33.00 Hourly

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.