Regulatory Affairs Specialist II - IVD Submissions & IVDR

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

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.