Regulatory Affairs Specialist jobs in New Hampshire

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 II
  • Laborie
  • 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. 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.
    • 4 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

    Laborieprovides 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.
  • 10 Days Ago

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Senior Regulatory Affairs Specialist
  • Laborie
  • 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...
  • 13 Days Ago

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Regulatory Affairs Specialist II
  • 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...
  • 23 Days Ago

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Director, US Regulatory Affairs
  • Sequel Medical Technology
  • Manchester, NH FULL_TIME
  • About SequelSequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.Job OverviewReporting to the Vice President, Quality & Regulatory, the US Regula...
  • 18 Days Ago

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Regulatory Affairs Senior Associate (1042948)
  • The Judge Group
  • Newbury, NH CONTRACTOR
  • Location: Newbury Park, CA, USASalary: $30.00 USD Hourly - $37.00 USD HourlyDescription: Our client is currently seeking a Regulatory Affairs Senior AssociateDay to Day Responsibilities: Support the i...
  • 10 Days Ago

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Regulatory Affairs CMC Manager II
  • Lonza
  • Portsmouth, NH FULL_TIME
  • United States, Portsmouth (New Hampshire) Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our gr...
  • 23 Days Ago

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Santa Clara, CA
  • Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Experis
  • Maplewood, MN
  • Our client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Alphatec Spine
  • Carlsbad, CA
  • Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Astrix
  • Fort Worth, TX
  • Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Highridge Medical
  • Westminster, CO
  • Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
  • 6/9/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • CM Medical Recruitment
  • CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Net2Source Inc.
  • Palo Alto, CA
  • Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
  • 6/7/2024 12:00:00 AM

New Hampshire is part of the six-state New England region. It is bounded by Quebec, Canada, to the north and northwest; Maine and the Atlantic Ocean to the east; Massachusetts to the south; and Vermont to the west. New Hampshire's major regions are the Great North Woods, the White Mountains, the Lakes Region, the Seacoast, the Merrimack Valley, the Monadnock Region, and the Dartmouth-Lake Sunapee area. New Hampshire has the shortest ocean coastline of any U.S. coastal state, with a length of 18 miles (29 km), sometimes measured as only 13 miles (21 km). New Hampshire was home to the rock forma...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$77,643 to $104,051

Regulatory Affairs Specialist in Petaluma, CA
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
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019