Sr. Regulatory Affairs Specialist - United States
The Sr. Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices in international markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business.
- Negotiate and establish international product submission priorities that are aligned with region/country need; BDB integrated Regulatory Affairs Operating Plan (iRAOP) and Annual Strategic Review (ASR) plans
- Monitor and track international product registrations.
- 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.
- Respond and track the additional information requests (AIRs) submitted by International Regulatory partners.
- Conduct international surveys to understand regulatory requirements and develop international regulatory strategy for new product
- Develop and maintain procedures and/or work instructions for International product registrations.
- Coordinate and collect specific registration information with R&D, Marketing, QA, Medical and other applicable departments as necessary.
- Interface with OEMs to collect specific registration information.
- Interface with applicable regulatory agencies and international consulates.
- Bachelor's degree required, strongly preferred in the biological sciences, chemistry or related science.
- Minimum 3 years’ experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs.
- Ideal candidate will have demonstrated ability to interpret new regulations, and understand and interpret international regulatory requirements for in vitro diagnostic device (IVD)
- Current knowledge of Good Laboratory Practices (GLP) and Quality System Regulations (QSR); and European quality system standards.
- Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
- Ability to prioritize, multi task, and organize work; project management experience desirable.