Regulatory Affairs Manager jobs in Pittsburgh, PA

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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Regulatory Affairs Manager
  • Advanced Respiratory Technologies, Inc.
  • Cheswick, PA FULL_TIME
  • Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing a transformative artificial lung system for the treatment of chronic lung diseases. Our primary goals are: (1) to produce a means of permanent respiratory support for the hundreds of thousands of chronic lung disease patients who will not be able to receive a lung transplant and die each year and (2) Further develop our system to be utilized in treating and evacuating wounded soldiers from far-forward positions in close proximity to the battlefield to definitive care in the United States. Our company values and fosters a team based approach to accomplish these goals to transform the treatment of lung disease patients.

    We are seeking a highly motivated and talented individual to join our team as an Regulatory Affairs Manager. As a key member of our Medical Devices team, you will be responsible for developing and implementing regulatory strategies for our company's medical devices; leading the design and implementation 21 CFR 820 Quality Systems; developing and implementing regulatory strategies for our company's medical devices; performing risk analysis studies; authoring and submitting regulatory filings to the FDA, including 510k applications; and interfacing with regulatory consultants who will aid in the implementation of all of the above directives. In this position, you will collaborate with cross-functional teams to execute and deliver innovative engineering solutions that could help improve the respiratory health of people worldwide.

    The ideal candidate has a passion for innovation, is detailed-oriented, and proactive in their approach.

    Responsibilities

    Design and develop medical devices from concept through production release while adhering to design input requirements, project timelines, and quality standards.

    Interface with technicians to manufacture prototype medical devices

    Improve manufacturing processes.

    Conduct design analysis, modeling, and simulation to optimize device design and performance.

    Perform in vitro testing and analyze collected data

    Collaborate with cross-functional teams (e.g., product, manufacturing, quality, regulatory, clinical partners) throughout the product development process.

    Lead the preparation of technical reports, design history files, and regulatory filings for medical device submissions.

    Participate in design reviews, risk assessments, and post-market surveillance activities.

    Typical workweeks are 37.5 hours with some increases in working hours as project timelines dictate. This position has the flexibility for either hybrid or fully on-site work at our 1105 William Pitt Way, PIttsburgh, PA 15238 location. (Harmar Township)

    Initial interviews will be conducted via telephone or video formats.

    Requirements

    Bachelor's degree or Master's degree in Regulatory Science or a related degree.

    5 years of prior regulatory affairs experience in the medical device field.

    High proficiency in preparing and filing successful 510k submissions

    Strong understanding of FDA Quality System requirements for Class II and Class III medical devices

    Excellent communication skills and ability to work in a team environment.

    Willing to work either hybrid or fully on-site at our location in Harmar Township, (outside of Pittsburgh, PA)

    Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa.

    Benefits

    Benefits to working at Advanced Respiratory Technologies, Inc.

    Be part of a growing team and medical device company that is developing new technologies that could each year treat hundreds of thousands of patients who have chronic lung diseases.

    A benefits package that includes: Medical, Prescription Drug, Dental, and Vision plan packages

    Company Retirement contributions

    Paid Time Off

    Competitive Salary - $132,000-$142,000

    Flexible start time between 7 am and 9 am

    Hybrid work option

    When applying through workable you will be prompted with an optional survey to collect demographic data and for self-identification as a protected veteran and/or as an individual with disabilities.

    Advanced Respiratory Technologies, Inc. is a Drug-Free Workplace.

    Advanced Respiratory Technologies, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, age, marital status, family status, pregnancy, disease, genetic information, relationship to a person with a disability, and other categories protected by federal, state, or local law.

    EEO is the Law

    Applicants and employees are protected under Federal law from discrimination. To learn more, use the links below:

    Pay Transparency Non-Discrimination Provision

    Advanced Respiratory Technologies, Inc. follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, use the link below:

  • 6 Days Ago

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Manager, Regulatory Affairs Global CMC Strategy
  • Viatris
  • Canonsburg, PA FULL_TIME
  • Viatris Specialty LLCAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs...
  • 1 Month Ago

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Sr. Manager, Global Device Labeling Strategy - Regulatory Affairs
  • Bayer
  • Indianola, PA FULL_TIME
  • In Bayer’s Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the the...
  • 25 Days Ago

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Regulatory Affairs Coordinator
  • University of Pittsburgh
  • Pittsburgh, PA FULL_TIME
  • Regulatory Affairs Coordinator Equivalent relevant work experience may be substituted for degree requirement. This position is 100% remote. PA Child Abuse History Clearance, PA State Police Criminal R...
  • 4 Days Ago

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Regulatory Affairs Coordinator
  • The University of Pittsburgh
  • Pittsburgh, PA FULL_TIME
  • Regulatory Affairs Coordinator Med-Pediatrics - Pennsylvania-Pittsburgh - (24001969) Equivalent relevant work experience may be substituted for degree requirement. This position is 100% remote. PA Chi...
  • 7 Days Ago

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Regulatory Affairs Complaint Investigator (FDA)
  • ZOLL LifeVest
  • Pittsburgh, PA FULL_TIME
  • Location: Remote, PA, United States of America Cardiac Management Solutions At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that m...
  • 17 Days Ago

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0 Regulatory Affairs Manager jobs found in Pittsburgh, PA area

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Director, Precision Medicine and Digital Health - Global Regulatory Affairs
  • Takeda Pharmaceutical
  • Pittsburgh, PA
  • By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the...
  • 3/19/2024 12:00:00 AM

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Project Manager, Environmental Consulting
  • Tetra Tech, Inc.
  • Pittsburgh, PA
  • Our Commercial/Private Sector client group in Pittsburgh, PA is looking for an Environmental Project Manager to lead mul...
  • 3/19/2024 12:00:00 AM

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Biomedical Equipment Support Specialist
  • U.S. Food and Drug Administration
  • Pittsburgh, PA
  • ** Biomedical Equipment Support Specialist** **Department of Veterans Affairs** **Location** 1 vacancy in the following ...
  • 3/18/2024 12:00:00 AM

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System Rel & Support Spec Sr- Call Recording and Telephony
  • PNC Financial Services Group, Inc.
  • Pittsburgh, PA
  • Position Overview At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. ...
  • 3/18/2024 12:00:00 AM

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Clinical Quality & Regulatory Specialist - (Hybrid/Remote)
  • Highmark Inc.
  • Pittsburgh, PA
  • Company : Highmark Inc. Job Description : GENERAL OVERVIEW: Assures that all department activities are compliant with re...
  • 3/17/2024 12:00:00 AM

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Product Manager IV - Remote
  • Net Health
  • Pittsburgh, PA
  • About Net Health Belong. Thrive. Make a Difference. Are you looking for a meaningful and satisfying career where you hav...
  • 3/17/2024 12:00:00 AM

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Advisory Research Specialist
  • VOYA Financial Inc.
  • Pittsburgh, PA
  • Together we fight for everyone's opportunity for a better financial future. We will do this together - with customers, p...
  • 3/16/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Advanced Respiratory Technologies, Inc.
  • Pittsburgh, PA
  • Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing...
  • 3/15/2024 12:00:00 AM

Pittsburgh (/ˈpɪtsbɜːrɡ/ PITS-burg) is a city in the Commonwealth of Pennsylvania in the United States, and is the county seat of Allegheny County. As of 2018, a population of 308,144 lives within the city limits, making it the 63rd-largest city in the U.S. The metropolitan population of 2,362,453, is the largest in both the Ohio Valley and Appalachia, the second-largest in Pennsylvania (behind Philadelphia), and the 26th-largest in the U.S. Pittsburgh is located in the south west of the state, at the confluence of the Allegheny, Monongahela, and Ohio rivers. Pittsburgh is known both as "the ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$135,327 to $190,877
Pittsburgh, Pennsylvania area prices
were up 1.9% 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