SENIOR REGULATORY AFFAIRS SPECIALIST
San Jose, CA 95115
Location: San Jose, CA
Industry: Medical Equipment / Devices
Company: Top BioPharma/Medical Device Company
Job Category: Legal - Regulatory / Compliance Law
Base Target: $100,000 - $120,000 + Full-time Benefits + relocation assistance possible
Contact: Ken Kupersmith- [email protected]
The Sr. Regulatory Affairs Specialist will be responsible for the preparation of regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in international markets or research use only (RUO) products globally. This responsibility entails development of procedures designed to ensure that the product development process addresses all regulatory requirements and business objectives.
1.Negotiate and establish product submission priorities that are aligned with region/country need; integrated Regulatory Affairs Operating Plan (iRAOP) and Annual Strategic Review (ASR) plans
2.Support product registrations in assigned regions; monitor and track progress.
3.Manage and coordinate the electronic Global Product Submission (eGPS) database to ensure up-to-date, reliable source documents for product registrations are stored, linked, scanned and uploaded into the database.
4.Respond and track the additional information requests (AIRs) submitted by International Regulatory partners.
5.Conduct surveys to understand regulatory requirements and develop regulatory strategy for new products
6.Develop and maintain procedures and/or work instructions for product registrations.
7.Coordinate and collect specific registration information with R&D, Marketing, QA, Medical and other applicable departments as necessary.
8.Interface with OEMs to collect specific registration information.
9.Interface with applicable regulatory agencies and international consulates.
10.Submit and maintain laser registrations for all instruments (IVD and RUO)
11.Prepare Technical files and DoC to support product launches
12.Represent RA in platform core teams as needed
1.Bachelor's Degree required, preferably in a related science.
2.Minimum 3 years' experience in the device/diagnostic or BioPharma industry, preferably in the area of regulatory affairs.
3.Ideal candidate will have demonstrated ability to interpret new regulations, and understand and interpret international regulatory requirements for in vitro diagnostic device (IVD).
4.Current knowledge of Good Laboratory Practices (GLP) and Quality System Regulations (QSR); Laser product registrations; Machinery Directive and European quality system standards.
5.Ability to prioritize, multi task, and organize work; project management experience desirable