Regulatory Affairs Specialist jobs in Alabama
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
Senior Regulatory Affairs Specialist - Medical Devices (HYBRID ROLE)
- ClinChoice
-
Jacksonville, AL
FULL_TIME
-
Senior Regulatory Affairs Specialist - Medical Devices (HYBRID ROLE)
at ClinChoice (View all jobs)
Jacksonville, Florida, United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....
ClinChoice is searching for a Senior Regulatory Affairs Specialist (Medical Devices) Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
POSITION SUMMARY
Guided by supervision, the individual in this role provides regulatory support in a number of areas, including but not limited to:
A. Reviewing/analyzing modifications to product, manufacturing process, packaging, etc. to determine impact of registration status of approved products and to determine appropriate regulatory pathway.
B. Reviewing and approving advertising and promotion materials
C. Performing re-registration activities to support registrations Outside of the United States (OUS)
D. Assisting in developing regulatory strategies for new product development initiatives.
E. Performing regulatory operations tasks including archiving/assembling/publishing regulatory filings and other health authority communications.
Adheres to environmental policy, procedures, and supports department environmental objectives.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES
Under supervision, the Senior Regulatory Affairs Specialist will be responsible for:
A. Coordinating and submitting registrations for maintenance of existing products, including international registrations, updates to Technical Documentation Files, Declarations of Conformity, etc.
B. Reviewing engineering/device change requests.
C. Researching, collecting data, responding to requests from regulatory agencies to prepare and submit documentation for US and OUS marketing clearances/approvals, as well as to provide routine information to business associates and their affiliates.
D. Provides regulatory guidance to various internal teams/department personnel and responds to regulatory related product requests.
E. Represents the regulatory affairs department in cross-functional project teams, plans and schedules regulatory deliverables to achieve project milestones.
F. Prepares associated product labeling to meet registration requirements for new or modified products; reviews product labeling associated with existing product to ensure compliance to regulatory requirements.
G. Assists in development of best practices, work instructions for Regulatory Affairs processes and
H. Provides Regulatory Affairs support for internal and external quality system audits.
QUALIFICATIONS
Minimum education required for competent performance:
Bachelor’s Degree - Scientific Discipline (preferred)
Minimum of 3 years of work experience within the Medical Device or Pharmaceutical industry or 0-3 years with a PharmD/PhD. Strong communication, organizational, negotiation and interpersonal skills
General knowledge, understanding and application of principles, concepts and practices related to FDA regulations. Regulatory knowledge to maintain legal status of products and minimize risk. Broad based technical knowledge and skills in diverse business functions (e.g., R&D, Operations, QA, laboratories, marketing, etc.) are a plus. Self-motivated and committed to a team focused approach to problem solving. Ability to organize and analyze technical data and identify issues or gaps. Ability to provide innovative solutions within the boundaries of regulation.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-PR1 #LI-Hybrid #Contract - Just Posted
Regulatory Specialist
- AllerVie Health
-
Homewood, AL
FULL_TIME
- At AllerVie Health, our team members are unified around our mission to help patients achieve and maintain optimal health and quality of life - free from the symptoms and suffering of allergies, asthma...
- 5 Days Ago
Manager of Regulatory Affairs - Medical Devices (HYBRID ROLE)
- ClinChoice
-
Jacksonville, AL
FULL_TIME
- Manager of Regulatory Affairs - Medical Devices (HYBRID ROLE) at ClinChoice (View all jobs) Jacksonville, Florida, United States Location: Jacksonville, FL or Irvine, CA - Hybrid (2 days per week from...
- Just Posted
Senior Regulatory Affairs Program Lead - Medical Devices
- ClinChoice
-
Jacksonville, AL
FULL_TIME
- Senior Regulatory Affairs Program Lead - Medical Devices at ClinChoice (View all jobs) Jacksonville, Florida, United States Location: Jacksonville, Florida, United States - Hybrid (2 days per week fro...
- 10 Days Ago
Information Technology Specialist (CUSTSPT)
- U.S. Department of Veterans Affairs
-
Tuskegee, AL
FULL_TIME
- SummaryThis position is in the Office of Information Technology (OIT), End User Services (EUS), End User Operations (EUO) and is located at a Veteran Affairs (VA) facility. Work involves the planning ...
- 2 Days Ago
Information Technology Specialist (CUSTSPT)
- U.S. Department of Veterans Affairs
-
Tuscaloosa, AL
FULL_TIME
- SummaryThis position is in the Office of Information Technology (OIT), End User Services (EUS), End User Operations (EUO) and is located at a Veteran Affairs (VA) facility. Work involves the planning ...
- 3 Days Ago
Regulatory Affairs Specialist jobs at Popular Companies
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...
- 6/2/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory aff...
- 6/2/2024 12:00:00 AM
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/1/2024 12:00:00 AM
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...
- 6/1/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 5/31/2024 12:00:00 AM
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...
- 5/31/2024 12:00:00 AM
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
- Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
- 5/30/2024 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 ...
- 5/29/2024 12:00:00 AM
About Alabama
Alabama (/ˌæləˈbæmə/) is a state in the southeastern region of the United States. It is bordered by Tennessee to the north, Georgia to the east, Florida and the Gulf of Mexico to the south, and Mississippi to the west. Alabama is the 30th largest by area and the 24th-most populous of the U.S. states. With a total of 1,500 miles (2,400 km) of inland waterways, Alabama has among the most of any state.
Alabama is nicknamed the Yellowhammer State, after the state bird. Alabama is also known as the "Heart of Dixie" and the "Cotton State". The state tree is the longleaf pine, and the state flower is...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$69,980 to $93,785
Most Popular Cities in Alabama 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