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Public Affairs Specialist
2 days ago
Houston Forensic Science Center Houston, United StatesShift: First Shift · Reporting to the HFSC General counsel and Director of Government Affairs, the Public Affairs Specialist is responsible for executing strategic communication to ensure consistent messaging in alignment with organizational goals, under the direction of the exec ...
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Government Affairs Specialist
3 weeks ago
Harris County (TX) Houston, United StatesPosition Description · About Harris County Flood Control District: · The Flood Control District has the mission to reduce the risk of flooding in Harris County, the third most populated county in the United States, with a population in excess of 4.7 million, including the City of ...
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Public Affairs Specialist
1 week ago
Houston Forensic Science Center Houston, United StatesJob Description · Job DescriptionReporting to the HFSC General counsel and Director of Government Affairs, the Public Affairs Specialist is responsible for executing strategic communication to ensure consistent messaging in alignment with organizational goals, under the direction ...
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Government Affairs Specialist
1 week ago
Harris County (TX) Houston, United StatesPosition Description · About Harris County Flood Control District: · The Flood Control District has the mission to reduce the risk of flooding in Harris County, the third most populated county in the United States, with a population in excess of 4.7 million, including the City of ...
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Regulatory Affairs Specialist
3 weeks ago
Brenntag Houston, United StatesStage Picture:brenntag_other_8.jpgJobTitle:Regulatory Affairs Specialist - PharmaLocation:Houston/USAEmployment Type:EmployeeRegulatory Affairs Specialist - PharmaOur team in Houston currently has an opening for a Regulatory Affairs Specialist - PharmaYOUR ROLE & RESPONSIBILITIES ...
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Government Affairs Specialist
1 week ago
Harris County Houston, United StatesAbout Harris County Flood Control District: · The Flood Control District has the mission to reduce the risk of flooding in Harris County, the third most populated county in the United States, with a population in excess of 4.7 million, including the City of Houston, the nation's ...
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Government Affairs Specialist
4 days ago
Harris County Houston, United StatesPosition DescriptionAbout Harris County Flood Control District:The Flood Control District has the mission to reduce the risk of flooding in Harris County, the third most populated county in the United States, with a population in excess of 4.7 million, including the City of Houst ...
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Government Affairs Specialist
1 week ago
Harris County Houston, United StatesAbout Harris County Flood Control District: · The Flood Control District has the mission to reduce the risk of flooding in Harris County, the third most populated county in the United States, with a population in excess of 4.7 million, including the City of Houston, the nations ...
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Government Affairs Specialist
1 week ago
Harris County Houston, United StatesPosition Description · About Harris County Flood Control District: · The Flood Control District has the mission to reduce the risk of flooding in Harris County, the third most populated county in the United States, with a population in excess of 4.7 million, including the City ...
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Faculty Affairs Specialist
1 week ago
UTHealth Houston Houston, United StatesFaculty Affairs Specialist - School of Biomedical Informatics · Faculty Affairs Specialist - School of Biomedical Informatics · Location: · Texas Medical Center-Houston, Texas · Hot · Category: · Administrative/Office Support · UTHealth Houston School of Biomedical Informa ...
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Faculty Affairs Specialist
1 week ago
UTHealth Houston Houston, United StatesFaculty Affairs Specialist - School of Biomedical Informatics · Faculty Affairs Specialist - School of Biomedical Informatics · Location: · Texas Medical Center-Houston, Texas · Hot · Category: · Administrative/Office Support · UTHealth Houston School of Biomedical Informatics ...
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Faculty Affairs Specialist
1 week ago
The University of Texas Health Science Center at Houston Houston, United StatesFaculty Affairs Specialist - School of Biomedical Informatics · Location: · Texas Medical Center-Houston, Texas · Hot · Category: · Administrative/Office Support · UTHealth Houston School of Biomedical Informatics · Requisition #: 240000OG · What we do here changes the wo ...
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Public Affairs Specialist
3 weeks ago
Houston Forensic Science Center Houston, United StatesJob Description · Job DescriptionReporting to the HFSC General counsel and Director of Government Affairs, the Public Affairs Specialist is responsible for executing strategic communication to ensure consistent messaging in alignment with organizational goals, under the direction ...
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Regulatory Affairs Specialist
3 weeks ago
Brenntag Specialities Houston, United StatesOur team in · Houston · currently has an opening for a · Regulatory Affairs Specialist – Pharma · YOUR ROLE & RESPONSIBILITIES · Supporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety. · Completion of t ...
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Regulatory Affairs Specialist
3 weeks ago
Empower Pharmacy Houston, United StatesCompany Overview · Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing fac ...
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Faculty Affairs Specialist
1 week ago
The University of Texas Health Science Center at Houston Houston, United StatesFaculty Affairs Specialist - School of Biomedical Informatics · Location: · Texas Medical Center-Houston, Texas · Hot · Category: · Administrative/Office Support · UTHealth Houston School of Biomedical Informatics · Requisition #: 240000OG · What we do here changes the wo ...
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Government Affairs Specialist
1 week ago
County of Harris Texas Houston, United StatesAbout Harris County Flood Control District:The Flood Control District has the mission to reduce the risk of flooding in Harris County, the third most populated county in the United States, with a population in excess of 4.7 million, including the Cit Government, Specialist, Socia ...
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Senior Regulatory Affairs Specialist
1 week ago
Repsol Oil & Gas USA, LLC Houston, United StatesMonitor and participate in proceedings before state and federal regulatory agencies and other regulatory or government agencies that affect natural gas activities. Monitor and analyze wholesale electricity market design changes and provide input on s Regulatory Affairs, Regulator ...
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Senior Regulatory Affairs Specialist
3 days ago
ApTask Houston, United StatesJob Title: Senior Regulatory Affairs Specialist (Medical Devices) · Location: Remote · Duration: Long term contract · Job Description: · - Subject Matter Expert for Class II and Class III 510(K) submission. · -Hands on experience with 510(k) authoring, submissions, and communica ...
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Senior Patient Affairs Specialist
3 days ago
Baylor College of Medicine Houston, United States· Apply now » · Title: · Senior Patient Affairs Specialist · Division: · Ambulatory Operations · Schedule: · Monday to Friday 8 a.m. to 5 p.m. · Work Location: · Houston, TX · Salary Range: · $38,212 to $51,683 · FLSA Status: · Nonexempt · Requisition ID: · 17927 · Title: ...
Regulatory Affairs Specialist - Houston, United States - Healgen Scientific
Description
Regulatory Affairs SpecialistRegulatory Affairs | Houston, TXApply Now ) Back to SearchJoin us on our exciting journeyHealgen Scientific is a global leader in developing, manufacturing and commercializing In-Vitro Diagnostic test systems. Since our inception in 2007, we have strived to develop devices that meet and exceed industry standards.Our comprehensive portfolio of high quality, tailored solutions span multiple testing categories and analytes to meet various clinical and laboratory needs.
Our products include rapid visual tests, digital point of care (POC) devices, molecular diagnostics, and multiplex flow cytometry.About the roleThe purpose of a Regulatory Affairs Specialist is to ensure compliance with regulations and guidelines set by regulatory authorities in the medical devices industry.
They play a crucial role in ensuring that products meet the necessary legal and quality standards before they can be marketed or sold.
ResponsibilitiesEnsure timely and accurate regulatory submissions of medical device incident reporting.Review and approve Healgen and private brand labeling.
Create and submit applications for medical device registration, private label requests, and licenses to regulatory bodies.
Ensure timely and accurate completion of all required documentation for product registration and licensing.
Collaborate with internal teams to gather necessary information and supporting documents for regulatory submissions.
Stay up-to-date with regulatory requirements and changes related to product registration and licensing.
Coordinate and track the progress of regulatory submissions and address any issues or deficiencies identified by regulatory authorities.
Maintain and update regulatory databases and records, including but not limited to product registrations and licenses.
Monitor and track the status of product registrations and licenses, ensuring compliance with renewal and maintenance requirements.
Provide guidance and support to internal stakeholders on product registration and licensing requirements and processes.
Collaborate with cross-functional teams to ensure alignment between regulatory requirements and product development plans.
Monitor and evaluate post-market data and feedback from customers, healthcare professionals, and regulatory authorities to identify potential product issues, safety concerns, or adverse events.
Collaborate with cross-functional teams to investigate and assess complaints, adverse events, and other post-market feedback.Assist in developing and implementing regulatory strategies, gather regulatory requirements, support compliance activities, and contribute to strategy execution.
Complete other projects and responsibilities as assigned.
The Senior Level RA Specialist will perform the above duties with high independence and minimal guidance.
QualificationsEducation:
Bachelor's degree in a scientific discipline (biology, chemistry, bio-chemistry, genetics, or a heavily technical writing-based curriculum); MS or PhD preferred
Experience:
At least 3 years of work experience in the field.
Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
Experience with medical device or IVD industry.Skills and Competencies:
In-depth knowledge of medical device regulations and standards, including FDA regulations (such as 21 CFR Part 820), ISO 13485, and other global regulatory requirements (such as MDR in the EU).
Understanding of product development processes and ability to interpret technical documentation, including design specifications, verification and validation reports, and clinical data.
Strong analytical and problem-solving skills to assess regulatory implications and find solutions to compliance challenges.Strong written and verbal communication skills to effectively communicate with internal teams, external stakeholders, and regulatory authorities.
Attention to detail and ability to review and interpret complex regulatory documents, including regulatory submissions, labeling, and promotional materials.
Knowledge of quality management systems, including good manufacturing practices (GMP) and good documentation practices (GDP).
Certifications:
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)#J-18808-Ljbffr
