Regulatory Affairs Specialist jobs in Portsmouth, NH

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 Specialist
  • Laborie Medical Technologies Corp
  • Portsmouth, NH FULL_TIME
  • We believe that great healthcare is an essential safeguard of human dignity.
    At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
    We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
    Who We’re Looking For:
    Laborie Medical Technologies is currently searching for a Regulatory Affairs Specialist to join our team in the Portsmouth, NH office. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific Laborie Medical products and ensures compliance with required regulations and established corporate standards.

    How you contribute:
    • Preparing documentation for international regulatory registrations and renewals
    • Defining worldwide regulatory requirements necessary for regulatory approval of assigned products
    • Executing product submission strategies as directed
    • Maintaining all regulatory documentation to ensure availability for external audits and preparation of submission packages
    • Maintaining a thorough knowledge of current regulatory requirements
    • Executing on additional responsibilities as defined by management

    Qualifications:
    • Bachelor’s Degree in Science, Engineering, or other relevant discipline
    • 1-3 years’ experience in Regulatory Affairs in the medical device industry
    • 1-3 years’ experience in international registrations
    • Working knowledge of quality system regulations and guidelines
    • Great communication skills with all levels of personnel
    • High level of organization and planning skills
    • Working knowledge of medical devices, procedures, and terminology

    Why Laborie:
    Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
    • Paid time off and paid volunteer time
    • Medical, Dental, Vision and Flexible Spending Account
    • Health Savings Account with Company Funded Contributions
    • 401k Retirement Plan with Company Match
    • Parental Leave and Adoption Services
    • Health and Wellness Programs and Events


    Laborie
    provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.

  • 23 Days Ago

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Manager Regulatory Affairs
  • Laborie Medical Technologies Corp
  • Portsmouth, NH FULL_TIME
  • We believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready ...
  • 22 Days Ago

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Regulatory specialist
  • Unitil Service Corporation
  • Hampton, NH FULL_TIME
  • Our CompanyMore than a utility company, Unitil provides energy for life.Our work helps keep homes comfortable, businesses thriving and communities connected. Unitil is an investor-owned public utility...
  • 2 Months Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Portsmouth, NH FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

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Maintenance specialist
  • East Coast Cannabis
  • Exeter, NH FULL_TIME
  • East Coast Cannabis is looking for a trustworthy, knowledgeable, and experienced Maintenance Technician to join our ECC team. This position is responsible for assisting in the maintenance and upkeep o...
  • 18 Days Ago

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Theater specialist
  • Best Buy
  • Newington, NH FULL_TIME
  • As an LG Home Theater Expert, you’ll work in one of our retail stores to promote, demonstrate and sell home theater products with an emphasis on the LG brand. First, we’ll give you all the training yo...
  • 18 Days Ago

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0 Regulatory Affairs Specialist jobs found in Portsmouth, NH area

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Remote Regulatory Compliance Analyst (Insurance Industry)
  • National General Insurance
  • Concord, NH
  • Job Description Position/Title: Remote Regulatory Compliance Analyst (Insurance Industry) ** NOTES: Ideal candidate will...
  • 3/28/2024 12:00:00 AM

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Validation Engineer III
  • Net2Source
  • Portsmouth, NH
  • Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Regi...
  • 3/28/2024 12:00:00 AM

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Wound Care Coordinator - RN
  • Genesis Healthcare
  • Hampton, NH
  • Oceanside Center seeks a full time Wound Care Coordinator! Benefits*Health, Dental, Vision, Company-paid life insurance,...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Atrium Medical
  • Hudson, NH
  • Position Specific Requirements: Responsible for internal, domestic, and international compliance activities working unde...
  • 3/27/2024 12:00:00 AM

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Financial Advisor
  • KMA Human Resources Consulting
  • Bedford, NH
  • Financial Advisor Robbins Farley, LLC Bedford, NH We are working with our client, Robbins Farley, LLC, in seeking a Fina...
  • 3/25/2024 12:00:00 AM

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Financial Advisor
  • KMA Human Resources Consulting
  • Bedford, NH
  • Job Description Job Description Financial Advisor Robbins Farley, LLC Bedford, NH Robbins Farley, LLC is seeking a Finan...
  • 3/24/2024 12:00:00 AM

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Controller
  • ConvenientMD
  • Portsmouth, NH
  • Who We Are At ConvenientMD, we're on a mission to make good health more convenient for all - working to improve how pati...
  • 3/24/2024 12:00:00 AM

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Systems Administrator
  • TEEMA
  • York Village, ME
  • Job Description Job Description System Administrator Description The System Administrator’s role is to manage and tune i...
  • 3/24/2024 12:00:00 AM

Portsmouth is a city in Rockingham County, New Hampshire, United States. As of the 2010 census it had a population of 21,233, and in 2017 the estimated population was 21,796. A historic seaport and popular summer tourist destination on the Piscataqua River bordering the state of Maine, Portsmouth was formerly the home of the Strategic Air Command's Pease Air Force Base, since converted to Portsmouth International Airport at Pease. According to the United States Census Bureau, the city has a total area of 16.8 square miles (43.6 km2), of which 15.6 square miles (40.5 km2) is land and 1.2 square...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$78,046 to $104,592
Portsmouth, New Hampshire area prices
were up 1.4% 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