Regulatory Affairs Director jobs in Greenville, SC

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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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

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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...
  • 21 Days Ago

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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...
  • 17 Days Ago

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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...
  • 18 Days Ago

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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...
  • 17 Days Ago

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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...
  • 8 Days Ago

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0 Regulatory Affairs Director jobs found in Greenville, SC area

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Pharmaceutical Quality Director
  • HTI
  • Greenville, SC
  • HTI has an immediate opening for an experienced Pharmaceutical Quality Technical Director for a large pharma manufacture...
  • 4/23/2024 12:00:00 AM

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Medical Records Clerk
  • Gentiva Hospice
  • Greenville, SC
  • Our Company: Gentiva Hospice is a member of the Gentiva family an industry leader in hospice, palliative, home health, a...
  • 4/23/2024 12:00:00 AM

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Safety Manager
  • DREICOR INC
  • Hendersonville, NC
  • SAFETY MANAGER- HENDERSONVILLE, NC OFFICE Dreicor is an industrial construction company that services clients throughout...
  • 4/23/2024 12:00:00 AM

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Customer Service Representative
  • CNG Holdings, Inc.
  • Taylors, SC
  • Job Description: General Function / Summary: As a financial services leader, we strive to make a difference in our custo...
  • 4/22/2024 12:00:00 AM

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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 ...
  • 4/21/2024 12:00:00 AM

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Construction Project Manager New Home
  • Cothran Properties, LLC
  • Greenville, SC
  • Are you ready to work for the best homebuilder in Greenville? Cothran Homes has also been ranked as one of the Best Plac...
  • 4/19/2024 12:00:00 AM

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Lead and Copper Regional Lead-Charlotte,NC
  • Black & Veatch
  • Greenville, SC
  • **Lead and Copper Regional Lead-Charlotte,NC** Date: Mar 27, 2024 Location: Charlotte, TX, US US Company: Black & Veatch...
  • 4/19/2024 12:00:00 AM

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Safety Manager Battery Manufacturing
  • Proterra Inc
  • Greenville, SC
  • ** Safety Manager Battery Manufacturing** **Job Category****:** Manufacturing **Requisition Number****:** MANAG002254 Sh...
  • 4/19/2024 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 Director jobs
$157,026 to $223,641
Greenville, South Carolina area prices
were up 1.5% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020