Regulatory Affairs Specialist jobs in Edison, NJ

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
  • TEPHRA
  • Edison, NJ FULL_TIME
  • Description :

    The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory submissions. Assist in the creation of technical documentation (technical files and design dossiers) for Spine products that will meet the requirements of the new Medical Device Regulation (MDR) in the European Union.

    The requirement is for 3 Regulatory Affairs Specialist.

    Responsibilities :

    • Identify reference documents for technical documentation including, but not limited to design and risk documents, verification / validation documents, standards conformance, and labeling.
    • Identify and adhere to policies, procedures and work instructions which support technical documentation activities.
    • Provide support for Clinical Evaluation Reports including references to required documentation.
    • Align technical documentation according to OneMD technical documentation structure proposed by the MDR team.
    • Prepare technical documentation for submission to and reviewed by Notified Bodies, as required.
    • Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
    • Maintain information on worldwide regulatory requirements and the status of product registrations.
    • Be responsible for adherence to timelines and ensure milestones are achieved.
    • Report issues to the Customer and Our Client management to ensure appropriate closure.
    • Work with Our client teams at offshore and at other geographies.

    Qualifications :

    Experience Required :

    • Strong knowledge of EU Medical Device regulations and guidance documents as well as relevant standards.
    • Experience of Tech File and technical Documentation for submission to notified bodies
    • Ability to work with cross-functional team members including (but not limited to) R&D, Quality, Labelling, Sterility, Medical and Clinical.
    • Experience in working with PLM systems (i.e. Agile and Windchill)
    • Proficient with MS Office applications such as MS Word, Excel.
    • Excellent communication and inter-personal skills.
    • Ability to manage multiple tasks and be detail-oriented.
    • Knowledge of German is a plus

    Generic Managerial Skills :

    • Highly developed negotiation and influencing skills
    • Highly developed and proven written and oral communication skills
    • Organizational / planning skills
    • Strong analytical skills
    • Comfortable with using and facilitating a variety of problem solving methodologies
    • Mentors and develops junior staff within the Our client delivery organization
    • Willing to work with offshore teams in remote locations

    Education :

    Bachelor of Engineering (Mechanical, Biomedical preferred) or Bachelor of Science (Biology or Chemistry)

    3 hours ago
  • 22 Days Ago

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Regulatory Affairs Specialist II
  • Katalyst Healthcares & Life Sciences
  • Edison, NJ FULL_TIME
  • Responsibilities : This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U. S. and Europe, support of international product registra...
  • 3 Days Ago

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • South Plainfield, NJ FULL_TIME
  • Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have ...
  • 14 Days Ago

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Regulatory Affairs Consultant
  • Katalyst HealthCares and Life Sciences
  • Rahway, NJ FULL_TIME
  • Responsibilities : Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' re...
  • 21 Days Ago

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Coordinator, Regulatory Affairs
  • L'Oreal
  • Clark, NJ FULL_TIME
  • Title: Regulatory Coordinator I, Safety Data Sheet (SDS) Author / Hazard Communication Department: Legal - Regulatory Supervisor: VP, Regulatory Affairs FLSA Status: Non-Exempt Location: Clark, NJ Com...
  • 2 Days Ago

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Regulatory Affairs Associate
  • Katalyst Healthcares & Life Sciences
  • South Plainfield, NJ FULL_TIME
  • Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have ...
  • 14 Days Ago

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0 Regulatory Affairs Specialist jobs found in Edison, NJ area

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CMC Regulatory Affairs Specialist
  • Spectraforce Technologies Inc
  • Bridgewater, NJ
  • Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shif...
  • 3/29/2024 12:00:00 AM

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Regulatory Affairs Specialist (Food & Beverage)
  • Symrise AG
  • Saddle Brook, NJ
  • The Regulatory Affairs Specialist (F&B) will be responsible to independently provide Symrise Inc. customers with product...
  • 3/28/2024 12:00:00 AM

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Senior Analytical Chemist – Drug Product Development
  • Exemplify Biopharma, Inc., a Symeres Company
  • Cranbury, NJ
  • Exemplify BioPharma, Inc. a Symeres Company is a global partner research organization (PRO) based in New Jersey, USA. We...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Icon Plc
  • New York, NY
  • At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and ...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Short Hills, NJ
  • Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validat...
  • 3/27/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • Bausch + Lomb
  • Bridgewater, NJ
  • Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of ...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Tephra
  • Edison, NJ
  • Description: The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory...
  • 3/26/2024 12:00:00 AM

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Program Support Specialist
  • Austincollege
  • Linden, NJ
  • 2 vacancies in the following locations: * Lenexa, KS * Queens, NY This Direct-Hire positions are in the Food and Drug Ad...
  • 3/25/2024 12:00:00 AM

According to the United States Census Bureau, the township had a total area of 30.638 square miles (79.351 km2), including 29.940 square miles (77.543 km2) of land and 0.698 square miles (1.808 km2) of water (2.28%). Edison is on the east side of Raritan Valley (a line of communities in central New Jersey), along with Plainfield, and completely surrounds the borough of Metuchen, New Jersey, making it part of 21 pairs of "doughnut towns" in the state, where one municipality entirely surrounds another. The township borders East Brunswick Township, Highland Park, New Brunswick, Piscataway Townshi...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$84,934 to $113,824
Edison, New Jersey area prices
were up 1.5% 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