Regulatory Affairs Specialist Jobs

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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. .. Prepare and su...

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. Summary...

Clinical/Regulatory - Regulatory Affairs Ops Specialist Description This section focuses on the main purpose of the job in one to four sentences. Under limited supervision responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions. Produces and evaluates technical and scientific data necessary for regulatory...

Overview: Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our u...

We are the maker, marketer and distributor of branded food products that have been American favorites for decades. Our employees located in more than 20 offices and plants across North America rally around our mission, Reinvigorating Iconic Brands. We work to transform our brands to be more profitable for our customers and more enjoyable for our consumers. At Pinnacle Foods, every employee has th...

Would you like to join a leading global manufacturer of flavors and fragrances? Every day, Kelly Scientific Resources connects scientific professionals with opportunities to advance their careers, and we currently have a temporary-to-hire opening for a Regulatory Affairs Specialist in Schaumburg, IL. The Regulatory Affairs Specialist, Flavors Group will assure compliance of products with appropr...

Sr Regulatory Affairs Specialist Responsible for Internal, Domestic and International compliance activities. Job Functions: (Primary “essential” duties and responsibilities) · Participates as a member of a cross-functional product development team. · Prepares Regulatory strategy/plans and requirements. · Prepares worldwide regulatory submissions/registrations. · Participates in the review an...

Regulatory Affairs Specialist My client is seeking Regulatory Affairs Specialists experienced in the Biotechnology and Pharmaceutical industries. They have multiple openings and are open to seeing resources with varying levels of experience. Core Skills: * Excellent communication skills - verbal, writing, presentations * Strong analytical and problem solving skills - ability to work in a struc...

Responsible for preparing and reviewing technical documents, labeling and FDA forms for submission. Including 510(k) submissions, licensing, HHE recall and MDR. Support Supply Chain initiatives around product classification for regulatory bodies to ensure import compliance. Responsible for the coordination and reporting of Quality Metrics to include Nonconformance, RMAs, and other systems identi...

This position will be responsible for all CMC regulatory activities, including preparation, coordination and review of INDs, NDAs, ANDAs, DMFs, MAFs, VMFs, and any other regulatory submissions. It has the responsibility to ensure that current GMP and CMC regulatory guidance and trends are communicated to the site management. This position requires appropriate CMC expertise such that they can provi...

Job Title:-Regulatory affairs Specialist Location:- Waukesha , WI Job Description:- Skills & Experience Required:- • Identification of the assigned and/or relevant medical device data values via existing 510(k) records – 20% • Compiling all the information pertaining to the medical device attributes for existing 510(k) legacy and NPI products– 10% • Completing and recording the UDI attribute...

The Regulatory Affairs (RA) Specialist’s primary responsibilities are to support a broad range of regulatory functions at BioFire Defense, particularly those relevant support of new in vitro diagnostics (IVDs) as well as to maintenance of existing IVDs. The RA Specialist will assist in coordination and preparation of regulatory submissions, ensuring compliance with FDA requirements as well as othe...

Seeking individual with experience interfacing directly with officials from the FDA Office of Prescription Drug Promotion (OPDP). Shall: *** Review advertising and marketing materials to ensure submission forms meet regulatory compliance criteria. *** Communicate with key decision makers in the Office of Prescription Drug Promotion. *** Review and approve all documents and forms including FDA ...

Southborough, MA - The International Regulatory Affairs Specialist, Asia will support international regulatory affairs activities, including but not limited to: assist in providing international regulatory expertise to new product development and sustaining engineering team's preparation and submission of regulatory documentation for product registration/licensing in Asia and selected global marke...

Southborough, MA - The International Regulatory Affairs Specialist, Japan will support international regulatory affairs activities, including but not limited to: assist in providing international regulatory expertise to new product development and sustaining engineering team's preparation and submission of regulatory documentation for product registration/licensing in Japan and other selected glob...

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...

A class II medical device client of ours is seeking to add a senior regulatory affairs specialist to their team via direct hire. The regulatory affairs senior specialist needs to have the following experience: At least 3+ years of experience in the medical device industry 510(K) clearance authorship experience (at least 1 510(K)) International regulatory affairs submissions experience is prefer...

Company Confidential
Are you missing out on the recognition you deserve at work? Would you enjoy working directly with key individuals within a company to help make a difference in the organization’s future? This is your chance to showcase your skills at the international level. Due to growth, our client is looking for aSenior Regulatory Affairs Specialist to join their team in Redmond, WA just outside of Seattle. In...

Company Confidential
Global Cosmetic Manufacturer located in Rockland County, NY is seeking a Regulatory Affairs Specialist. This position will provide direct World Wide Regulatory support to various projects and products; support strategic planning and product development efforts. Responsibilities: · Provide Regulatory support for existing products with respect to product changes/modifications, labeling and promoti...

TrueBridge Resources, a North Highland company, is #4 on Staffing Industry Analysts' 2014 list "Fastest-Growing U.S. Staffing Firms." We work with clients to fulfill Contract, Contract-to-Hire, and Direct Hire opportunities within Information Technology and Accounting/Finance. We're passionate about staffing! Let us show you. We are working with our direct client on a contracting position in Chan...