Regulatory Affairs Manager jobs in Plymouth, MA

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (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 Manager III
  • eTeam
  • Raynham, MA FULL_TIME
  • Company DescriptioneTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jer...
  • 1 Month Ago

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Temp to Perm - Remote Opportunity - Regulatory Affairs Manager
  • 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
  • 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 ...
  • 15 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 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...
  • 9 Days Ago

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0 Regulatory Affairs Manager jobs found in Plymouth, MA area

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Clinical Research Associate/Coordinator--Cancer Center Protocol Office
  • Partners Healthcare System
  • Boston, MA
  • GENERAL SUMMARY/ OVERVIEW STATEMENT: The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals...
  • 4/19/2024 12:00:00 AM

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Payments Transformation Analyst, Senior Associate
  • State Street Corporation
  • Quincy, MA
  • Global Delivery Custody is forming a central support team for the Payments, Cash, and Custody ("PCC") strategic developm...
  • 4/19/2024 12:00:00 AM

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VIP Remote Travel Consultant Servicing Executive Travelers for A Dedicated AccontE
  • American Express Global Business Travel
  • Boston, MA
  • Amex GBT is a place where colleagues find inspiration in travel as a force for good and through their work can make an i...
  • 4/19/2024 12:00:00 AM

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Director/Senior Director, Global Regulatory Affairs
  • Corbus Pharmaceuticals
  • Norwood, MA
  • As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus’ drug development by developing and ...
  • 4/19/2024 12:00:00 AM

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Quality Assurance Manager
  • Lancaster Colony Corporation
  • Wareham, MA
  • About Us T. Marzetti Company, a wholly owned subsidiary of Lancaster Colony Corporation (NASDAQ: LANC), is a manufacture...
  • 4/18/2024 12:00:00 AM

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Clinical Research Coordinator/Regulatory Assistant, Cancer Care
  • Boston Medical Center
  • Boston, MA
  • Position: Clinical Research Coordinator/Regulatory Assistant Location: Boston, MA Schedule: 40 hours per week ABOUT BMC:...
  • 4/18/2024 12:00:00 AM

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Payments Transformation Analyst, Senior Associate
  • State Street Corporation
  • Quincy, MA
  • Job Description Who we are looking for Global Delivery Custody is forming a central support team for the Payments, Cash,...
  • 4/18/2024 12:00:00 AM

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Senior Data Analyst - Risk Adjustment
  • Point32Health
  • Canton, MA
  • Under the supervision of the Manager, Data and Reporting, this individual will be responsible for supporting critical da...
  • 4/15/2024 12:00:00 AM

The latitude of Plymouth is 41.95833 and its longitude is −70.66778. According to the United States Census Bureau, the town has a total area of 134.0 sq mi (347 km2), of which 96.5 sq mi (250 km2) is land, and 37.5 sq mi (97 km2) (28%) is water. With the largest land area of any municipality in Massachusetts, Plymouth consists of several neighborhoods and geographical sections. Larger localities in the town include Plymouth Center, North, West and South Plymouth, Manomet, Cedarville, and Saquish Neck. Plymouth makes up the entire western shore of Cape Cod Bay. It is bordered on land by Bourne ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$148,367 to $209,280
Plymouth, Massachusetts area prices
were up 1.6% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020