Regulatory Affairs Lead Jobs in USA

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company our goal is to tr...

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. At PROCEPT we put the patient first in everything we do andare committed to revolutionizing treatment for benign prostatic hyperplasia (BPH otherwise known...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially di...

Location: GaithersburgHybrid: 3 days a week onlineAt AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledge-sharing ambitious thinking and innovation ultimately providing employees with the opportunity to work across teams functions and even the globe.When we pu...

Position Details: Our client a world-leading Pharmaceutical Company in San Diego CA is currently looking for an Quality & Regulatory Affairs Lead to join their expanding team. Job Title: Quality & Regulatory Affairs Lead / Pharma Manufacturing / Hybrid Work Duration: 15 months contract extendable...

OverviewThis is a REMOTE position. The Regulatory Affairs Specialist 2 responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to speak read and write in business l...

Remitee is scaling its cross-border payments platform across key markets in LATAM/USA/EU. We are looking for a Head of Regulatory Affairs (Regional) with strong hands-on experience leading regulatory filings licensing applications implementation and ongoing maintenance for payment-related licenses (...

Roles & Responsibilities1. Implementation and continuous improvement of the Medical Device Quality2. Management Systems and associated CE requirements in order to meet customer3. and regulatory requirements 4. Preparation implementation and Maintenance of Manual policies work instructions as per ISO...

Roles & Responsibilities1. Implementation and continuous improvement of the Medical Device Quality2. Management Systems and associated CE requirements in order to meet customer3. and regulatory requirements 4. Preparation implementation and Maintenance of Manual policies work instructions as per ISO...

Make a meaningful difference to patients around the world. From design to production our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities and...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Compa...

Who we are About StripeStripe is a financial infrastructure platform for businesses. Millions of companies - from the worlds largest enterprises to the most ambitious startups - use Stripe to accept payments grow their revenue and accelerate new business opportunities. Our mission is to increase the...

Who we are About StripeStripe is a financial infrastructure platform for businesses. Millions of companies - from the worlds largest enterprises to the most ambitious startups - use Stripe to accept payments grow their revenue and accelerate new business opportunities. Our mission is to increase the...

Roles & Responsibilities1. Implementation and continuous improvement of the Medical Device Quality2. Management Systems and associated CE requirements in order to meet customer3. and regulatory requirements 4. Preparation implementation and Maintenance of Manual policies work instructions as per ISO...

Government & Regulatory Affairs - Trade Remedies Associate About the Role: As an Associate in the Trade Remedies group you will work on complex trade matters involving investigations administrative proceedings and litigation. The role offers significant hands-on experience and the opportunity...

Primary Function of PositionThe Senior Regulatory Affairs Specialist serves as the primary point of contact for regulatory strategy and execution of projects involving complex electromechanical software controlled robotic systems instruments and accessories SaMD and advanced imaging systems. The Sen...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Compa...

Job Summary:The Director of Regulatory Affairs is responsible for executing the companys regulatory strategy across the development and commercial product portfolio. This role reports to the Senior Vice President Regulatory Affairs. This individual serves as the regulatory affairs main contact to pr...

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...

What Were Looking ForThe Senior Regulatory Affairs Specialist will perform daily tasks under supervision and be responsible for coordinating and managing international shipments to ensure timely compliant and cost-effective importation and exportation of addition this role will adhere to procedures...