Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Re
# Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Re **Illumina** · United States · `Remote` · `Full Time` 💼 **Уровень роли:** `Senior` 💰 **Компенсация:** `$90,000 – $135,000` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Regulatory-Affairs-Specialist]` `[Regulatory-Compliance-Specialist]` `[IVD-Regulatory-Affairs]` `[Post-Market-Compliance-Analyst]` `[Senior-Regulatory-Affairs]` --- ### About the Role What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina , we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets. This role is responsible for supporting post-market regulatory compliance activities, including adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments. The individual will serve as a key regulatory partner to cross-functional teams, providing guidance on regulatory requirements, risk evaluations, and reporting obligations. Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing regulatory justifications and documentation, and ensuring compliance with applicable global regulations. The role will also contribute to continuous improvement initiatives through the development and implementation of regulatory procedures, work instructions, and best practices that strengthen post-market compliance and regulatory oversight. Responsibilities: - Represents the RA function on assigned cross-functional project teams - Interprets and applies regulations by creating regulatory strategies for domestic and international markets - Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations - Prepares hardcopy and electronic information packages for submission to regulatory agencies - Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance - Reviews validation, clinical and stability protocols and reports for regulatory submission soundness - Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations - Defines, monitors and receives deliverables for submissions - Writes and/or edits submission documents using regulatory templates, or creates new templates - Assembles paper and/or electronic copies for submission - Monitors new and revised regulatory requirements; disseminates information as directed by management - Interacts with regulatory agencies and third party accrediting bodies - Prepares internal procedures for continuous process improvement - Provides regulatory guidance and/or training to external departments and partners Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Experience/Education: - Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience Preferred Experiential Background: - 5+ years experience in Regulatory Affairs - Experience with an in vitro diagnostics device company preferred; pharmaceutical, biologics or medical device companies as alternative - Strong understanding of FDA regulations required; other international requirements - EU, Canada, Australia, Japan and China - preferred - Demonstrated ability to work independently with new, complex technologies and produce professional work products - Strong written and verbal communication skills - Team leadership skills preferred - Familiarity and ability to work with office automation programs and corporate database tools - Strong work ethic and demonstrated ability to deliver assignments on time Originally posted on Himalayas
- Regulatory-Affairs-Specialist
- Regulatory-Compliance-Specialist
- IVD-Regulatory-Affairs
- Post-Market-Compliance-Analyst
- Senior-Regulatory-Affairs
Наблюдалась 2026-10-14, впервые 2026-10-14, источник — Himalayas (JSON API).