Regulatory Specialist

1 week ago


Gainesville, United States Exactech Full time
Regulatory Specialist

Department: Regulatory

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Sr. Manager, Regulatory Affairs

Description

The purpose of the Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.

Key Responsibilities
  • Preparing and maintaining FDA pre-market submissions, Canadian device license applications and international product registrations for medical devices.
  • Assist in preparing and submitting MDD Class III Design Dossiers for review by the Notified Body.
  • Providing regulatory support for new product development projects:
    • Design team participation
    • Design Control requirements
    • CE marking requirements / Technical File (STED) / Design Dossier compilation
    • Pre-market regulatory submissions
    • Canadian device license applications
    • International product registrations - STED File organization
    • Product labeling review and approval
  • Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification, including the application of Design Control and Risk Management processes.
  • Participate as needed in the complaint handling, corrective and preventive action and internal quality audit processes.
  • Knowing and applying Exactech's Quality Management System and any appropriate federal and international standards.
  • Providing knowledge and support to the company's different business units to enable operation within company and regulatory guidelines.
  • Assisting and supporting other employees, teams, and sales personnel as necessary.
  • Practicing Exactech's Values.
Skills Knowledge and Expertise

Education:
  • Bachelor's Degree from an accredited institution required.
Experience:
  • Minimum 2 years experience in FDA/ISO medical devices quality management system standards required
  • 2 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations preferred
Functional/Technical Knowledge, Skills and Abilities Required:
  • Technical writing skills required
  • Experience in Design Controls
  • Working knowledge of windows-based office productivity tools including word processor and spreadsheet


  • Gainesville, Florida, United States Exactech Full time

    Job OverviewExactech is seeking a highly skilled Regulatory Compliance Specialist to join our team.


  • Gainesville, United States IFS Coatings, Inc. Full time

    Product Regulatory Specialist is responsible to work with and maintain systems for the management of raw material and product records, work within established procedures and templates using product safety software tool to ensure the creation of globally compliant SDS's and labels, ensure product compliance with global chemical control laws, work with...


  • Gainesville, Texas, United States IFS Coatings, Inc. Full time

    Are you a detail-oriented professional with a passion for regulatory compliance and chemical coatings? Do you thrive in a dynamic environment where no two days are the same? We're seeking a highly skilled Regulatory Compliance Specialist to join our team at IFS Coatings, Inc.About UsWe're a leading manufacturer of high-quality coatings, committed to...


  • Gainesville, Florida, United States State of Florida Full time

    Company OverviewThe State of Florida Department of Agriculture and Consumer Services is a dynamic organization dedicated to protecting and promoting the state's agricultural industry.Job DescriptionWe are seeking an Administrative Support Specialist to join our team. As a key member of our Import Certification Program, you will play a crucial role in...


  • Gainesville, Florida, United States VetJobs Full time

    At VetJobs, we're seeking a highly organized and detail-oriented Administrative Assistant I to join our team. This is an exciting opportunity to work in a dynamic environment where you'll be responsible for supporting the High Risk Detector Dog Program.About UsVetJobs is a leading provider of job opportunities for veterans and military-affiliated...


  • Gainesville, Florida, United States Exactech Full time

    About ExactechExactech is a leading company in the medical device industry, committed to delivering innovative solutions that improve patient outcomes.


  • Gainesville, Florida, United States VetJobs Full time

    VetJobs Job Opportunity:This role is a vital part of our organization's High Risk Detector Dog (HRDD) Program. As an Administrative Support Specialist, you will serve as the primary support position, responsible for maintaining import notification databases, tracking inspection conclusions, and submitting records in a timely and accurate manner.The ideal...


  • Gainesville, Florida, United States University of Florida Health Full time

    **Job Summary:**We are seeking a skilled RN Specialist to join our team at the University of Florida Health.**About the Role:As an RN Specialist, you will possess specialized knowledge and skills to provide patient-centric care to patients in a physician's office setting. You will be responsible for providing clinical nursing assessment, acting as a patient...


  • Gainesville, Texas, United States HHS, LLC Full time

    Job OverviewWe are seeking a skilled Registered Dietitian to join our team as a Nutrition Therapy Specialist. In this role, you will work closely with patients, families, and healthcare professionals to provide personalized nutrition therapy.About the RoleThis is a part-time position that requires 20 hours of work per week. The successful candidate will be...


  • Gainesville, Florida, United States Xpedient Logistics Full time

    Job DescriptionXpedient Logistics is a leading 3PL provider with extensive experience in warehousing services, transportation management, and supply chain optimization.We are seeking an experienced Warehouse Operations Specialist to join our team. As a key member of our warehouse operations team, you will play a critical role in ensuring accuracy,...


  • Gainesville, United States HHS, LLC Full time

    About HHSHHS, LLC is a private family-owned business dedicated to delivering quality-driven customer service and providing exceptional care for its team members. Founded in 1975 as Hospital Housekeeping Systems, today HHS offers services including housekeeping, food, and facility management to nearly 1,000 customers across six industries.We are growing...


  • Gainesville, Florida, United States University of Florida Full time

    About the RoleThe University of Florida is seeking a Compliance Program Specialist to join its team. This is an exciting opportunity for someone with a strong background in compliance and regulatory affairs.Job DescriptionWe are looking for a highly motivated individual who can independently conduct compliance reviews in various systems, including UFIRST,...


  • Gainesville, Florida, United States Lincoln Electric Full time

    About the Role:As a Welding Excellence Specialist at Lincoln Electric, you will play a critical role in driving operational excellence by fostering a culture of safety, regulatory compliance, and continuous improvement across all plants.Key Responsibilities:Functionally manage and support plant-level EHS teams to ensure compliance with corporate policies and...


  • Gainesville, Florida, United States North Florida Foundation for Research and Education Inc Full time

    About the JobThis is a full-time position at North Florida Foundation for Research and Education Inc. The Clinical Research Coordinator Specialist will be responsible for supporting the enrollment of patients into clinical trials.Job DescriptionThe Clinical Research Coordinator Specialist will work with the principal investigator to meet or exceed study...


  • Gainesville, Florida, United States KA Recruiting Inc. Full time

    Job Title: Clinical Care SpecialistLocation: Near Gainesville, FloridaAbout the Job:A leading healthcare organization is seeking a skilled Clinical Care Specialist to join their team. This full-time and permanent role offers opportunities for growth and a comprehensive benefits package.Key Responsibilities:Provide exceptional patient care as a Respiratory...


  • Gainesville, Florida, United States Xpedient Logistics Full time

    Job DescriptionXpedient Logistics is a leading provider of third-party logistics services, offering expertise in warehousing, transportation management, supply chain optimization, and order fulfillment. We are seeking a highly skilled Warehouse Operations Specialist to join our team.Key Responsibilities:Conduct regular audits of warehouse operations,...


  • Gainesville, Florida, United States Xpedient Logistics Full time

    Xpedient Logistics is a reputable 3PL provider with extensive experience in warehouse services, transportation management, and supply chain solutions.Job Type: Full-timeSalary and Benefits:$18.73 per hour, paid bi-weeklyWe offer competitive insurance benefits, including medical, dental, vision, and life insurancePaid time off and holidaysAbout the Role:A...


  • Gainesville, Georgia, United States Xpedient Logistics Full time

    About Xpedient LogisticsXpedient Logistics is a full-service 3rd party logistics provider. Our expertise spans warehousing services, transportation management, supply chain management, order fulfillment, and labor needs.Job SummaryWe are seeking an experienced Warehouse Operations Specialist to join our team. As a key member of our warehouse operations team,...

  • Clinical Specialist

    12 hours ago


    Gainesville, United States Haven Hospice Full time

    Our Company Haven Hospice Overview The Clinical Specialist is the heart of our organization performing professional nursing practice for hospice by processing workflow to ensure that patient care can continue in a timely manner. The Clinical Specialist will also document compliance of all policies and procedures follow all federal, state, and local...


  • Gainesville, Florida, United States University of Florida Health Full time

    Job SummaryUniversity of Florida Health seeks a compassionate and skilled LPN to provide high-quality nursing care to our patients in the comfort of their own homes. As a HomeCare LPN Specialist I, you will work collaboratively with our interdisciplinary team to develop and implement individualized care plans that promote patient independence, dignity, and...