Regulatory Affairs Specialist jobs in Maine
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
- DivIHN Integration Inc
-
Scarborough, ME
TEMPORARY
-
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.
Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Sivanesan at 224 369 0756
Title: Regulatory Affairs Specialist II
Location: Scarborough, ME
Duration: 7 Months
Description
The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations.
Exempt/Non Exempt: Non Exempt Years
Skills: Knowledge of regulations and standards affecting IVDs and/or biologics
Duties
Responsible for implementing and maintaining the effectiveness of the quality system.
Supports manufacturing/operations day to day activities for change control.
Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities.
Interprets and applies regulatory understanding to support of products and teams.
Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
Handles regulatory activities involved in documentation, labeling, field support.
Applies regulatory and technical knowledge to a wide variety of complex work assignments. Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
This job description will be reviewed periodically and is subject to change by management.
Responsibilities- Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
- Provides regulatory support for diagnostic product development and commercial diagnostic products.
- Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
- Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
- Researches and communicates scientific and regulatory information in order to write submission documents.
- Compiles and publishes all material required for submissions, license renewals, and annual registrations.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
- Develops internal procedures and tools.
- Conducts informational or training sessions for stakeholders.
- Organizes and maintains hard copy and electronic department files.
- Demonstrates commitment to the development, implementation and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering microbiology, immunology, medical technology, or the equivalent combination of education and experience.
- 4 years’ experience in Regulatory Affairs role.
- Strong knowledge of IVDR and EU regulatory requirements is required.
- 1 years’ experience in an IVD or medical device manufacturing environment.
- 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
- Good knowledge of EU and international regulations.
- Demonstrated written and verbal communication skills.
- Strong time management skills, with the ability to work on multiple projects simultaneously.
- Ability to work independently as well as within a team.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status. - 12 Days Ago
Regulatory Affairs
- Maine Molecular Quality Controls, Inc
-
Saco, ME
FULL_TIME
- Position Title: Quality Assurance/Regulatory Affairs Specialist II Employer: Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products...
- 2 Months Ago
Regulatory Affairs Associate
- ORPC
-
Portland, ME
FULL_TIME
- About Us ORPC improves people’s lives, and their environment, through sustainable energy solutions. Constantly pushing the boundaries of innovation, ORPC brings marine renewable energy technology and ...
- 25 Days Ago
Program Manager- Accreditation & Regulatory Affairs
- MaineHealth
-
Portland, ME
FULL_TIME
- Summary **RN or clinical experience preferred. Primarily responsible for all operational aspects of the assigned program including development, implementation, maintenance, and evaluation. Works with ...
- 10 Days Ago
Quality Assurance/Regulatory Affairs Associate
- KMA Human Resources Consulting
-
Saco, ME
FULL_TIME
- Quality Assurance/Regulatory Affairs Associate Maine Molecular Quality Controls, IncSaco, Maine MMQCI is seeking a QA/RA Associate, to be based in their Saco Maine Location\nRequirements of the QA/RA ...
- 2 Months Ago
Regulatory specialist
- The Fountain Group LLC
-
Scarborough, ME
FULL_TIME
- Hello, This is ShivaRaj from The Fountain Group, we are currently seeking a Regulatory Specialist II for a prominent client of ours. This position is located in Scarborough, ME. Details for the positi...
- 9 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
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Regulatory Affairs Specialist
- Experis
-
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
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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
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
Regulatory Affairs Specialist
- Baylor College of Medicine
-
Texas City, TX
- Division: Office of Research Work Arrangement: Onsite only Location: Texas Medical Center, Houston, TX Salary Range: $54...
- 6/8/2024 12:00:00 AM
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
About Maine
To the south and east is the Atlantic Ocean and to the north and northeast is New Brunswick, a province of Canada. The Canadian province of Quebec is to the northwest. Maine is both the northernmost state in New England and the largest, accounting for almost half of the region's entire land area. Maine is the only state in the continental US to border only one other American state (New Hampshire to the South and West).
Maine is the easternmost state in the United States in both its extreme points and its geographic center. The town of Lubec is the easternmost organized settlement in the United...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$74,284 to $99,549
Most Popular Cities in Maine for Regulatory Affairs Specialist Jobs
What does a Regulatory Affairs Specialist do?
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