Regulatory Affairs Specialist Jobs

1000+ jobs

Duties: - Compile and maintain regulatory documentation. - Coordinate preparation of regulatory documents/submissions for domestic or international projects. - Communicate with product development/engineering regarding pre-submission strategies, potential regulatory pathways, and compliance test requirements. - Interpret regulatory rules/rule changes and communicate to internal parties. - Re...

Quality Assurance and Regulatory Affairs (QA/RA) Specialist Job Label:SYN-QARS Would you like to take your quality experience and documentation skills to the next level? You can, by putting your quality and regulatory experience where they are truly needed –with Synergy Health, a strong, growing company in the midst of the vibrant healthcare industry. Your knowledge of quality and current FDA re...

Experis is seeking a highly motivated individual for a period of period of 6 months to assist with regulatory submission of the company's products. The successful candidate will be responsible for assisting the Regulatory Affairs Manger in filing necessary applications for state product registration. This individual will be responsible for working on ensuring documentation is archived, tracking st...

Job Title: Regulatory AffairsSpecialist Reports To: Director of Regulatory Affairs& Quality Assurance Department: Regulatory and Quality Assurance Direct Reports:0 Location: Danvers, MA FLSA Status: Exempt EEO-1:Professionals Prepared By/Date: Human Resources June 2015 SUMMARY: Responsible for provide technical assistance in all regulatory functions of a Class II medical device company tha...

Job Description: Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems st...

WHO WE ARE Bio-Techne includes the complementary brands, R&D Systems, Novus Biologicals, Tocris, ProteinSimple, and BiosPacific. We have brought these brands together as Bio-Techne to be a stronger scientific partner to help customers attain their research goals.Watch our story and learn more about Bio-Techne here: http://www.bio-techne.com/our-story POSITION SUMMARY The Senior Quality Assuranc...

The moment you see that your work makes doctors' lives easier and patients' lives better. This is the moment we work for. // MEDICAL TECHNOLOGY MADE BY ZEISS Would you like to be part of a dynamic organization who enable health care professionals to improve the lives of their patients in ophthalmology, microsurgery and other medical growth sectors? The Senior Regulatory Affairs Specialist is ...

Are you looking for a new opportunity, a chance to get in at the Ground Level, with a Medical Device Start Up? Look no further! My client is a Medical Device start up in the Minneapolis area, and they are looking for a Regulatory Affairs Specialist! This is a part time position. It is a contract to hire position. Among others, the Regulatory Affairs Specialist will have the following responsibili...

About the Company TeraRecon is the largest independent provider and a global leader in advanced image processing innovation for CT, MR and PET, advanced imaging-based decision support and 3D visualization techniques. An eight-time winner of Frost and Sullivan awards, the company has developed a leading portfolio of products and technologies that advance the performance, quality, functionality, an...

Senior Regulatory Affairs Specialist CD Diagnostics combines expertise in immunoassay development with biomarker research, patented technology, and cGMP manufacturing to deliver a range of products that address challenging diagnostic issues. We are improving patient outcomes by providing more accurate and rapid diagnosis. Position: The Senior RA Specialist will be to develop and sustain projects...

Description: PPD is recruiting forRegulatory Affairs Specialists. In this role you will provide regulatory advice and carry out projects in the provision of regulatory affairs services. You will also act as liaison with internal and external clients in the provision and marketing of regulatory affairs services. Responsibilities include but are not limited to: Performing the day to day operatio...

Overview: The position of Regulatory Affairs Specialist / Sr. Regulatory Affairs Specialist will be responsible to provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in both the U.S. and global regions. Provide regulatory support to marketed products and ensure company’s regulatory compliance status. Essenti...

Manager, Regulatory Affairs Job Label:AI_MRA2 Position Summary The Regulatory Affairs Manager is responsible for providing regulatory support and guidance to project teams and regulatory staff and preparing and submitting FDA and European submissions for approval. Manage process from development of regulatory strategies thru to approval. Ensure compliance with all U.S. and international regulat...

YOU MUST CURRENTLY WORK WITH REGULATORY AFFAIRS WITHIN THE MEDICAL DEVICE MARKET Leading manufacturer of medical devices is seeking a Regulatory Affairs Specialist to work with FDA and Internal Department to assure quality control for company products. You must be located in the Minneapolis Minnesota MN area. Requirements: *2-5 years experience in regulatory affairs on medical devices *Must h...

School Regulatory Affairs Specialist: F/T; Assist Academic Officer/DSO in researching & interpreting regulatory rules and ensure that they are communicated through school policies and procedures; Req. Bachelor's degree in Legal Studies or related; Mail resume to Bethesda University(Attn: HR Officer), 730 N. Euclid St. Anaheim, CA 92801. www.ocjobfinder.com/monster...

Position Summary: Responsible for preparation of regulatory submissions required to market new or modified in-vitro diagnostic devices in both domestic and international markets including all relevant maintenance activities. Major Responsibilities: Acts as a core member on development teams to provide regulatory guidance, and develop regulatory strategies and timelines. Prepares documents nece...

Regulatory Affairs Specialist 2 - 150916 Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical a...

Senior Regulatory Affairs Specialist - 140520 Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgi...

The Regulatory Affairs Import Specialist will develop, monitor and implement strategies, work plans, and policies to ensure regulatory compliance with federal regulatory agencies. The Specialist is also responsible for facilitating the regulatory compliance and clearance of import and export goods. Develop, implement and monitor compliance plans based on federal regulations Create and manage ent...

With our strong investment in research and development, and culture of continuous improvement, Hexcel is the industry leader in the manufacturing of industrial fabrics and composite materials. Over 5,000 people work for Hexcel at various manufacturing sites, sales offices and R&T centers around the globe……we call them our “Strength Within". The job holder will provide Regulatory Affairs/Product S...