Senior Regulatory Affairs Process Specialist

Jobvertise.com - Jobboard; Sunnyvale (CA); Remote; USD 141,000; Full time

Job summary

A leading company in regulatory affairs is seeking a Senior Regulatory Affairs Process Specialist in Sunnyvale, CA. This role involves overseeing regulatory assessments, supporting global expansion projects, and improving processes related to change notifications. Candidates should possess a relevant degree and significant experience in global regulatory affairs. Telecommuting is an option for applicants based in the U.S.

Qualifications

• Five years as a Regulatory Affairs Specialist or three years with a master's degree.
• Experience in global regulatory affairs and compliance with US, EU, and RoW regulations.
• Expertise in IVD development and maintaining regulatory submissions.

Responsibilities

• Review and assess change orders and perform regulatory assessments.
• Support IVDR launch activities and improve change notification processes.
• Prepare submission documents and interact with global regulatory leaders.

Skills

Regulatory Affairs

Change Notifications

Technical Assessments

Improvement Processes

Education

Bachelor’s degree in Biology, Chemistry, Microbiology, Pharmacology, or related field

Master’s degree in relevant field

Tools

ERP Systems

PLM Documentation Systems

UDI Management Software

Job description

Senior Regulatory Affairs Process Specialist for Cepheid in Sunnyvale, CA to work with Regulatory Affairs Process group to review change orders and perform regulatory assessments as applicable in the QMS. Support IVDR launch activities and global expansion projects. Understand changes from a technical perspective and anticipate the needs and questions from international Ministry of Health. Process change notifications in Agile. Prepare change notification letters and provide memos and support reports for change notification submissions. Work with cross-functional teams to improve the change notification process and provide training for process updates. Regulatory review and approval of design, manufacturing, labeling, packaging, etc. related changes in compliance with applicable regulations and providing Regulatory Change Assessments through (RCA). Track regulatory impact for anticipated changes in regulatory database and support team to maintain accurate listing of blocked and released product within the ERP system (SAP). Investigate and implement continuous improvement to regulatory processes, change notification submissions and change tracking reports. Interact with departments to generate work instructions, protocols and report templates to expedite submission process and reduce the review timelines by the agencies. Develop solutions to improve processes for regulatory submissions and tracking. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking, documentation for submissions and regulatory blocks/approvals. Interact with global regulatory leaders and peers to share and lead department metrics and KPIs and communicate registration status.

Requires: Bachelor’s degree in Biology, Chemistry, Microbiology, Pharmacology, Regulatory Affairs in Life Sciences or related field (willing to accept foreign education equivalent) plus five (5) years of experience as a Regulatory Affairs Specialist or in a related occupation involving global regulatory affairs, including international admissions and regulatory codes or, alternatively, a master’s degree in Biology, Chemistry, Microbiology, Pharmacology, Regulatory Affairs in Life Sciences or related field (willing to accept foreign education equivalent) and three (3) years of experience as a Regulatory Affairs Specialist or in a related occupation involving global regulatory affairs, including international admissions and regulatory codes. Experience must include: Applying technical/scientific principles that relate to multiple, diverse, or complex product lines or manufacturing processes of In Vitro Diagnostics (IVD) development and manufacturing; ERP and PLM documentation systems; US, EU (IVDD and IVDR) and RoW regulatory requirements; UDI program management; Identifying significant changes that require notification to EU or related world health authorities; Updating FDA establishment registrations and device listings for IVD products; Maintaining and administering regulatory dossier management system; Product registration renewals globally; Assigning GMDN and UDI (GTIN) codes to IVD products; Maintaining and administering UDI Management software; Submitting new products to country specific UDI databases; and Identifying process improvements and work cross-functionally to develop standard work. Telecommute Benefit: Remote - May work from anywhere in U.S. Salary range $114,700 - $200,800. Salary: $140,504. CV to [e-mail] & reference job title.

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