Regulatory Affairs Director jobs in Delaware

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 Professional 2
  • APN Software Services, Inc.
  • Newark, DE FULL_TIME
  • Client: Siemens

    Job title: Regulatory Affairs Professional 2 / IVDR International registration

    Location: Newark, DE 19702

    Duration: 12 Months

    Description

    Analyzes the requirements and prepares product related regulatory submissions.

    • Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
    • Identifies, analyzes and implements country specific requirements necessary for product related submissions.
    • Plans and prepares product related submissions with internal (e.g. Regional Units) or external organizations according to regulatory requirements.
    • Performs regulatory projects or acts as a member of the project steering group.
    • Submits required documentation/information to local authorities or internal.
    • Initiates and escalates necessary activities if deviations are identified.
    • Ensures creation of adequate documentation for audits/inspections.
    • Performs training within the organization in country specific regulatory requirements, if applicable.
    • Performs review of promotional material for regulatory compliance according to country specific requirements.
    • May represent the company in industry associations (Lobbying), if applicable.

    "Expands" Needs to consider processes and results, generated in other workflows and disciplines, implies conditions and environments, and values significance to contribute effectively to team results. Needs experienced level of analytical and distinctive conceptual skills to solve issues given, which may differ in size and nature. 3-5 years Thorough professional know-how in one Sub Job Family, based on practical experience and theoretical foundation. Focus on applying and expanding acquired knowledge base. Application of knowledge in broader professional context.
  • 3 Days Ago

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Regulatory Affairs Specialist
  • Siemens Healthineers
  • Newark, DE FULL_TIME
  • Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in heal...
  • 5 Days Ago

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Regulatory Affairs Specialist
  • NemoursCareerSite
  • Wilmington, DE FULL_TIME
  • Nemours is seeking a Regulatory Affairs Specialist to join our team in Wilmington, DE. Under the direction of the Manager of Regulatory & Accreditation Affairs, the Regulatory Affairs Specialist is re...
  • 1 Month Ago

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Regulatory Affairs Manager
  • Centrica Services Ltd (UK)
  • Hamburg, DE FULL_TIME
  • We are Centrica! We’re so much more than an energy company. We’re a family of brands revolutionising a cleaner, greener future. Working here is #MoreThanACareer - we’re powered by purpose. Together we...
  • 18 Days Ago

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Regulatory Affairs Specialist
  • Hologic Careers
  • Newark, DE FULL_TIME
  • Hologic is seeking a Regulatory Affairs Specialist to join our expanding Innovation Center located in Newark, DE. What to Expect: The Regulatory Affairs Specialist is expected to perform the coordinat...
  • 2 Months Ago

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Manager (m/f/d) Regulatory Affairs / GDP Quality Assurance
  • 2010 Gilead Sciences GmbH
  • Munich, DE FULL_TIME
  • For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve...
  • 6 Days Ago

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 6/11/2024 12:00:00 AM

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Head of Regulatory Affairs
  • EPM Scientific
  • Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
  • 6/10/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/10/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 6/8/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
  • 6/8/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Kaye/Bassman International
  • San Diego, CA
  • Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
  • 6/7/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs - Oncology
  • Mantell Associates
  • Boston, MA
  • Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
  • 6/7/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Chicago, IL
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/7/2024 12:00:00 AM

Delaware is 96 miles (154 km) long and ranges from 9 miles (14 km) to 35 miles (56 km) across, totaling 1,954 square miles (5,060 km2), making it the second-smallest state in the United States after Rhode Island. Delaware is bounded to the north by Pennsylvania; to the east by the Delaware River, Delaware Bay, New Jersey and the Atlantic Ocean; and to the west and south by Maryland. Small portions of Delaware are also situated on the eastern side of the Delaware River sharing land boundaries with New Jersey. The state of Delaware, together with the Eastern Shore counties of Maryland and two co...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$172,446 to $245,606

Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019