Regulatory Affairs Manager jobs in Minnesota

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, Regulatory Affairs
  • RION Inc
  • Rochester, MN FULL_TIME
  • Manager Regulatory Affairs

    Job details

    Job Type: Full-time

    Number of hires for this role:1

    Qualifications

    • Bachelors in Science / Masters (Preferred)
    • Regulatory Affairs Experience: Minimum 5 years

    Full Job Description

    Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion’s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women’s health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.

    The Regulatory Affairs Manager will prepare and submit regulatory agency applications, reports, or correspondence with minimal oversight and will report to the Sr. Director of Regulatory Affairs at Rion.

    Responsibilities:

    • Assist in the development, review, and approval of key documents, including abstracts, presentations, protocols for IND and BLA submissions that will meet regulatory requirements
    • Prepare simple to intermediate regulatory submissions including Annual Reports, Protocol Amendments, and Information Amendments
    • Draft regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards including proper eCTD format.
    • Analyze simple to intermediate changes for regulatory impact. Communicate impact to team and complete required documentation for decision.
    • Understand and apply regulations, standards, and guidance documents from health authorities related to the design, development, evaluation, or marketing of products.
    • Follow regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
    • Support activities such as audits and regulatory agency inspections.
    • Support responses to regulatory agencies regarding product information or issues.
    • Maintain current knowledge of relevant regulations, including proposed and final rules.
    • Assess the impact of proposed regulations and guidance documents.

    · Maintain regulatory or compliance documentation including communication logs. Identify regulatory compliance problems / recommend solutions

    • Participate in product development through involvement in project team meetings.
    • Work with clinical research organizations and related partners to assist in the development of clinical research studies and documents that generate data to support market authorizations or promotional materials.

    Qualifications:

    • One of the following combinations of education and experience is required: (A) a minimum of a bachelor’s degree plus 5 years of health regulated industry experience OR (B) a master level degree plus 4 years of health regulated industry experience.
    • A degree in a scientific discipline is preferred
    • Basic knowledge of the drug development process and regulatory submission and approval process is required
    • Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
    • Experience responding to FDA requests and interacting with FDA is required
    • Experience lifecycle management of IND/BLA applications is required
    • Demonstrated experience in critically reviewing and compiling regulatory documents is required
    • Previous biologic or pharmaceutical Regulatory experience is a plus
    • A proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required
    • The ability to effectively prioritize assignments for multiple products and projects simultaneously is required
    • Strong interpersonal and communication skills

    Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives.

    We provide a very competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion:

    Full Health, Dental and Vision Insurance for employees and their dependents.

    Health Insurance including PPO or High Deductible Health Plan with Health Savings Account.

    Dental Insurance

    Vision Insurance

    Flexible Spending Accounts (FSA)

    401K or IRA Retirement Savings

    Life Insurance basic life and supplemental life insurance options for self, spouse, children

    Short and Long-Term Disability Insurance

    Paid Time Off

    Paid Holidays

    Parking benefits

    Rion is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

    Benefits:

    • 401(k)
    • Dental insurance
    • Flexible spending account
    • Health insurance
    • Paid time off
    • Vision insurance

    Work Location:

    • Rochester, Minnesota or Remote

    Work Remotely:

    • Yes, with on-site visit to company Headquarters (Rochester, MN) at maximum twice a month

    Job Type: Full-time

    Pay: From $113,018.00 per year

    Benefits:

    • 401(k)
    • 401(k) matching
    • Dental insurance
    • Employee stock purchase plan
    • Flexible schedule
    • Flexible spending account
    • Health insurance
    • Health savings account
    • Life insurance
    • Paid parental leave
    • Paid time off
    • Retirement plan
    • Stock options
    • Vision insurance

    Experience level:

    • 5 years

    Schedule:

    • Monday to Friday

    Ability to Relocate:

    • Rochester, MN 55902: Relocate before starting work (Required)

    Work Location: Hybrid remote in Rochester, MN 55902

  • 8 Days Ago

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Senior Manager, Regulatory Affairs Biocides - Remote
  • Steris Corporation
  • Durham, NC FULL_TIME
  • Job Title: Senior Manager, Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs Durham, NC, US, 27560 Description: At STERIS, we help our Customers create a healthier an...
  • 20 Days Ago

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Regulatory Affairs Project Manager – Structural Heart
  • 3205 St. Jude Medical, Cardiology Division, I
  • Minnesota, MN FULL_TIME
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and ...
  • 5 Days Ago

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Regulatory Affairs Director: State Prog Admin Manager Prin
  • State of Minnesota
  • Saint Paul, MN FULL_TIME
  • Job Details Working Title: Regulatory Affairs Director Job Class: State Program Administrator, Manager Principal Agency: Commerce Department Who May Apply: Open to all qualified job seekers Date Poste...
  • 7 Days Ago

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Regulatory Affairs Specialist II
  • Benchmark Electronics, Inc
  • Winona, MN FULL_TIME
  • Benchmark provides comprehensive solutions across the entire product lifecycle; leading through its innovative technology and engineering design services, leveraging its optimized global supply chain,...
  • 20 Days Ago

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Regulatory Affairs Specialist
  • Medtronic
  • Rice, MN FULL_TIME
  • Careers that Change Lives Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimul...
  • 20 Days Ago

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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...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager (Chemical Labeling)
  • Astrix
  • Countryside, IL
  • The Regulatory Labeling Manager develops, coordinates, and implements regulatory strategies for products that require go...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Daikin Comfort
  • Waller, TX
  • Regulatory Affairs Manager Daikin Comfort Technologies Manufacturing, L.P. is seeking a skilled individual for our Regul...
  • 3/27/2024 12:00:00 AM

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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...
  • 3/27/2024 12:00:00 AM

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Global Regulatory Affairs Manager II
  • Yoh, A Day & Zimmermann Company
  • Fort Worth, TX
  • Job Description Job Description Global Regulatory Affairs Manager II - Fort Worth 9 month contract W2 Pay Rate: $55.00 -...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Beacon Hill Staffing Group
  • San Fernando, CA
  • **Role is Fully Onsite to Northridge, CA** ROLE SUMMARY To support the our business in maintaining regulatory compliance...
  • 3/25/2024 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...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Alameda Health System
  • Oakland, CA
  • Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditatio...
  • 3/25/2024 12:00:00 AM

Minnesota (/ˌmɪnɪˈsoʊtə/ (listen)) is a state in the Upper Midwest and northern regions of the United States. Minnesota was admitted as the 32nd U.S. state on May 11, 1858, created from the eastern half of the Minnesota Territory. The state has a large number of lakes, and is known by the slogan the "Land of 10,000 Lakes". Its official motto is L'Étoile du Nord (French: Star of the North). Minnesota is the 12th largest in area and the 22nd most populous of the U.S. states; nearly 60% of its residents live in the Minneapolis–Saint Paul metropolitan area (known as the "Twin Cities"). This area i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$140,795 to $198,589

Regulatory Affairs Manager in Wichita Falls, TX
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