Sr. Regulatory Affairs Specialist - Irvine - Endologix

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 ...

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. · ...

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 ...

+Regulatory Affairs Specialist II with working knowledge of FDA, and CE marking requirements for IVD products. · +Support the IVDR project by revising assigned technical files. · Update labeling specifications to meet IVDR requirements. · ...

The Regulatory Affairs Specialist will support the Director of Regulatory Affairs in regulatory compliance efforts. · Strong understanding of regulatory requirements · Effective research and analytical skills · Strong verbal and written communication skills · ...

The Regulatory Affairs Specialist will provide support to the Director of Regulatory Affairs in relation to the Company's regulatory compliance efforts. This includes managing regulatory affairs matters for the company, ensuring compliance with regulatory requirements for Company ...

+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 ...

This is a Senior Regulatory Affairs Specialist position for a Medical Devices Company in Irvine, CA. The job involves planning and implementing regulatory submissions and interacting with the regulatory body to further product approvals or clearance. · ...

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 ...

· 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 ...

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 ...

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 ...

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. · Here, you'll be supported in progressing – whatever your ambitions. · ...

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 ...

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

Senior Regulatory Affairs Specialist is responsible for planning, coordinating and implementing regulatory Submissions for products that require government approval. · Demonstrates working knowledge of healthcare-related regulations · Demonstrates in-depth knowledge of preparing ...

Johnson & Johnson is recruiting for a Medical Affairs Clinical Specialist located in Irvine, California. · 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 provi ...

+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 ...

We re partnering with a growing medical device company to hire a Senior Regulatory Specialist to help drive FDA submissions and product approvals across a portfolio of Class II devices. · ...