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Senior Regulatory Affairs Specialist
2 weeks ago
StimLabs Roswell, United StatesStimLabs is looking to hire a Senior Regulatory Affairs Specialist to join our Regulatory team. This role would report directly to our Chief Regulatory and Quality Officer. The ideal candidate has extensive experience partnering with R&D and marketing to review marketing material ...
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National Regulatory Affairs Specialist
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Titan Industries Oakwood, GA, United States FreelanceThe advertised workplace (Aschau, Erfurt or remote) will be discussed based on the applicant's place of residence. The training will take place over 6 weeks at the main location. · **Your responsibilities - challenging**: · - Support in implementing MDR 2017/745, related guidelin ...
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Regulatory Affairs Specialist
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Brenntag Norcross, United StatesStage Picture: · JobTitle: · Regulatory Affairs Specialist - Pharma · Location: · Norcross/USA · Employment Type: · Employee · Regulatory Affairs Specialist - Pharma · Our team in Norcross currently has an opening for a Regulatory Affairs Specialist - Pharma · YOUR ROLE ...
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Regulatory Affairs Specialist
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Medical Affairs Specialist
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Medical Affairs Specialist
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Public Affairs Specialist
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Federal Emergency Management Agency Atlanta, United States Full timeWhat will I do in this position if hired? · In this position, you will serve as a Public Affairs Specialist with External Affairs in Region IV. Typical assignments include: · Typical assignments include: · Developing external affairs communications plans and research, writing, an ...
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Specialist, Regulatory Affairs
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Student Affairs Specialist
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Principal Regulatory Affairs Specialist
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Abbott Laboratories company Atlanta, United StatesPrincipal Regulatory Affairs Specialist - Heart Failure (on-site) page is loaded · Principal Regulatory Affairs Specialist - Heart Failure (on-site) · Apply · locations · United States - Georgia - Atlanta · United States - California - Pleasanton · time type · Full time · ...
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Senior Specialist, Regulatory Affairs
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Senior Specialist, Regulatory Affairs
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Principal Regulatory Affairs Specialist
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Abbott Laboratories company Atlanta, United StatesAbbott 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 products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Principal Regulatory Affairs Specialist
1 hour ago
Abbott Atlanta, United StatesAbbott 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 products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Principal Regulatory Affairs Specialist
1 week ago
Abbott Laboratories Atlanta, United StatesAbbott 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 products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Faculty Affairs Specialist for Academic
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Faculty Affairs Specialist for Academic
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Principal Regulatory Affairs Specialist
2 weeks ago
Abbott Laboratories Atlanta, United States OTHERWorking at Abbott · At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to: · Career development with an international company where you can grow the career you dream of · Free med ...
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Avanos Alpharetta, United StatesCareer Opportunities: Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite Requisition ID 5871 -Posted - Alpharetta Office - United States - Quality Assurance, Regulatory & Compliance - Additional Posting Locations (1)Job Title: Principal Specialist, Regulator ...
Senior Regulatory Affairs Specialist - Roswell, United States - StimLabs
Description
StimLabs is looking to hire a Senior Regulatory Affairs Specialist to join our Regulatory team. This role would report directly to our Chief Regulatory and Quality Officer. The ideal candidate has extensive experience partnering with R&D and marketing to review marketing materials for HCT/P and devices.Although this person does not have to work out of our Roswell, GA office, ideally this person would be able to come into the office a minimum of one day a week.
Provides key Regulatory support and leadership to the StimLabs organization Promotes culture of regulatory excellence within the organization by raising awareness for regulatory standards and compliance, plans and participates in regulatory education activitiesPlans and/or contributes to the development of regulatory affairs strategy and related infrastructure for new productsRepresents organizations regulatory strategy when leading or contributing to various projectsLeads various department activities and actively participates in daily Regulatory activitiesDesigns, develops, and executes training programs to disseminate regulatory knowledge throughout the organizationMember of StimLabs internal audit team and maintains qualification as a lead auditor as defined by StimLabsCarries out the interest, priority, and strategy of the Regulatory Affairs Department when Regulatory management or leadership is absent.
Participates in daily operations of the Regulatory Affairs department Represents department by carrying out organizations regulatory strategy when reviewing labeling and promotional material review activities and provides regulatory support during claims substantiation according to applicable regulatory framework.
Carry out all necessary regulatory filing updates, depending on applicable regulatory framework, based upon organization requests for changes to labeling or other factors that that may have FDA or regulatory body implications (e.g., premarket submission)Provide regulatory input to Product Development team to support the design of protocols and test plans that substantiate relevant claims for marketing collateral or regulatory submissionsProvide regulatory support to Research and Development and Quality Control for test method development and validation in support of product development in accordance with applicable regulatory frameworkSupport organizations clinical efforts and designated team by drafting or reviewing Informed Consent documents, submissions, and supporting, authoring, and/or reviewing investigative brochures, clinical study protocols, report writing, and subsequent study publication as applicableSupport clinical site evaluation and qualification, as applicableMaintain or provide leadership/carry out activities for all necessary state licensure/certifications, export certifications, and domestic and international product registrations, etc., as needed, to ensure no lapse in licensure, certification, or registrationProvide leadership during development of regulatory submissions (e.g.
RFD, 510(k), eSTAR, Q Submission, TRG, IND/CTA, BLA, RMAT, FOIA, etc.) and submission strategy, maintaining and submitting in a timely manner aligned with organizational goals/prioritiesLead preparation for meetings with regulatory bodies and manage correspondence with regulatory agencies, as requested by management.
Maintain appropriate FDA establishment registration for all regulated products, providing periodic updates to registration or product listing, as neededResponsible for management of regulatory reporting activities including reportable Adverse Reactions, HCT/P Deviations, Recalls, Medical Device Reports, and any other applicable mandatory reporting as applicable to organization or as directed by managementRepresent Regulatory Affairs department in Change Control meetings to ensure applicable design elements are maintained and not deleted by the change, and to ensure that regulatory classification of the subject product/device is not impacted by the change, or if the regulatory classification is impacted by the change, that the appropriate regulatory justification is provided including submission of a new pre-marketing application, if necessary.
Provide leadership and assistance with regulatory inspections before and after inspectionCarry out, plan, and provide leadership in the application of risk management processesUnder the direction of Management, correspond with regulatory agencies as required including set up and maintenance of Electronic Submissions Gateway (ESG), Customer Collaboration Portal (CDRH Portal), or any other method of transmitting information and corresponding with a regulatory agency.
Responsible for requesting payment of any and all regulatory fees according to current regulatory requirements including establishment fees, accreditation fees or dues, or any applicable user feesMonitor evolving regulatory environment, regulations and standards, both domestic and international, along with developments relating to topics of interest or organization competitors.
Communicate relevant changes to management and, when requested, to the broader organizationEDUCATION/CERTIFICATION Bachelors degree in a science or technical field, with at least seven (7) years of Quality or Regulatory experience in a biologic, pharmaceutical, or FDA regulated facility; or an appropriate combination of education and work experience.
Regulatory experience in the field of tissue banking, pharmaceuticals, clinical trials, medical devices, and/or biologics is required.A graduate degree in pharmaceutical sciences (e.g., international biomedical regulatory affairs) or a Regulatory Affairs Certification (RAC) is preferred.
REQUIRED KNOWLEDGE Knowledge and understanding of Quality and Regulatory requirements, including FDA (21 CFR Parts 1271, 820, 210, 211, 312, 812, 801, 803, etc.), The American Association of Tissue Banks Standards for Tissue Banking , cGTP, cGMP, HCT/P Final Guidance on Minimal Manipulation and Homologous Use, regulatory submissions, regulated product marketing and labeling, clinical trials, and other applicable state, federal, or international regulations.
Must be detail oriented, well-organized, capable of working independently, and able to communicate clearly across cross-functional teams.Must have strong technical writing and interpersonal skills.#J-18808-Ljbffr
