Regulatory Affairs Specialist jobs in Greenville, SC
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 Manager - Greer, SC
- Alltrista
-
Greer, SC
FULL_TIME
-
Alltrista Plastics LLC, is a subsidiary of Jadex Inc., and is a leading manufacturer in high-volume, precision injection molded parts. The company designs and manufactures with proprietary engineering processes and extensive manufacturing capabilities, from five (5) locations worldwide. From the first spark of an idea, through the design of the mold to the actual manufactured product, Alltrista Plastics focuses all efforts on delivering innovative plastic solutions. The company’s core markets include Consumer Products, Medical/Healthcare, Personal Care, Health & Beauty, Caps & Closures, and Packaging.
Regulatory Affairs Manager - Greer, SC
Position Summary
Reporting to the Director of Quality, the Regulatory Affairs Manager is responsible for ensuring that products for which Alltrista Plastics has design responsibility comply with relevant government statutory and regulatory requirements, that patient safety and product efficacy are at the forefront of business activities and additional customer requested information. This individual acts as the critical liaison among Alltrista, Alltrista’s medical device customers, and regulatory authorities. The position will also establish and manage a supplier approval program.
Primary Functions – Regulatory- Ensuring the health and safety of all employees and diligently adhering to all safety rules and regulations.
- Has a broad understanding of medical packaging and medical device statutory, regulatory, and consensus standard requirements. Knowledgeable about FDA, Health Canada, and EU requirements, completing dossier for Drug Master File, 21 CFR 177, and USP , , , and testing requirements.
- Provides regulatory expertise to quality managers, program managers, and senior management on new product development and existing product requirements. Stays up to date with the latest rules and regulations and keeps all quality location updated with changes.
- Manages current Drug Master File and preparation and submission of new regulatory documentation.
- Supports the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to Company regulatory information concerning current, pending, and future approvals and renewals.
- Ensures the cost of regulatory compliance is captured in new product introduction and charged back to customers if required.
- Assists in reviewing product and process documentation for assigned projects to ensure compliance with requirements and monitors renewals to strict deadlines. Manages annual DMF review and submission.
- Acts as liaison among multiple project teams to obtain significant information as well as to answer regulatory and supplier quality queries that may arise in a timely and efficient manner.
- Manages the Alltrista brand specification approval. Communicates changes to customers for design of existing products and company practices where necessary. Aids in the development of product trials and analytical and microbiological specifications. Interprets trial data and creates internal documents.
- Works with marketing for packaging or advertising approvals regarding use of FDA and ISO terminology.
- Research customer regulatory requests and prepare responses.
- Establishes a division level supplier quality program that aligns with Alltrista EcoVadis goals – Social Responsibility, Sustainability, Traceability, and Predictability.
- Plans and schedules audits and assesses the capabilities of suppliers. These audits and inspections can be conducted on-site or remotely.
- Outlines schedule in a manner to show cost of onsite audits to ensure cost is budgeted for the following year.
- Ensures that all non-conformances are documented in IQS and that corrective actions are taken and implemented on products or processes.
- Support Procurement resources to assistance supplier onboarding and cost reduction initiatives.
- Works with plant controllers to verify score card reviews are in place and being used as intended. Aids in ranking suppliers by rating their developmental processes and sending reviews to companies.
- Once program is established, reviews the quality costs of suppliers and provides feedback to both Director of Quality and Directory of Logistics.
- Certified Quality Auditor and Lead Auditor certification preferred.
- Minimum two to five years of experience in quality management, working in regulatory field with demonstrated successful performance.
- Familiarity with 21 CFR 820 medical device regulations, Good Manufacturing Practices, ISO 9001, ISO 13485 or similar quality systems.
- Strong writing skills and experience.
- Able to speak clearly and persuasively in all situations. This position functions as a representative to both internal and external parties. Effective communication is essential in establishing relationships with regulatory authorities, marketing department, manufacturing sites, customers, and other relevant technical functions.
- Competitive salary and bonus structure
- Full benefits package
- 401K with match
- Strong vacation and corporate holiday policy
- 1 Month Ago
Lawn Specialist
- TruGreen - Lawn Specialist - Greenville, SC
-
Cedar Mountain, NC
FULL_TIME
- TruGreen is Hiring Residential Lawn SpecialistsImmediate Openings in Greenville, SC At TruGreen, we are committed to our customers, our teams, our values, and the science of lawn care. A career with T...
- 3 Days Ago
Senior Regulatory Coordinator
- Global Lending Services
-
Greenville, SC
FULL_TIME
- Why GLS?Purpose: Access to affordable, reliable transportation is essential to leading productive work and personal lives, caring well for oneself, one’s family, and the needs of others. Through advan...
- 20 Days Ago
Regulatory Reporting Manager
- UNITED COMMUNITY BANK
-
Greenville, SC
FULL_TIME
- Regulatory Reporting Manager United Community Bank is hiring a Regulatory Reporting Manager. This position is responsible for supporting critical regulatory reporting mandates and deadlines. The Regul...
- 21 Days Ago
Vice President of Government Affairs
- Greenville Chamber
-
Greenville, SC
FULL_TIME
- The Greenville Chamber of Commerce is excited to announce an opportunity for a dynamic and experienced professional to join our team as the Vice President of Government Affairs to work with the Chambe...
- 20 Days Ago
Director of Finance and Revenue Strategy, Academic Affairs
- Furman University
-
Greenville, SC
FULL_TIME
- Director of Finance and Revenue Strategy, Academic Affairs Welcome to Furman University's Career Site! IMPORTANT: Load all documents in the My Experience area under Resume/CV. This may include your re...
- 24 Days Ago
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0 Regulatory Affairs Specialist jobs found in Greenville, SC area
Warehouse Manager
- Richelieu Hardware
-
Greenville, SC
- Company Overview Richelieu is a leading North American distributor, importer, and manufacturer of specialty hardware and...
- 4/26/2024 12:00:00 AM
Vice President of Finance
- Godshall Recruiting
-
Greenville, SC
- Salary: $90-140K What is your perfect fit? Are you passionate about continuing your finance career in the banking or cre...
- 4/24/2024 12:00:00 AM
Quality Assurance Engineer
- Spero Technology
-
Greenville, SC
- What You'll Do You will be part of the Regulatory Systems team, comprising of Diverse group of developers, designers and...
- 4/24/2024 12:00:00 AM
Director of Financial Aid - Hybrid remote
- Cmg
-
Anderson, SC
- Director of Financial Aid - Hybrid remote Job ID: 83010Job Type: Full TimeCategory: FinanceEducations: Posted: 2024-04-1...
- 4/23/2024 12:00:00 AM
Full Time Patient Services Representative (Front Desk) Powdersville, SC
- WellStreet Urgent Care
-
Greenville, SC
- We are looking to hire a Full-Time front desk/medical reception staff at our Powdersville clinic. Street address: 11402 ...
- 4/23/2024 12:00:00 AM
Vice President of Finance
- Godshall Recruiting
-
Greenville, SC
- Salary: $90-140K What is your perfect fit? Are you passionate about continuing your finance career in the banking or cre...
- 4/22/2024 12:00:00 AM
Internal Revenue Agent (Examiner) - Direct Hire, 12 Month Register AMENDED
- Department Of The Treasury
-
Greenville, SC
- Duties WHAT ARE THE APPEALS (AP), LARGE BUSINESS AND INTERNATIONAL (LB&I), SMALL BUSINESS SELF-EMPLOYED (SB/SE) AND TAX ...
- 4/22/2024 12:00:00 AM
Assistant Vice President, Chief Control Office Enablement
- HSBC
-
Buffalo, SC
- Our purpose - Opening up a world of opportunity - explains why we exist. Here at HSBC we use our unique expertise, capab...
- 4/22/2024 12:00:00 AM
About Greenville, South Carolina
Greenville is located at 34°50′40″N 82°23′8″W / 34.84444°N 82.38556°W / 34.84444; -82.38556 (34.844313, −82.385428), roughly equidistant between Atlanta (145 miles [233 km] southwest), and Charlotte, North Carolina (100 miles [160 km] northeast). Columbia, the state capital, is 100 miles (160 km) to the southeast.
Greenville is in the foothills of the Blue Ridge Mountains, a physiographic province of the larger Appalachian Mountains range, and includes many small hills. Sassafras Mountain, the highest point in South Carolina, is in northern Pickens County, less than 40 miles (64 km) northwe...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$70,561 to $94,563
Greenville, South Carolina area prices
were up 1.5% from a year ago
were up 1.5% 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