Regulatory Affairs Manager jobs in Greenville, SC

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

A
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.
    Secondary Functions – Supplier Quality Auditor
    • 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.
    Key Qualifications
    • 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.
    Specifics:
    • Competitive salary and bonus structure
    • Full benefits package
    • 401K with match
    • Strong vacation and corporate holiday policy
    Jadex Inc and its Businesses do not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
  • 1 Month Ago

U
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...
  • 13 Days Ago

G
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...
  • 12 Days Ago

G
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...
  • 12 Days Ago

F
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...
  • 16 Days Ago

F
Assistant Vice President of Academic Affairs and University Registrar
  • Furman University
  • Greenville, SC FULL_TIME
  • Assistant Vice President of Academic Affairs and University Registrar Welcome to Furman University's Career Site! IMPORTANT: Load all documents in the My Experience area under Resume/CV. This may incl...
  • 3 Days Ago

Filters

Clear All

  • Filter Jobs by companies
  • More

0 Regulatory Affairs Manager jobs found in Greenville, SC area

W
Warehouse Associate
  • Walmart
  • Greenville, SC
  • **Job Summary:** As a Warehouse Associate at Walmart, you will play a crucial role in the efficient operation of the dis...
  • 4/19/2024 12:00:00 AM

S
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...
  • 4/19/2024 12:00:00 AM

W
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 ...
  • 4/18/2024 12:00:00 AM

N
Special Loans Specialist I (On-Site)
  • Newrez LLC
  • Greenville, SC
  • Who we are Shellpoint Mortgage Servicing (SMS) is one of America's top-five non-bank mortgage-servicing companies. What ...
  • 4/17/2024 12:00:00 AM

J
Regulatory Affairs Manager - Greer, SC
  • JadeX
  • Greer, SC
  • Job Description Job Description Alltrista Plastics LLC, is a subsidiary of Jadex Inc., and is a leading manufacturer in ...
  • 4/16/2024 12:00:00 AM

E
Patient Access Specialist
  • Ensemble Health Partners, Inc.
  • Greenville, SC
  • Thank you for considering a career at Ensemble Health Partners! Ensemble Health Partners is a leading provider of techno...
  • 4/16/2024 12:00:00 AM

H
Registered Dietitian (RD)
  • HHS Culinary and Nutrition Solutions, LLC
  • Greenville, SC
  • Registered Dietitian at St Francis Downtown in Greenville, SC. Outpatient and inpatient positions available! Starting sa...
  • 4/15/2024 12:00:00 AM

H
Executive Chef (Healthcare)
  • HHS Culinary and Nutrition Solutions, LLC
  • Greenville, SC
  • Executive Chef, Healthcare Food Service This Position Will Require Relocation Salary $60,000.00 Support the healing jour...
  • 4/15/2024 12:00:00 AM

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 Manager jobs
$127,978 to $180,521
Greenville, South Carolina area prices
were up 1.5% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020