Regulatory Affairs Specialist - Irvine

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 ...

The Regulatory Affairs Specialist will provide support to the Director of Regulatory Affairs in relation to the Company's regulatory compliance efforts. · Assist in managing regulatory affairs matters for the company · Responsible for supporting registration/regulatory needs to m ...

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. · ...

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 ...

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 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 ...

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 ...

We are looking for a highly motivated Medical Affairs Clinical Specialist to be part of our Medical Affairs team in Johnson & Johnson MedTech - Neurovascular. · This role provides medical oversight, clinical direction and scientific expertise throughout study design, execution an ...

+This position requires support for US and EU regulatory submissions. · +Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology) · 7+ years of experience Regulatory Affairs required · +ResponsibilitiesSupport US and EU regulatory submissions (exerc ...

· Overview · 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 ...

Additional Location(s):US-CA-Irvine · Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance · At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, ta ...

We are looking for a highly motivated Medical Affairs Clinical Specialist to be part of our Medical Affairs team in Johnson & Johnson MedTech – Neurovascular. · ...

· We're partnering with a growing medical device company to hire a Senior Regulatory Specialist. · Please see job description for more details. · ...

· Overview · Join our mission-driven Regulatory Affairs team as the Sr. Regulatory Affairs Specialist at Endologix · WHO WE ARE: · Endologix LLC is a California-based global medical device company dedicated to improving patients' lives through innovative therapies for the interv ...

The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases. · The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product developme ...

This Senior Regulatory Affairs Specialist role supports the regulatory strategy and lifecycle management for Class II devices at a commercial-stage medical device company. The position involves hands-on experience with FDA submissions and collaboration across cross-functional tea ...

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 looking for a highly motivated Medical Affairs Clinical Specialist to be part of our Medical Affairs team in Johnson & Johnson MedTech - Neurovascular. · ++Serve as the primary study medical lead for company sponsored clinical studies. · +Support the clinical trial team t ...

Kelly Science and Clinical FSP is currently seeking a Senior Regulatory Affairs Specialist for a long-term engagement in the US with one of our Global Medical Device clients in Irvine, California. This position is hybrid, on site Monday and Wednesday. This person will join our Ke ...

· Description · Position at Prismatik · Essential Functions: · Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. · Maintains company registrations and device listings in the US, Canada, and the EU. · Analyzes and reports d ...