227 regulatory affairs specialist jobs found

Job Description Requisition ID:6194 Job Title:Regulatory Affairs Specialist (Hybrid) Job Country:United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the...

Requisition ID: 32482 At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours....

Requisition ID: 32482 At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours....

Straumann Group Position Title: Regulatory Affairs Specialist Location/s: Fremont (CA), United States Job Category: Quality Assurance Company: BMUS - Bay Materials LLC Description: #ChangeMakers Ready to make an impact? We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude. #WeChangeDentistry every day. Be part of it. Summary of...

A Charlotte, NC based Medical company is searching for a Regulatory Affairs Specialist as they continue to grow. This Jobot Job is hosted by: Chris Smouse Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $80,000 - $120,000 per year A bit about us: A Charlotte, NC area based Medical company is searching for a Regulatory Affairs Specialist as they continue to grow. This role is based in Fort Mill, South Carolina and is the result of continued success, and sustained growth. The chosen applicant will collaborate with cross functional teams participating in projects to maintain and improve the Regulatory processes according to their internal Quality Systems and ensuring compliance with North America (USA and Canada) regulatory requirements. Some travel may be required. Why join us? What We Offer: Competitive base salary and overall compensation package Full benefits: Medical, Dental, Vision Generous PTO, vacation, sick,...

Overview Werfen 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) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Job Summary The Principal Regulatory Specialist...

Overview Werfen 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) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Job Summary The Principal Regulatory Specialist...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description We are currently seeking a Regulatory Affairs (RA) Specialist to join Biosciences Division Regulatory Affairs Team . As a member of the RA team, you will be planning, managing, and tracking of regulatory CMC submissions and regulatory documentation, including Drug Master Files for raw, ancillary, and starting materials used in the manufacturing of cell and gene therapies. Key responsibilities: Support of activities at Thermo Fisher Scientific site(s) located in Norway for the bead-based technology products and processes (part time). Serving as the liaison between Research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal. Collecting, consolidating and ensuring accuracy of documentation required for regulatory support in target markets (EU, US, and other global markets). Creating and maintaining up to...

Foundation Medicine, Inc. Full Time About the Job The Senior Specialist, Regulatory Affairs performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to health authorities such as FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document packages for regulatory agencies and ensures compliance with all requirements. Key Responsibilities Represent the regulatory affairs function on assigned cross-functional project teams. Assist in activities associated with regulatory approval of in vitro companion diagnostic medical devices in the US market. Write, prepare, edit and review regulatory submissions to expand indications of currently marketed products; documents include, but are not limited to: Significant Risk Determination Requests (SRDs); IDE applications; Pre-market applications (PMAs, sPMAs); and,...

Foundation Medicine, Inc. Full Time About the Job The Senior Specialist, Regulatory Affairs performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to health authorities such as FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document packages for regulatory agencies and ensures compliance with all requirements. Key Responsibilities Represent the regulatory affairs function on assigned cross-functional project teams. Assist in activities associated with regulatory approval of in vitro companion diagnostic medical devices in the US market. Write, prepare, edit and review regulatory submissions to expand indications of currently marketed products; documents include, but are not limited to: Significant Risk Determination Requests (SRDs); IDE applications; Pre-market applications (PMAs, sPMAs); and,...

Description Federal Regulatory Affairs Coordinator - Swedish First Hill (Full Time, Day Shift) Seattle, WA Swedish is seeking a full-time Federal Regulatory Affairs Coordinator - Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research. This includes preparation of all submissions to the IRB to assure the protection of human subjects in research; FDA-required submissions which may include investigator 1572 forms, investigational new drug applications, device submissions such as Emergency use, HDE, Safety Reports, and other documents that may be required by a regulatory agency or the institution. Leads the work of Research Assistants on a task-basis if applicable. Provides on-the-job training, sets priorities and schedules workflow required to support project objectives. Applicants must have:...

Job Summary This position is responsible for providing a superior level of customer support to customers and clients; answering inquiries regarding technical product information to ensure a smooth and positive experience. As part of the Technical Information Services department, this position will work with the global quality organization and regulatory teams to ensure that the information needed by our customers exists and will manage data needs as necessary to fill gaps. This position will have responsibility for ensuring that all information requests are completed according to defined service levels. The scope of the job is global, supporting one or more product lines, for the Functional Ingredients market segments. Bachelors degree in chemistry, biology or any related science required, masters preferred 3-5 years experience food regulatory experience required Complete customer and internal technical information (documentation) requests according to...