Sr. Regulatory Affairs Specialist - Irvine, CA

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 ...

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. · ...

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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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 ...

+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 ...

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 ...

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 ...

· 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 employee ...

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

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. · ...

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 ...

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. · ...

Sr. Regulatory Affairs Specialist responsible for providing strategic input and technical guidance on product lifecycle planning and regulatory requirements. · ...

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 ...

Job Description · Duties and Responsibilities · Support international filings/registrations · Coordinate with international regulatory team members on product changes · Maintain product list on Certificate of Foreign Government · Coordinate with Customer Support/Shipping product ...

· 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 ...