Regulatory Affairs Specialist jobs in Elizabeth, 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)
Recently Added Regulatory Affairs Specialist jobs
Regulatory Affairs Specialist II
- Mitchell Martin
-
Secaucus, NJ
FULL_TIME
-
8/1/23 Nadine - We just spoke with the hiring manager, and he updated the role with the below notes.
Need to understand the process to commercialize and go to market with a new assay.
Understands the purpose of a design control.
Understand the process of going to a clinical trial and the documents needed.
Understand the regulations and requirements around submitting a device to an agency in EU, UK, and rest of world.
Knows what doing a submission to the FDA really means.
Need experience submitting an IDE to the FDA.
The process of asking the FDA for permission to do a clinical trial.
Process of going to clinical trial
What is an SRD?
Understands 5 10 K PMA
Know how to execute an IDE and experience submitting IDEs. What do you submit an IDE for? Purpose behind the documentation. What are you asking the FDA to do?
Testing an assay and developing an assay according to FDA CFR Part 820.
Must have Assay development.
IDE for clinical
PMA which Premarket Authorization
FDA Submission
An assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte).Our Client, An American clinical laboratory, is seeking a Regulatory Affairs Specialist II
Location: Remote
Position Type: IT Full Time
Job Summary:
With minimal supervision, responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of Client products domestically (United States) and internationally (EU/Canada/ROW). Reviews and recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to international/recognized standards and procedures. Keeps abreast of all regulatory registration regulations, approval processes, standards and changes. Participates in the interactions with representatives from the Food and Drug Administration (FDA), Authorized Representative, Competent Authorities, Notified Bodies and other regulatory agencies on defined matters to achieve approval to sell Client products. Recommends strategies for earliest possible approvals of products. Maintains a library of standards, guidance documents.
Job Responsibilities:
Participate on project teams as regulatory or as RA/QA/CA representative.
Develop plans to receive approvals to sell products identified in the marketing sales plan.
Maintain knowledge and information of requirements to market products domestically and in all countries outside the U.S.
Timely preparation of regulatory submissions to the FDA, international dossiers/technical files required for CE Mark for EU countries and other international product registration files as required for ROW distribution.
Interacts with representatives from the Food and Drug Administration (FDA), Notified Body, Authorized Representative and other regulatory agencies to resolve issues or questions in the applications.
Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.
Reviews product changes to determine if these changes affect product labeling and/or product registration/submissions.
Skills and Experience:
with a minimum of 5 years experience in a regulated industry. Three-four years regulatory submissions work in domestic/international registrations and IVDR experience required.
Experience with IVDR/ IVD PMA submissions preferred.
LANGUAGE SKILLS: Ability to read and analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from employees, managers, vendors or customers. Ability to effectively communicate plans, issues and resolve problems/conflicts in a project team setting.
MATHEMATICAL SKILLS: Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.
REASONING ABILITY: Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to handle multiple projects and prioritize tasks/deliverables. Ability to interpret a variety of instructions furnished in written oral, diagram, or schedule form.
EDUCATION: Bachelor's Degree(Required), Master's Degree.
Salary Range: $100,000 - $120,000
- 2 Days Ago
VP, Regulatory Affairs Specialist
- Jefferies
-
Jersey, NJ
FULL_TIME
- Regulatory Affairs Specialist Position This hire will be a member of the Firm’s Regulatory group which is responsible for exam oversight, branch inspections, regulatory change tracking, governance rel...
- 3 Days Ago
C08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALIST PHARMACOVIGILANCE SPECIALIST
- Artech LLC
-
Madison, NJ
FULL_TIME
- Job Description: Position is Onsite (Lawrenceville/New Brunswick) Pharmacovigilance (PV) Analytics and Reporting Specialist, PV Analytics Center of Excellence JD The Pharmacovigilance (PV) Analytics a...
- 21 Days Ago
Director, Regulatory Affairs
- Lumanity
-
Morristown, NJ
OTHER
- Overview / About us Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate ev...
- 16 Days Ago
Regulatory Affairs Manager
- Katalyst Healthcares & Life Sciences
-
Madison, NJ
CONTRACTOR
- Responsibilities: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform...
- 30 Days Ago
Senior Director, Commercial Regulatory Affairs
- Mitsubishi Tanabe Pharma
-
Jersey, NJ
OTHER
- Overview Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied ...
- 1 Month Ago
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0 Regulatory Affairs Specialist jobs found in Elizabeth, NJ area
Regulatory Affairs Specialist - Cosmetics
- Adecco
-
Morris Plains, NJ
- Adecco Creative and Marketing is partnering with an American multinational beauty company. We are searching for a Compli...
- 4/18/2024 12:00:00 AM
VP, Regulatory Affairs Specialist
- Jefferies
-
Jersey City, NJ
- Job Description Regulatory Affairs Specialist Position This hire will be a member of the Firm's Regulatory group which i...
- 4/18/2024 12:00:00 AM
Regulatory Affairs Specialist II
- Katalyst Healthcares & Life Sciences
-
Edison, NJ
- Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical ...
- 4/18/2024 12:00:00 AM
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...
- 4/18/2024 12:00:00 AM
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...
- 4/18/2024 12:00:00 AM
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...
- 4/16/2024 12:00:00 AM
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 ...
- 4/16/2024 12:00:00 AM
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...
- 4/15/2024 12:00:00 AM
About Elizabeth, New Jersey
Elizabeth is both the largest city and the county seat of Union County, in New Jersey, United States.[21] As of the 2010 United States Census, the city had a total population of 124,969, retaining its ranking as New Jersey's fourth most populous city, behind Paterson.
[22] The population increased by 4,401 (3.7%) from the 120,568 counted in the 2000 Census, which had in turn increased by 10,566 (+9.6%) from the 110,002 counted in the 1990 Census.[23] For 2017, the Census Bureau's Population Estimates Program calculated a population of 130,215, an increase of 4.2% from the 2010 enumeration, ran...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$85,828 to $115,023
Elizabeth, New Jersey area prices
were up 1.6% from a year ago
were up 1.6% from a year ago
What does a Regulatory Affairs Specialist do?
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