Global Regulatory Affairs Senior Specialist
Job Description
About the Role
Title: Global Regulatory Affairs Senior Specialist
Location: Sunnyvale California US
Full Time, Temporary
$45-55/hour
Job Description: Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.
Position title: Regulatory Affairs Senior Specialist, Global Market Protection
Workplace: Remote
Shift: M-F, standard working hours
Pay rate: $45-$55/hour
Position type: 1 year contract role
Overview
The Regulatory Affairs Senior Specialist is responsible for serving as the RA lead on product lifecycle management project teams. This role includes completing regulatory reporting assessments for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. The position offers the opportunity to advise project teams on regulatory impacts, devise compliance strategies, and liaise with regulatory bodies during audits. This is a remote position.
Responsibilities
Serve as the lead on product lifecycle management project teams, supporting cross-functional stakeholders in reporting assessments for product and facility changes.
Act as the lead for QMS/Compliance activities, such as audits, Post Market Surveillance, Nonconformances (NC), Corrective and Preventative Actions (CAPA), Field Actions, and complaints.
Collaborate cross-functionally to understand changes, impacts, and implementation requirements in global regions and with the WHO to meet business priorities.
Identify project deliverables and contribute to developing project schedules.
Ensure proper filing and organization of all documents and correspondence supporting market protection regulatory assessments.
Work independently with minimal guidance.
Act as a resource for less experienced colleagues.
Solve complex problems using new perspectives and existing solutions, exercising judgment based on multiple information sources and maintaining a continuous improvement mindset.
Review and approve change orders for anticipated manufacturing, facility, product, and packaging changes in the Product Lifecycle Management Software.
Serve as a business partner for manufacturing, operations, and supply chain to advise on the regulatory impact of product and facility changes.
Qualifications
Bachelor’s degree with 5+ years of related work experience OR Master’s degree with 3+ years of related work experience.
Understanding of Regulatory Affairs concepts and regulations/guidelines governing the development of IVD diagnostic products.
Knowledge of US-IVD, CE-IVDD, CE-IVDR governance for IVD diagnostic products.
Familiarity with QMS, ISO standards, including ISO 13485.
Preferred
Prior knowledge of Agile PLM system, SAP ERP system, and Salesforce-based applications.
Experience in project management.
