Regulatory Affairs Specialist Jobs

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Job Title: Global Director, Regulatory Affairs For a detailed job description including salary information, please reference Job Number 2404, on http://www.coyotesourcing.com/board.html . EDUCATIONAL REQUIREMENTS: BA/BS or MS degree in Life Sciences, Engineering, or health care-related discipline EXPERIENCE: Ten or more years of experience in the medical device industry, some preferably in a ...

Clinical/Regulatory- Regulatory Affairs Associate Description The primary responsibility of the Regulatory Affairs Specialist will be to create and maintain Company Core Data Sheets (CCDS) for their assigned therapeutic area. Other duties include: Assist in life cycle management of labeling globally Lead cross-functional teams while providing strategic regulatory advice as it relates to labeli...

This would be a great position for someone will experience in Regularity Affairs who is passionate about working with medical products in a great work environment. Primary Roles and Responsibilities: Interact with FDA on regulatory submissions (including 510k) to gain clearance Work alongside global regulatory team developing clinical study and validation protocols with FDA compliance Review a...

We have been engaged by a privately held growing medical device manufacturer located in St. Louis, MO. Due to their significant growth, they have created two new positions within the Quality & Regulatory department. If you are an action oriented person with strong communication skills and enjoy working in a manufacturing facility then please continue reading. POSITION SUMMARY: The Manager of Qua...

CyberCoders Matching Great People with Great Companies Learn more about CyberCoders Regulatory Affairs Specialist Sharon, MA Full-Time $60,000 - $80,000 Apply Apply Regulatory Affairs Specialist Sharon, MA Full-Time $60,000 - $80,000 Apply Job Details We are a commercial leader in regenerative medicine based just outside of Boston with easy access from the 93, 95 and 24! As the Regula...

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...

REGULATORY AFFAIRS SPECIALIST – MEDICAL DEVICE The Regulatory Affairs Specialist will be centrally located in Massachusetts (30 minutes north of Boston) Are you interested in leveraging your career? If so, then our client is looking for candidates with the following skills: 4 years working within Regulatory Affairs within Med Device industry BS degree Previous experience compiling, preparing...

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...

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...

Kelly Clinical Research has an exciting opportunity for a Post-Market Senior Regulatory Affairs Specialist. This is a contract role in Mansfield, MA at a leading medical device company. SUMMARY OF POSITION: Primary responsibility is for leading and managing the post-market field activities of medical device products and processes and to coordinate across the global business the customer notifica...

The Regulatory Affairs 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 (IVD's) as well as maintenance of existing IVD's. Will assist in coordination, preparation and submission of regulatory documents, ensuring compliance with FDA and ISO requirements as well as other requ...

Life-changers work here At CareFusion, we create innovative ways to help our customers improve patient care. We rely on bold and inspired employees who share our commitment to helping solve some of healthcare's most critical challenges. CareFusion is now part of Becton Dickinson, a global medical technology company focused on addressing many of the world's most pressing and evolving health needs...

Company: Quaker Chemical JOB SUMMARY: Thisrole is responsible for leading compliance and managing efforts related toTSCA, PMN preparation, NOC submittals and DSL/NDSL compliance. Also ensure thatadditional regulatory practices are in line with local, state,& federallaws. Supports the Safety, Health & Environmental team and other Quakerassociates with other environmental and safety concerns. LOCA...

Sr. Regulatory Affairs Specialist Plymouth, MN Kelly Services is currently seeking a Sr. Regulatory Affairs Specialist for one of our top clients in Plymouth, MN. This is a direct hire opportunity. As a Sr. Regulatory Affairs Specialist placed though Kelly Services, you will provide regulatory expertise for the company site based in Plymouth, Minnesota. The incumbent will also be required to pro...

Regulatory Affairs Specialist Kelly Scientific is seeking a Regulatory Affairs Specialist for an immediate need in the West Chester PA area. In this role, we are seeking a self-starter that has a strong knowledge of Regulatory guidelines. The incumbent will support international filings. This is a long term contract (6-9+ months). BS/BA in a Life science or related discipline. Understanding is ...

Responsible for the assembly, quality control and dissemination of data and documentation to regulatory agencies and technical areas. 1. Responsible for formatting, compiling, and electronic filing of regulatory submissions 2. Provides Electronic Document Publishing support (i.e., scanning, rendering, bookmarking/hyperlinking and verification) and compiles Modules 1-5 in eCTD format, Paper or Ne...

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...

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...

I. PURPOSE AND SCOPE The Regulatory Affairs Specialist is responsible for maintaining accurate and current data concerning Tender finished goods on governmental and non-governmental databases. The Specialist will facilitate confident reliance on Tender’s institutional knowledge and data. The Specialist will standardize, document, and maintain accessible data. External regulatory agencies, customs...

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...