Sarah Weber

Sarah Weber Email and Phone Number

Holistic Wellness Coach and Educator @ Self Employed
Milwaukee, WI, US
Sarah Weber's Location
Greater Milwaukee, United States
Sarah Weber's Contact Details

Sarah Weber personal email

n/a
About Sarah Weber

Are you trying to make healthy choices in your life but still feel exhausted, sore, or like your mind isn’t as sharp as it used to be? Maybe you can’t figure out why you keep getting every virus going around, or can’t get restful sleep? If you answered yes to any of the questions above, know that you are not alone, and that you can make lifestyle changes to improve your mind and your body.I used to count my calories and work out at the gym at least 3 times a week. But those work outs were hard, and my days at the office were more exhausting than they used to be. I was tired, sore, not getting the sleep I needed, and I suffered from unexplained headaches. I felt much older than I really was. I decided to do something about it.My wellness journey led me to understand how vital the ability to assimilate nutrients in the body is, that it matters more the type of calories you take in than the number of calories, that stress does more to the human body than we like to recognize and that stress – good or bad - is cumulative. I learned that the key to feeling good is to find equilibrium, balance, to return the body to a place of homeostasis. How each person does that is unique to them but includes similar considerations. It would be my privilege to help you on your wellness journey. Together, we will set short and long-term goals for your health and wellness. We will look at nutrition, assimilation of nutrients (a.k.a. digestion), areas of your body most challenged by stress and different sources of stress. I will take time to listen, ask questions, and help you understand what all those aches and pains, the sleepless nights and exhaustion are really telling you your body needs.If you want to reclaim your energy, clear your mind, lift your spirit, feel human again, and if you are willing to welcome change into your life, I’d love to offer you a free 30-minute consultation. You can contact me directly @ SarahWeberND@gmail.com or send me a message here on LinkedIn. I’m looking forward to learning more about you and your challenges as well as sharing a bit more about my approach. Thanks!Sarah

Sarah Weber's Current Company Details
Self Employed

Self Employed

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Holistic Wellness Coach and Educator
Milwaukee, WI, US
Employees:
681323
Sarah Weber Work Experience Details
  • Self Employed
    Holistic Wellness Coach And Educator
    Self Employed
    Milwaukee, Wi, Us
    View
  • Self Employed
    Holistic Wellness Coach & Educator
    Self Employed Apr 2017 - Present
    Greater Milwaukee
    NATURAL HEALTH: Provide recommendations for foods and supplements to support a strong immune system. Supply digestive enzymes to aid in the absorption of nutrients from food.HOLISTIC WELLNESS EDUCATION: Share what I have learned about the immune system, the digestive system and how they are inter-related. Teach people how to support their immune system while caring for their digestive system.FINDING BALANCE: Realizing that mind and body two pieces of the same whole, that when one is struggling, so is the other. I work with you to determine what you can do in your already full, busy life to make sustainable changes that fit your lifestyle.
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  • Philips
    Global Corrections And Removals Expert
    Philips Nov 2021 - Present
    - Project lead for a global team that scoped and created a suite of 7 "evergreen" training courses focused on industry norms around corrections and removals. Training targets those directly involved in the process as well as those upstream, downstream and accountable for corrections and removals.- Authored global corrections and removals regulatory reporting work instruction and accompanying determination template document. Collaborated with and gained buy-in from global business partners.- Ad interim Senior Manager Corrections and Removals for 2 business units, leading a team of 5. Role taken on concurrently with regular position.- Serve as a resource for those working through various corrections and removals with questions about process, regulations, inputs and/or outputs of the process and industry norms.- Support risk management activities through document reviews.- Helped deliver on-site training on the link between risk management and corrections and removals. - Interface with regulators such as FDA as needed.- Member of corrections and removals leadership team.- FDA inspection support.- Internal audit support and response.- Represented Global Corrections and Removals Director in discussions to resolve external stakeholder concerns, including those of global regulatory bodies.- Conduct internal reviews and audits of risk and corrections and removals records as requested.
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  • Ibm- Watson Health
    Regulatory Affairs Program Manager
    Ibm- Watson Health Jul 2017 - Nov 2021
    Lead global organization through effective execution of product recalls/field corrective actions. Support MDSAP audits as subject matter expert for product recalls/field corrective actions. Prepare to meet EU Medical Device Regulation requirements for Field Corrective Actions. Work to close open recalls. Assist w/post-market issue investigations, risk management and CAPA activities to drive regulatory reporting decisions for field corrective actions globally. Work with new product development teams to develop go to market strategy, determine language requirements, and review product labeling. -Terminated 50+ global recalls receiving complements from FDA for clear reporting of completion evidence. Completed Health Canada Section 65 reports, final FSCAs for the EU & worked w/Australian sponsor to close field safety corrective actions internationally.-Engaged cross-functional team members to implement field corrective action strategy resulting in completion of global recall activities in less than 180 days-Implemented global recall standard operating procedure & regulatory reporting requirements for countries w/promulgated post market regulatory requirements resulting in multiple successful MDSAP audit outcomes-Made regulatory reporting decisions for field corrective actions. Submitted recall data to global regulators/local representatives-Trained and mentored colleagues on corrective action regulations, requirements & preparing FDA closure request packages-Shared knowledge of global field corrective action regulations & execution strategies w/other key stakeholders in the IBM Watson Health organization including executive leadership-Provided regulatory support for product development teams by developing regulatory go to market strategy, gaining device clearances globally, & maintaining current device licensing-Supported Risk Management activities by providing process inputs -Presented to senior leadership at quarterly Quality Management Reviews
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  • Mortara Instrument
    Senior Regulatory Affairs Manager
    Mortara Instrument Jun 2015 - May 2017
    Obtain new and maintain current regulatory clearances for Patient Monitoring devices based on sales opportunities in each country or region. Identify emerging regulatory requirements globally and assess changes to devices for regulatory impact. Subject matter expert for global product recalls across all product lines. Provide support for risk management activities.- Wrote two Traditional 510k submissions, both including clinical trial data - Prepare global submissions including but not limited to Health Canada Class III medical device license, CSDT for Asian markets, and EU DoC- Participation in product development doc reviews & design reviews- Authoring Global regulatory plans- Implemented and am Subject Matter Expert for global product recall process, including global regulatory reporting requirements for countries with promulgated post market regulatory requirements- Trained in ISO14971. Provide support for risk remediation efforts, and complete post market risk assessments. Provided input to current risk management procedures.- Provide audit support
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  • Ge Healthcare
    Regulatory Affairs Leader - Product
    Ge Healthcare Sep 2001 - Jun 2015
    Partner with the cross-functional product team to determine market strategy for a novel device. Develop regulatory strategy in support of market strategy, gain device clearances globally, work with international regulatory team to maintain current device licensing in strategic markets, manage regulatory holds internationally, identify emerging regulatory requirements globally and assess changes to devices for regulatory impact.- Assisted in writing Traditional 510k requiring clinical trial support for a novel device- Prepare responses to FDA 510k inquiry submitted via third party reviewer- Support engineering team in determining regulatory requirements for new products - Prepare global submissions documents for countries in Latin America, Middle East, Asia, Canada and European Union-Provide regulatory support on OEM business venture in areas of pre-market submission, product labeling and post-market preparedness - Review and provide input to marketing collateral in preparation for sale of a novel device- Worked with engineering, sales and marketing teams to prepare for FDA UDI requirements
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  • Ge Healthcare
    Post Market Regulatory Affairs Leader
    Ge Healthcare Oct 2008 - Aug 2013
    Milwaukee, Wi
    Regulatory affairs contact for all issues that may lead to a field action for multiple areas of the business working with high acuity medical devices. Regulatory voice for over 50 simultaneous field actions with an average installed base of 6000 units, worked with high level business executives to minimize regulatory risk while meeting regulatory requirements, provided inputs to customer communications on recalls, engaged in process improvement projects and provided audit support.-Prepared global regulatory reporting decisions and communicated them to the global regulatory team ensuring a consistent approach to post-market issues in all regions with promulgated regulations-Retained all regulatory documentation as required per regulations, with zero 483 findings across 7 different manufacturing sites-Lead a project to incorporate changes in regulations to a companywide procedure-Advised legal, commercial and service teams on how to compliantly address product issues with customers
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  • Ge Healthcare
    Field Action Specialist (Post-Market Regulatory)
    Ge Healthcare Jan 2007 - Oct 2008
    - Understanding and meeting FDA requirements for field actions in the medical device industry- Working with global vigilance managers to ensure we are meeting country specific regulatory requirements with respect to field actions- Writing and maintaining reportability decision documents- Identifying and implementing process improvements globally- Educating non-regulatory teams of the requirements we must meet
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  • Ge Healthcare
    Fulfillment Specialist
    Ge Healthcare Dec 2005 - Jan 2007
    - Organized multiple Kaizen events at customer sites. - Supported the consultant leading the Kaizen (lean) events. - Revised collateral used by consultants during the events.
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Sarah Weber Skills

Quality Assurance Healthcare Regulatory Affairs Regulatory Submissions Regulatory Reporting Regulatory Strategy Regulatory Risk Regulatory Requirements Regulatory Filings Quality System Iso 13485 Strategy Regulations Leadership Fda Capa Corrective And Preventive Action Cross Functional Team Leadership Design Control Management Medical Devices Product Development U.s. Food And Drug Administration

Sarah Weber Education Details

  • Marquette University
    Marquette University
    Organizational Communication, General
    View
  • Trinity College Of Natural Health
    Trinity College Of Natural Health
    Natural Health And Wellness
  • Cnhp
    Cnhp
    Natural Health

Frequently Asked Questions about Sarah Weber

What company does Sarah Weber work for?

Sarah Weber works for Self Employed

What is Sarah Weber's role at the current company?

Sarah Weber's current role is Holistic Wellness Coach and Educator.

What is Sarah Weber's email address?

Sarah Weber's email address is sa****@****ibm.com

What schools did Sarah Weber attend?

Sarah Weber attended Marquette University, Trinity College Of Natural Health, Cnhp.

What skills is Sarah Weber known for?

Sarah Weber has skills like Quality Assurance, Healthcare, Regulatory Affairs, Regulatory Submissions, Regulatory Reporting, Regulatory Strategy, Regulatory Risk, Regulatory Requirements, Regulatory Filings, Quality System, Iso 13485, Strategy.

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