Top Regulatory Affairs Executive jobs in Massachusetts

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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Sales Executive
  • Top Closers
  • Chelmsford, MA FULL_TIME
  • Are you looking for your next exciting career move in sales? Are you driven, self-motivated, and an excellent communicator? If the answer is YES, then look no further as this is the role for you! We h...
  • 16 Days Ago

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Executive Assistant to Secretary
  • EO of Energy and Env Affairs
  • Boston, MA FULL_TIME
  • Executive Assistant to Secretary The Executive Office of Energy and Environmental Affairs Secretariat (EOEEA) provides oversight of the Commonwealth’s energy and environmental agencies, namely, the Di...
  • 18 Days Ago

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Associate Director, Regulatory Affairs
  • Wave Life Sciences
  • Lexington, MA FULL_TIME
  • Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chem...
  • 12 Days Ago

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Director, Regulatory Affairs
  • Dyne Therapeutics
  • Waltham, MA FULL_TIME
  • Role Summary: The Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs. The person in this role must thrive wor...
  • 12 Days Ago

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VP, Regulatory Affairs & Quality
  • Vigil Neuroscience, Inc.
  • Watertown, MA FULL_TIME
  • Vigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, t...
  • 12 Days Ago

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Regulatory Affairs Expert
  • ProKatchers
  • St. Louis, MO
  • Job Description: · With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory t...
  • 4/17/2024 12:00:00 AM

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Sr. Regulatory Affairs Specialist
  • B. Braun Medical Inc. (US)
  • Bethlehem, PA
  • Responsibilities: Essential Duties Plans and prepares registration documents for marketing approval of drug and device p...
  • 4/17/2024 12:00:00 AM

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Regulatory Affairs Specialist (IVD)
  • Nelson Connects
  • Irvine, CA
  • Location: Irvine, CA Shift: 8am-5pm (hybrid) Type: 12 month assignment (Temporary) Industry: Life Science Pay Range: $40...
  • 4/17/2024 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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Principal Regulatory Affairs Specialist
  • Planet Pharma
  • Palo Alto, CA
  • Responsibilities and Duties: Acts as technical regulatory lead on core product development teams, communicates regulator...
  • 4/16/2024 12:00:00 AM

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Regulatory Affairs Officer
  • Brio Group
  • Job Title: Regulatory Affairs Officer Company: Biopharma Organization Location: Hybrid, RTP Area Brio Resource Group is ...
  • 4/15/2024 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

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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...
  • 4/14/2024 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 Top Regulatory Affairs Executive jobs
$318,696 to $521,395

Top Regulatory Affairs Executive in Wilmington, NC
On average, a Doctorate Degree is the highest level of education for a Top Regulatory Affairs Executive.
February 04, 2020
Top Regulatory Affairs Executive in Champaign, IL
If you were hiring a person for this job As Top Regulatory Affairs Executive, what would you look for.
February 06, 2020
Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020