Regulatory Affairs Specialist jobs in Brockton, MA

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 ...
  • 19 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...
  • 7 Days Ago

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Regulatory Affairs Specialist III
  • 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...
  • 12 Days Ago

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Regulatory Affairs Specialist
  • 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 I...
  • 1 Month Ago

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Regulatory Affairs Specialist
  • Integrated Resources INC
  • Mansfield, MA FULL_TIME
  • Company DescriptionINTEGRATED RESOURCES STAFFING PVT LTDJob DescriptionJob title: Regulatory Affairs SpecialistLocation: Mansfield, MA Duration: 5 months (possibility of extension) ROLES& RESPONSIBILI...
  • 1 Month Ago

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0 Regulatory Affairs Specialist jobs found in Brockton, MA area

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Senior Regulatory Affairs Specialist
  • Instrumentation Laboratory Company
  • Bedford, MA
  • Responsible for China NMPA and Japan PMDA registration and renewal activities for IL-labeled products. Related duties in...
  • 4/23/2024 12:00:00 AM

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Principal Regulatory Affairs Specialist
  • Instrumentation Laboratory Company
  • Bedford, MA
  • Key Accountabilities (Digital Factory Products)Conceive of and Implement the Regulatory Strategy in collaboration with C...
  • 4/23/2024 12:00:00 AM

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Principal Regulatory Affairs Specialist- USA Remote
  • AngioDynamics, Inc.
  • Marlborough, MA
  • Performs full-range of regulatory functions required for Global product registrations, new product development, and inte...
  • 4/22/2024 12:00:00 AM

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Senior Managing Scientist (Pharmacoepidemiology)
  • Exponent Inc.
  • Natick, MA
  • About Exponent: Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of ex...
  • 4/22/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • Convatec Group PLC
  • Lexington, MA
  • Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologi...
  • 4/20/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • Biofourmis
  • Needham Heights, MA
  • Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects an...
  • 4/19/2024 12:00:00 AM

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QA/RA Specialist
  • Walker Cole International
  • Boston, MA
  • Walker Cole International is searching for a QA/RA Specialist to join a Global Medical Device business in Massachusetts,...
  • 4/19/2024 12:00:00 AM

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Associate Director/Director, Toxicology
  • Keros Therapeutics
  • Lexington, MA
  • Job Summary You will play a critical role in ensuring the safety and efficacy of our pharmaceutical biologics. You'll le...
  • 4/19/2024 12:00:00 AM

According to the United States Census Bureau, the city has a total area of 21.6 square miles (56 km2), of which 21.5 square miles (56 km2) is land and 0.1 square miles (0.26 km2) (0.56%) is water. Brockton is the 162nd largest city by land area in the Commonwealth, and the twelfth largest of the twenty-seven towns in Plymouth County. Brockton is bordered by Stoughton to the northwest, Avon to the north, Holbrook to the northeast, Abington to the northeast, Whitman and East Bridgewater to the southeast, West Bridgewater to the south, and Easton to the west. Brockton is approximately 25 miles s...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$82,942 to $111,155
Brockton, Massachusetts area prices
were up 1.6% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
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