Regulatory Affairs Jobs in USA

Job Description Summary Senior Regulatory Affairs professional with 8 years of experience in medical devices specializing in US FDA EU MDR and APAC regulations. Proven track record in leading 510(k) PMA and EU Technical Documentation submissions managing audits and inspections and driving end-to-end...

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. This Client is mission is to discover and deliver innovative medicines and solutions that address complex health issues and enhan...

Role: R&D - Scientific & Regulatory Affairs (SRA) AssociateLocation: Hackettstown NJ 07840 or Newark NJ 07102Work Model: Hybrid (2-3 days onsite; typically Mon/Fri WFH)Type: 12-Month Contract Job Summary We are seeking a Scientific & Regulatory Affairs (SRA) Associate to support product quality con...

The Government Relations & Regulatory Affairs Director serves as a subject-matter expert on federal and state legislative and regulatory issues impacting Urban Indian Organizations (UIOs) Federally Qualified Health Centers (FQHCs) and Medicaid-funded health services. Working directly with the Chief...

What Youll DoAs a Regulatory & Environmental Compliance Specialist youll play a key role in ensuring our products facilities and operations comply with environmental health and safety requirements while helping the business move forward responsibly.You will:Ensure compliance with environmental healt...

The Trade Compliance Analyst Associate will support our compliance initiatives by monitoring import and export activities to ensure adherence to all applicable U.S. and non-U.S. laws and regulations. Involved in analyzing export classifications monitoring compliance risk and collaborating with cross...

Primary Responsibilities and Essential Job Functions:Drive improvements to the quality system that ensures its suitability adequacy and effectiveness.Understand and ensure compliance with cGMP ISO 13485 and FDA 21 CFR Part 820 regulations.Provide operational support related to issue resolution produ...

The Certification Quality Specialist II executes routine tasks and approvals to support product review and data management initiatives. They will work and maintain database software systems and can work with limited supervision to support process updates maintain data quality and execute verificatio...

Primary Function of Position:Intuitive Surgical designs and manufactures highly complex surgical systems including cameras instruments and accessories for use in surgery. We are looking for a proven quality functional leader to support the projects associated with the development of next generation...

Primary Function of Position:Intuitive designs and manufactures highly complex systems for use in robotic-assisted surgeryand minimally invasive lung biopsy. These systems employ a combination of reusable andsingle-use devices for each procedure. The primary function of the Quality Engineer is to ac...

The Role: The Director Government Affairs & Public Policy is a senior individual contributor responsible for leading the companys engagement with U.S. policymakers and regulators and as needed state and international policymakers and regulators on issues affecting the Company and Bitcoin and digital...

At PGE our work involves dreaming about planning for and realizing a smarter cleaner more enduring Oregon neighborhood. Its core to our DNA and we havent stopped since we started in 1888. We energize lives strengthen communities and drive advancements in energy that promote social economic and envir...

At PGE our work involves dreaming about planning for and realizing a smarter cleaner more enduring Oregon neighborhood. Its core to our DNA and we havent stopped since we started in 1888. We energize lives strengthen communities and drive advancements in energy that promote social economic and envir...

The NA WHS Regulatory Response and Activity Manager will be responsible for responding timely and accurately to environmental safety and health regulatory interactions. We are looking for someone who can contribute to the groups operational excellence by assisting with the execution of our complian...

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together we support innovation from concept to commercialization offering expertise in regulatory strategy clinical tria...

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together we support innovation from concept to commercialization offering expertise in regulatory strategy clinical tria...

IntroductionWerfen Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM...

CoreWeave is The Essential Cloud for AI. Built for pioneers by pioneers CoreWeave delivers a platform of technology tools and teams that enables innovators to build and scale AI with confidence. Trusted by leading AI labs startups and global enterprises CoreWeave combines superior infrastructure per...

Senior Director Quality Position Summary: 100% on-siteCatalents Kansas City facility is home to our Oral & Specialty Drug Delivery Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms from formulation deve...

Job DescriptionKickstart Your Career at Vertex!Are you ready to make a real impact At Vertex our mission is to tackle serious diseases and to change lives for the better for the future. Our aim is to give you the skills insights and career guidance to be an important part of that future; to turn you...