Regulatory Affairs Manager jobs in Alabama

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)

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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 office) - HYBRID ROLE

    Schedule: Permanent

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Manager of Regulatory Affairs - Medical Devices to join their internal team in the United States. You will have the responsibility and authority to manage programs and/or projects in support of the regulatory demands of the business. Previous experience with a medical device industry is required.

    Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

    POSITION SUMMARY

    The Manager Regulatory Affairs has the responsibility and authority to manage programs and/or projects in support of the regulatory demands of the business. Positions at this level administer day-to-day Regulatory Affairs department activities by directly or indirectly managing teams of employees or managing third-party vendors. Combines knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Have department/site level influence and be generally recognized as an expert resource within the department. Identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance. Identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Utilize technical regulatory skills to propose strategies on complex issues. This position may have direct supervisory responsibilities.
    Adheres to environmental policy, procedures, and supports department environmental objectives.

    Main Job Tasks and Responsibilities:

    With limited supervision, the RA Manager will be responsible for:
    A. Provides tactical and strategic regulatory leadership to the organization and manages one or more regulatory programs, including continuous improvement activities, compliance related projects and/or new product development.
    B. Leads projects, develops sound regulatory strategies for long-term registrations of new or modified products (e.g., 510(k)s, technical files, dossiers) for domestic and foreign submissions and registrations.
    C. Leads in the understanding and awareness of the US, EU and other international regulatory requirements to ensure compliance.
    D. Reviews and approves post-market changes, device labeling and marketing materials for compliance with applicable regulations
    E. Interprets regulatory requirements and oversees aspects of submission of licenses and authorizations for the maintenance of existing products, international registrations and dossiers including assessment of the impact product changes have on the status of regulatory licenses.
    F. Independently makes decisions regarding work processes or operational plans and schedules. Solves issues through information exchange, influence and active persuasion with or without direct authority to gain cooperation of other functions on program initiatives such as business development, life cycle management initiatives and/or new product development.
    G. Provides day-to-day instructions and suggested training activities to direct reports, as applicable; assigns projects or activities to individual contributors.
    Represents regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.
    H. Prepares the responses to regulatory agency inquiries and other correspondence (either directly or indirectly through supervision of others)
    I. Formulates policies for department/area of responsibility and responsible for recruiting professionals (as needed)
    J. Ensures organization compliance with all applicable regulations and policies. Assists with audits and inspections, as required.

    Education, Experience and Skills:

    Typically requires BS with 8 years of experience or Doctorate degree (e.g., PhD, PharmD, OD, JD) with equivalent experience.
    Strong communication, organizational, negotiation and interpersonal skills. Expert knowledge, understanding and application of principles concepts and practices of government regulations. Ability to organize and analyze technical data and identify issues or gaps. Demonstrated skills in area of staff support and development (directly or indirectly). Foundational regulatory knowledge to maintain legal status of products and minimize risk. Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, laboratories, marketing, etc.) and ability to effectively negotiate and influence upper management, affiliates, and Regulatory agencies are a plus. Self-motivated and committed to a team approach.

    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. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

    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 to 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.

    Key words: Project Manager, Medical devices, Product registrations, Technical Dossiers, 510(k)s, International regulatory requirements.

    #LI-PR1 #Senior #FULLTIME #LI-HYBRID
  • 9 Days Ago

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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...
  • 1 Day Ago

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Senior Psychologist Program Manager
  • U.S. Department of Veterans Affairs
  • Tuskegee, AL FULL_TIME
  • SummaryThis position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in accordance...
  • 10 Days Ago

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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 whil...
  • 9 Days Ago

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Senior Regulatory Affairs Program Lead - Medical Devices (HYBRID ROLE)
  • ClinChoice
  • Jacksonville, AL FULL_TIME
  • Senior Regulatory Affairs Program Lead - Medical Devices (HYBRID ROLE) at ClinChoice (View all jobs) Jacksonville, Florida, United States Location: Jacksonville, FL or Irvine, CA - Hybrid (2 days per ...
  • 9 Days Ago

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RN - Registered Nurse - Quality Improvement - Regulatory Affairs - AM (002)
  • UAB Health System
  • Birmingham, AL OTHER
  • To coordinate and facilitate performance improvement activities in accordance with hospital policy. To use evidence-based decision making combined with innovative, practical ideas to perform consultat...
  • 22 Days Ago

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Catalyst Life Sciences
  • Chicago, IL
  • Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existi...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Blueroot Health™
  • PURPOSE STATEMENT: This position will be responsible for managing and coordinating implementation of regulatory requirem...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Lumicity
  • This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and co...
  • 6/9/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Tandym Group
  • Stamford, CT
  • Top hospital in Fairfield county, CT, just over the border from Westchester county NY, is seeking an experienced Regulat...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Mastech Digital
  • Oakland, CA
  • Position: HIM Director-Regulatory Affairs Manager Location: Oakland CA USA 94612 (5 days onsite) Duration: 12+ Months (P...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • SS White Dental
  • Lakewood, NJ
  • SS White Dental is seeking a Senior Regulatory Affairs Manager to support our Regulatory team. Candidates should have a ...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Procter & Gamble
  • Reading, England
  • Job Location Reading Job Description P&G is a leading global consumer goods company whose winning brands are Procter & G...
  • 5/22/2024 12:00:00 AM

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 Manager jobs
$127,252 to $179,491

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019