Global Regulatory Affairs Specialist - IVD Submissions

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

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.