Regulatory Affairs Manager jobs in O Fallon, MO

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)

I
Regulatory Affairs and Quality Manager (Remote)
  • Incubator New Businesses
  • Rolla, MO FULL_TIME
  • Regulatory Affairs and Quality Manager
    Incubator New Businesses
    Location REMOTE
    Permanent
    Full Time

    About Heraeus

    Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and technological leadership to create the most diverse products, all with one thing in common: World-class quality. Working with customers around the world, we shape the future and provide vital innovations in the areas of Metals & Recycling, Healthcare, Semiconductor & Electronics and Industrials. Heraeus is one of the top 10 family-owned companies in Germany and has a team of around 17,200 employees in 40 countries.

    About Engineered Tissue Solutions

    Engineered Tissue Solutions was acquired in 2021 by the Heraeus Group, a FORTUNE Global 500 listed and broadly diversified family-owned technology company. Learn more about Heraeus Group at www.heraeus.com.

    The following challenges await you:
    • Lead and own regulatory and quality functions to ensure compliance with applicable laws and regulations in development, manufacturing (via CMOs), and marketing of ETS products.
    • Develop and manage regulatory and quality procedures required to manage post market surveillance, product complaints, clinical feedback and evaluations, and field actions.
    • Ensure regulatory requirements are met and risk management considerations are addressed in the design control process and specific product development plans.
    • Coach and mentor the development and commercial team on regulatory and design control activities.
    • With support of external regulatory SME’s, provide regulatory guidance and strategy for new product development, product marketing and promotion, and interactions with the FDA or other regulatory bodies.
    • Create US regulatory submissions for 510k clearance and pre-market authorizations, with external SME or consultant support as needed.
    • Own and improve the quality management system, procedures, and training to enable efficient and compliant company operations.
    • Acts as the company Management Representative
    • Responsible for internal and external audits (FDA, notified bodies, suppliers, etc); ensure compliance with relevant FDA and ISO 13485 requirements.
    Your Profile:
    • 10 years experience in the medical device field in quality or regulatory roles with direct experience as described in the job requirements.
    • Bachelor’s or advanced degree in engineering or related science, materials research, or related field.
    • Strong understanding and experience with regulatory and quality requirements for product development, manufacturing, and marketing products under ISO 13485 and 21 CFR 820, GMP and FDA 510k and PMA pathways.
    • Hands-on and versatile mindset required to succeed in a small company or start-up environment.
    • Effective and efficient in a remote or hybrid work environment and working with associates across the US and Europe.
    • Competent and efficient technical writing skills.
    • Demonstrate discretion, confidentiality, and professionalism when representing the company.
    • ASQ certification and Regulatory Affairs Professional Society (RAPS) medical device certification preferred.
    • Experience in a small company or start-up environment.
    .joqReqDescription .float-right { position: relative; right: 0px; bottom: 40px; float: right; } .joqReqDescription .float-left { float: left; margin-top: 15px !important; } .openmind { width: 300px; } .badge { height: 80px; }

    Diversity is at the core of our Vision, Mission, and Values. Heraeus is committed to an inclusive workforce that fully represents many different cultures, backgrounds and viewpoints. We can provide you with the opportunity - and Open Space - where your ideas and career can grow and advance. A career with Heraeus offers attractive compensation, top-notch benefits, and an ideal environment that supports your professional development.

    In case of any questions, our HR team is available at hrdirect-americas@heraeus.com. You can also find more information at www.heraeus.com/careersusa.

    Keywords: wound care, regulatory, quality
  • 23 Days Ago

A
Regulatory Affairs Technical Writer
  • Actalent
  • Maryland, MO OTHER
  • Description:This position focuses on the creation, revision, and maintenance of technical documentation necessary for regulatory submissions and compliance within a regulated industry, such as pharmac...
  • Just Posted

M
Regulatory Affairs Specialist
  • MilliporeSigma
  • St. Louis, MO FULL_TIME,CONTRACTOR
  • Regulatory Affairs Specialist Onsite in St. Louis MO (3 days onsite, 2 remote) 2 positions to fill Pay: $30.00-$34.00 an hour based on experience 2 year contract opportunity to hire opportunity Must h...
  • 14 Days Ago

U
Regulatory Affairs Specialist-Pesticides
  • Us tech Solutions
  • Chesterfield, MO FULL_TIME
  • Company DescriptionUS Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ou...
  • 1 Month Ago

B
International Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist
  • bioMérieux
  • Hazelwood, MO FULL_TIME
  • What will be your activities at bioMérieux?The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist to support Latin America & Canada regi...
  • 11 Days Ago

U
Assistant Director, Nuclear Regulatory Affairs
  • University of Missouri-Columbia
  • Columbia, MO FULL_TIME
  • Hiring Department MU Research Reactor The University of Missouri Research Reactor (MURR), the most powerful university research reactor in the United States, stands as a beacon of nuclear research exc...
  • 10 Days Ago

Filters

Clear All

  • Filter Jobs by companies
  • More

0 Regulatory Affairs Manager jobs found in O Fallon, MO area

N
Metrics Specialist - REMOTE
  • Net Health
  • St. Louis, MO
  • About Net Health Belong. Thrive. Make a Difference. Are you looking for a meaningful and satisfying career where you hav...
  • 4/28/2024 12:00:00 AM

T
Regulatory Affairs Associate
  • The Fountain Group Llc
  • Saint Louis, MO
  • Currently seeking a Regulatory Affairs Associate for a prominent client of ours. This position is located in St. Louis, ...
  • 4/28/2024 12:00:00 AM

S
Senior Specialist, Grants & Analytics
  • Safety National
  • Saint Louis, MO
  • Stop searching. Start growing. It's time to build a meaningful career where you can grow, your ideas can thrive, and you...
  • 4/28/2024 12:00:00 AM

W
Securities Processing Senior Business Execution Consultant
  • Wells Fargo
  • Saint Louis, MO
  • Wells Fargo Securities Processing Senior Business Execution Consultant SAINT LOUIS , Missouri Apply Now Wells Fargo is s...
  • 4/28/2024 12:00:00 AM

W
Lead Business Accountability Specialist
  • Wells Fargo
  • Saint Louis, MO
  • Wells Fargo Lead Business Accountability Specialist SAINT LOUIS , Missouri Apply Now Wells Fargo is seeking a Lead Busin...
  • 4/28/2024 12:00:00 AM

L
Building Code Expert/Research Analysis Specialist
  • Lamar Johnson Collaborative
  • Overland, MO
  • About Us Lamar Johnson Collaborative (LJC) is a team of high-energy professionals. We share a passion for design, a coll...
  • 4/27/2024 12:00:00 AM

D
Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Chesterfield, MO
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

D
Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Saint Louis, MO
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

O'Fallon /oʊˈfælən/ is a city along Interstate 64 and Interstate 70 between Lake St. Louis and St. Peters in St. Charles County, Missouri, United States. It is part of the St. Louis Metropolitan Statistical Area. As of the 2010 census O'Fallon had a population of 79,329, making it the largest municipality in St. Charles County and seventh largest in the state of Missouri. O'Fallon's namesake in St. Clair County, Illinois is also part of the St. Louis Metropolitan Statistical Area. The two O'Fallons are one of the few pairs of same-named municipalities to be part of the same MSA. According to t...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$133,764 to $188,682
O Fallon, Missouri area prices
were up 0.7% 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