Regulatory Affairs Specialist jobs in Massachusetts

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Regulatory Affairs Manager / Regulatory Affairs Specialist role
  • Collabera
  • Mansfield, MA FULL_TIME
  • Company DescriptionEstablished in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30 offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.Job DescriptionJob Title: Regulatory Affairs ManagerDuration: 06 months (Possibility to Hire)Required:•The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.•In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.•The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.•Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.Qualifications• Bachelor's degree required. Scientific or engineering field preferred.• 5 years of medical device regulatory affairs experience.• Must have authored 510(k) submissions• Must have knowledge of U.S. FDA regulations and standards• 3 years of experience interacting with FDA and/or other regulatory agencies• Experience with devices containing software is strongly preferred.• Solid understanding of manufacturing and change control, and an awareness of regulatory trendsAdditional InformationTo know more on this position or to schedule an interview, please contact;Himanshu Prajapat973-606-3290himanshu.prajapat[@]collabera.com
  • 1 Month Ago

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Holbrook, MA CONTRACTOR
  • Responsibilities: Partnering with Product Development and management to prepare and review 510(k) submissions Preparing final 510(k) submissions and obtaining required management approvals Submitting ...
  • 16 Days Ago

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Regulatory Affairs Specialist II
  • Organogenesis
  • Canton, MA FULL_TIME
  • We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empow...
  • 4 Days Ago

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Regulatory Affairs Specialist - Remote
  • Corning
  • Tewksbury, MA FULL_TIME
  • Date: Apr 11, 2024 Location: Tewksbury, MA, US, 01876 Kennebunk, ME, US, 04043 Durham, NC, US, 27712 Company: Corning Requisition Number: 63008 Corning is vital to progress – in the industries we help...
  • 6 Days Ago

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Regulatory Affairs Program Specialist
  • Zoll Medical Corporation
  • Chelmsford, MA FULL_TIME
  • Regulatory Affairs Program Specialist Location: Chelmsford, MA, United States of America Resuscitation At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide inn...
  • 7 Days Ago

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Senior Regulatory Affairs Specialist
  • Medtronic
  • Boston, MA FULL_TIME
  • SENIOR REGULATORY AFFAIRS SPECIALIST - Digital Technologies The Senior Regulatory Affairs Specialist will play a key role in launching new products and sustaining the current product portfolio. As a n...
  • 8 Days Ago

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Regulatory Affairs Specialist
  • DivIHN Integration Inc
  • Green Oaks, IL
  • DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, C...
  • 4/19/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • ProKatchers LLC
  • St Louis, MO
  • Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
  • 4/19/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Direct Recruiters, Inc.
  • Chicago, IL
  • Our client is a global leader in ink and laser marking/coding industrial equipment manufacturing. They are seeking a Reg...
  • 4/19/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Adecco Staffing, USA
  • San Diego, CA
  • Regulatory Affairs Specialist Full Time San Diego, CA, US Salary Range: $90,000.00 To 110,000.00 Annually Monday - Frida...
  • 4/19/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Coltene
  • Cuyahoga Falls, OH
  • About the Organization Coltene is a global leader in the development, manufacture and sale of consumables and small-size...
  • 4/19/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Morair Medtech, LLC
  • Seattle, WA
  • Morair Medtech, LLC is at the forefront of medical technology, specializing in endobronchial treatments for lung disease...
  • 4/18/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Lake Forest, IL
  • Regulatory Affairs Specialist – Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medi...
  • 4/16/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Spectraforce
  • North Chicago, IL
  • Job Title: Specialist Regulatory Affairs, Pacific Asia Location: North Chicago, IL 60064 Duration: 7+ Months Min pay rat...
  • 4/15/2024 12:00:00 AM

Massachusetts is the 7th-smallest state in the United States. It is located in the New England region of the northeastern United States and has an area of 10,555 square miles (27,340 km2), 25.7% of which is water. Several large bays distinctly shape its coast. Boston is the largest city, at the inmost point of Massachusetts Bay, and the mouth of the Charles River. Despite its small size, Massachusetts features numerous topographically distinctive regions. The large coastal plain of the Atlantic Ocean in the eastern section of the state contains Greater Boston, along with most of the state's po...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$82,638 to $110,748

Regulatory Affairs Specialist in Petaluma, CA
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019