Regulatory Affairs Specialist - Lake Forest, CA

We are seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions.This role will support execution of global regulatory strategies, ensure compliance with FDA, EU, and international requirements, and collabor ...

We are seeking a Regulatory Affairs Specialist (RAS) with strong IVD experience to support the transition from IVDD to IVDR. This role is responsible for revising and maintaining IVD technical documentation, supporting IVDR labeling conversions, and managing regulatory notificati ...

Job Summary · The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and ...

We are seeking a Sr Regulatory Affairs Specialist to join our mission-driven Regulatory Affairs team. · Develop implement and maintain regulatory processes SOPs with a strong commitment to Integrity ensuring compliance with current evolving global regulations prioritizing product ...

The Sr. Regulatory Affairs Specialist will support develop drive timely preparation regulatory submissions updates necessary obtain maintain regulatory approvals Endologix products. · This position will support regulatory strategy review design changes manufacturing changes speci ...

As a Regulatory Affairs Specialist III, you will execute global strategies and submissions to obtain market authorization for new products and modifications. The position partners cross-functionally with R&D, Quality Marketing, RA Operations, and regional regulatory teams to ensu ...

Sr. Specialist, Regulatory Affairs · Salary Range: $91,628 - $120,263 · (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs ...

Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements ...

Sr. Specialist, Regulatory Affairs · Salary Range: $91,628 - $120,263 · (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs ...

This role will focus on supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities impacting all products currently CE Marked under the IVD Directive. · ...

Job Title: · Regulatory Affairs Specialist II · Join our client's Regulatory Affairs team to support the transition to the EU's In Vitro Diagnostic Regulation (IVDR), impacting all CE-marked IVD products. · ...

Job Summary · The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and ...

Regulatory Affairs Specialist II · Location: Irvine, CA (Hybrid – Core onsite days Tuesday & Thursday; third onsite day flexible) · Duration: 12-month contract · Pay Rate: $45–$50/hour or about $102,000 a year · Only accepting local candidates · Position Overview · This role sup ...

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Sr. Technical Specialist – Regulatory Affairs & Global Certifications · The Sr. Technical Specialist – Regulatory Affairs & Global Certifications will manage key regulatory certification and compliance requirements for the Karma family of vehicles. Specifically, we seek a stron ...

Job Title: Regulatory Affairs Specialist IIJob Description · A Regulatory Affairs Specialist II plays a pivotal role in ensuring that the company's medical devices comply with regulatory requirements throughout their lifecycle. This mid-level position involves a blend of strategi ...

Sr. Regulatory Affairs Operations Specialist · Salary Range: $91,628 - $120,263 · (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, busin ...

This role supports the European Union In Vitro Diagnostic Regulation (IVDR) transition activities impacting all Bio-Rad products currently CE-marked under the IVD Directive. · Support IVDR transition projects by revising assigned technical files using the latest approved template ...

The job description is for a Sr. Specialist, Regulatory Affairs position at MicroVention. The role involves preparing strategy for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requireme ...

Sr. Regulatory Affairs Operations Specialist · Salary Range: $91,628 - $120,263 · (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, busin ...