Top Regulatory Affairs Executive jobs in Plymouth, MA

Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes 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, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (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 ...
  • 21 Days Ago

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Regulatory Affairs Intern
  • Organogenesis
  • Canton, MA INTERN
  • About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to g...
  • Just Posted

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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...
  • 9 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...
  • 14 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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0 Top Regulatory Affairs Executive jobs found in Plymouth, MA area

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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,...
  • 4/24/2024 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...
  • 4/24/2024 12:00:00 AM

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RN or LPN, Staff Nurse **DAY & NIGHT SHIFTS AVAILABLE**
  • Bay Path Rehab & Nursing Center
  • Plymouth, MA
  • Bay Path Rehab & Nursing Center - 7AM-3PM and 11PM-7AM Full Time/Part Time/Per Diem Availability!!! RN SALARY RANGE: $34...
  • 4/24/2024 12:00:00 AM

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Senior R&D Project Manager
  • Philips
  • Plymouth, MA
  • Job Title Senior R&D Project Manager Job Description Cross-functional Core Team Leader responsible for the development a...
  • 4/24/2024 12:00:00 AM

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RN, Per Diem - PACU
  • Beth Israel Lahey Health
  • Plymouth, MA
  • **When you join the growing BILH team, you're not just taking a job, youre making a difference in peoples lives.** **Job...
  • 4/23/2024 12:00:00 AM

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Biomedical Equipment Support Specialist (Imaging)
  • U.S. Food and Drug Administration
  • Brockton, MA
  • ** Biomedical Equipment Support Specialist (Imaging)** **Department of Veterans Affairs** ** VA Boston Healthcare System...
  • 4/21/2024 12:00:00 AM

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Delivery Driver
  • Bud's Goods + Provisions
  • Lakeville, MA
  • Summary Bud's Goods & Services is seeking a dedicated and legally astute Delivery Driver who will focus on the transport...
  • 4/21/2024 12:00:00 AM

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Inventory Manager
  • cannapidispensary.com
  • Brockton, MA
  • **job description** We are seeking an Inventory Manager who will provide day-to-day inventory management and carry out v...
  • 4/21/2024 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 Top Regulatory Affairs Executive jobs
$315,474 to $516,123
Plymouth, Massachusetts area prices
were up 1.6% from a year ago

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