Project Manager, Regulatory Affairs - Irvine

· We are searching for a Director of Regulatory Affairs with deep expertise in invasive electromechanical medical devices and extensive experience preparing and submitting 510(k) notifications. · Leads the preparation, submission, and negotiation of 510(k) premarket notification ...

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 ...

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel ...

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 ...

We are searching for a Director of Regulatory Affairs with deep expertise in invasive electromechanical medical devices and extensive experience preparing and submitting · 510(k) notifications. This individual will lead regulatory strategy and submissions for · devices requiring ...

+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 ...

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

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 ...

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Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel ...

We are seeking a Regulatory Affairs Manager to develop and execute global regulatory strategies for new and existing 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 ...

· Company Description · About Collabera · Collabera is the largest minority-owned Information Technology (IT) staffing firm in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 10,000 professionals across North America (U. ...

Description · Job Title: Project Manager, Regulatory Affairs · Supervisor/Manager Title: Senior Manager, Regulatory Affairs · Job Description Summary: Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clini ...

· 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 ...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in ...

· 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 ...

We are seeking a Senior Manager of Regulatory Affairs to lead regulatory strategy and execution for Class III cardiovascular medical devices. The ideal candidate has deep experience with PMA submissions, EU MDR requirements, and post-market activities within high-risk implantable ...

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 ...