Regulatory Affairs Manager jobs in Arizona

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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International Regulatory Affairs Manager
  • HRPivot, Inc
  • Tucson, AZ FULL_TIME
  • Company description:

    SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ. We manufacture and sell the world's first and only US Food and Drug Administration (FDA) and Health Canada approved total artificial heart as bridge to transplant for patients suffering from biventricular heart failure The SynCardia Total Artificial Heart™ is available in two sizes to accommodate patients’ diverse physiologies. The Freedom Portable Driver™ allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant. The SynCardia Total Artificial Heart™ has been successfully used in over 2,000 patients and is the most widely used and extensively studied total artificial heart in the world. For additional information and label information, visit us at www.syncardia.com.

    Position description:

    SynCardia is looking for an energetic International Regulatory Affairs Manager. The successful candidate will be responsible for managing SynCardia’s international product registrations in Canada, Europe, and in the rest of the world. Specific tasks will include planning, preparing, managing, monitoring, and budgeting the Company’s international regulatory affairs projects: coordinating and working with regulatory consultants; and managing and preparing submissions to authorities in SynCardia’s international markets. To this end, the International Regulatory Affairs Manager will be working together with Regulatory Affairs, Quality, R&D, and Clinical Affairs professionals at the Company's Tucson site. Moderate travel is required..

    Principal responsibilities:

    • Assist in the preparation of regulatory submissions and filings, such as applications, amendments, supplements, annual reports, deficiency letter responses, Form 483
    • responses, warning letter responses, adverse experience reports, recall communications, license renewals, registrations, reports, correspondence, and telecommunications
    • Gather, assemble, and prepare appropriate documents for submission supporting the EU and other international markets
    • Independently research regulatory issues and/or information as directed
    • Independently track and follow-up on Regulatory commitments to assure commitments are completed and maintained
    • Prepare documents, as directed, for internal use or submission to regulatory authorities
    • Support regulatory filing processes in collaboration with a multi-disciplinary professional support staff
    • Independently monitor and improve tracking/control systems for regulatory documents
    • Participate in Design Control meetings with Product Development to provide regulatory input
    • Initiate action to prevent the occurrence of nonconformities relating to the product, process, and Quality System
    • Identify and record potential problems relating to the product, processes, and Quality System
    • Initiate, recommend or provide solutions through designated channels
    • Other duties as assigned
    • Provide regular updates to the Director of Regulatory Affairs and Company management on clinical International Regulatory Affairs statuses, plans, budgets, timetables, and bottlenecks

    Requirements:

    • Minimum of 5 years of International Regulatory Affairs experience gained in a similar position with at least 3 years in the cardiovascular device arena
    • University degree from a top-tier academic institution in a relevant field
    • Extensive knowledge of relevant government regulations, standards and guidelines
    • Strong analytical and problem-solving skills & excellent interpersonal and communication skills & team player
    • Proven track record of working in a dynamic, international environment
    • Excellent written and spoken English

    Qualifications:

    • Proven experience of successfully directing the efforts of diverse teams located across multiple locations/time zones is required
    • Effective team builder and problem solver, exhibiting a collaborative management style and the ability to bring out the best in people through example
    • Strong regulatory and business mind; he/she should be able to visualize future strategy while also outlining and driving tactics to complete the milestones to successfully execute that strategy
    • Comfortable leading the execution of all aspects of International Regulatory Affairs including prioritization of projects
    • Advanced experience and knowledge of ISO 13485, MDR, MDSAP & 21 CFR 820
    • Excellent communicator who radiates compassion, integrity, and loyalty to SynCardia and its customers, partners, shareholders, and employee

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  • 3 Days Ago

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Regulatory Affairs Manager
  • Tessenderlo Kerley, Inc.
  • Phoenix, AZ FULL_TIME
  • Company DescriptionTessenderlo Kerley, Inc. is a company of diverse businesses unified by shared values. We serve the agricultural, mining, industrial, and water reclamation markets with a broad range...
  • 8 Days Ago

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Regulatory Affairs Manager
  • Tessenderlo Group
  • Phoenix, AZ FULL_TIME
  • Company Description Tessenderlo Kerley, Inc. is a company of diverse businesses unified by shared values. We serve the agricultural, mining, industrial, and water reclamation markets with a broad rang...
  • 19 Days Ago

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Marketing Operations Specialist/Manager (Remote Based - Part Time to Full Time)
  • OneSource Regulatory
  • REMOTE, AZ FULL_TIME|PART_TIME
  • Marketing Operations Manager - OneSource Regulatory Join the OSR Team to transform Marketing/Commercial Operations and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companie...
  • 1 Month Ago

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Regulatory Affairs Manager (European Union expertise)
  • Talentry, LLC
  • Tucson, AZ FULL_TIME
  • Job DescriptionRegulatory Affairs Manager (European Union expertise)Medical Device Company. Tucson, AZ140kTalentry is looking for a Regulatory Affairs expert with medical device experience in the Euro...
  • 11 Days Ago

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Regulatory Affairs Manager (Med Device; EU expertise)
  • Talentry
  • Tucson, AZ FULL_TIME
  • Regulatory Affairs Manager (European Union expertise)Medical Device Company. Tucson, AZOnsite (relo over time) 140k Talentry is looking for a Regulatory Affairs expert with medical device experience i...
  • 2 Months 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

Arizona (/ˌærɪˈzoʊnə/ (listen); Navajo: Hoozdo Hahoodzo Navajo pronunciation: [xòːztò xɑ̀xòːtsò]; O'odham: Alĭ ṣonak Uto-Aztecan pronunciation: [ˡaɺi ˡʂonak]) is a state in the southwestern region of the United States. It is also part of the Western and the Mountain states. It is the sixth largest and the 14th most populous of the 50 states. Its capital and largest city is Phoenix. Arizona shares the Four Corners region with Utah, Colorado, and New Mexico; its other neighboring states are Nevada and California to the west and the Mexican states of Sonora and Baja California to the south and so...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$134,868 to $190,233

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