Regulatory Affairs Manager jobs in Missouri

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
  • 22 Days Ago

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...
  • 13 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...
  • 10 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...
  • 9 Days Ago

P
Manager, Telecommunications Regulatory Operations
  • People People
  • Kansas, MO FULL_TIME
  • Conexon is a rapidly growing company working with Rural Electric Cooperatives to build advanced fiber to the home (FTTH) networks nationwide. This position will lead the timely and accurate preparatio...
  • 22 Days Ago

C
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...
  • 4/26/2024 12:00:00 AM

P
Regulatory Affairs Manager
  • Pharvaris
  • Boston, MA
  • Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases...
  • 4/26/2024 12:00:00 AM

K
Regulatory Affairs Manager
  • Kenvue
  • Skillman, NJ
  • Kenvue is currently recruiting for: Regulatory Affairs Manager This position reports to Director, Regulatory Affairsand ...
  • 4/26/2024 12:00:00 AM

K
Regulatory Affairs Manager
  • Kenvue Inc.
  • Skillman, NJ
  • Kenvue is currently recruiting for: Regulatory Affairs Manager This position reports to Director, Regulatory Affairs and...
  • 4/26/2024 12:00:00 AM

F
Regulatory Affairs Manager
  • Ferris Mfg. Corp.
  • Fort Worth, TX
  • Ferris Mfg. Corp., a successful and long-established Medical Device Manufacturer, is seeking a responsible, self-motivat...
  • 4/26/2024 12:00:00 AM

M
Regulatory Affairs Manager
  • Mindlance
  • Chicago, IL
  • Job Title: Regulatory Affairs Manager III Location: REMOTE Duration: 06 months with possible extension SUMMARY The Regul...
  • 4/26/2024 12:00:00 AM

F
Regulatory Affairs Manager
  • Ferris Mfg. Corp.
  • Fort Worth, TX
  • Ferris Mfg. Corp., a successful and long-established Medical Device Manufacturer, is seeking a responsible, self-motivat...
  • 4/24/2024 12:00:00 AM

C
Regulatory Affairs Manager
  • Custom Search, Inc.
  • Minnetonka, MN
  • Our mid sized medical device client is adding a Manager Regulatory Affairs to the team. The Manager ensures compliance w...
  • 4/22/2024 12:00:00 AM

Missouri is landlocked and borders eight different states as does its neighbor, Tennessee. No state in the U.S. touches more than eight. Missouri is bounded by Iowa on the north; by Illinois, Kentucky, and Tennessee across the Mississippi River on the east; on the south by Arkansas; and by Oklahoma, Kansas, and Nebraska (the last across the Missouri River) on the west. Whereas the northern and southern boundaries are straight lines, the Missouri Bootheel protrudes southerly into Arkansas. The two largest rivers are the Mississippi (which defines the eastern boundary of the state) and the Misso...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$131,285 to $185,184

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