Regulatory Affairs Specialist

6 days ago

StocktononTees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

Job Title: Regulatory Affairs Specialist

Job Summary:

Fujifilm Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for the company's medical device regulatory activities. The successful candidate will be responsible for ensuring compliance with all applicable U.S. FDA medical device regulatory requirements, ISO 13485 standard requirements, and other applicable laws, regulations, and standards.

Key Responsibilities:

  • Designated Responsible Personnel for Device Marketing Authorization and Facility Registration
  • Perform Pre-Market U.S. FDA submissions (510(k) and PMA)
  • Provide feedback and recommendations to design teams regarding 510(k) submissions
  • Prepare European Union Technical Files and International Regulatory Submissions
  • Coordinate Import/Export/Customs activities
  • Evaluate customer complaints and determine Medical Device Reportability
  • Coordinate Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals
  • Interact with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs, and Sales teams
  • Perform Corrective and Preventive Action activities
  • Prepare documentation for remediation activities
  • Prepare Management Review Meeting presentations

Requirements:

  • Bachelor's degree highly preferred
  • Three (3) or more years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment
  • Broad knowledge of U.S. FDA medical device regulations and international medical device standard requirements
  • Excellent leadership, communication, collaboration, team work, and interpersonal skills
  • Superb ability to effectively communicate with staff members and business partners at all levels of the organization
  • Excellent computer and internet search skills
  • Strong ability to multi-task and meet business deadlines
  • Excellent organizational skills with an ability to think proactively and prioritize work

Physical Requirements:

  • The ability to sit up 75-100% of applicable work time
  • The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time
  • The ability to stand, talk, and hear for 75% of applicable work time
  • The ability to lift and carry up to ten pounds up to 20% of applicable work time
  • Close Vision: The ability to see clearly at twenty inches or less

Travel:

  • Occasional (up to 25%) travel may be required based on business need

Fujifilm is an Equal Opportunity Employer:

Fujifilm is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

  • Regulatory Affairs Specialist

    18 hours ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:FUJIFILM Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for the company's medical device regulatory activities. The successful candidate will be responsible for ensuring compliance with all applicable U.S. Food and Drug Administration (U.S. FDA)...

  • Regulatory Affairs Specialist

    16 hours ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:FUJIFILM Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for the company's medical device regulatory activities. The successful candidate will be responsible for ensuring compliance with all applicable U.S. Food and Drug Administration (U.S. FDA)...

  • Regulatory Affairs Specialist

    3 days ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job Title: Regulatory Affairs SpecialistFujifilm Corporation is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485...

  • Regulatory Affairs Specialist

    3 days ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job Title: Regulatory Affairs SpecialistFujifilm Corporation is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485...

  • Regulatory Affairs Specialist

    4 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    About the RoleFUJIFILM Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide critical support in maintaining compliance with U.S. FDA medical device regulatory requirements and ISO 13485 standards.Key ResponsibilitiesPerform U.S. FDA submissions and ensure timely compliance with regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    About the RoleFUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment.The company's medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance...

  • Regulatory Affairs Specialist

    2 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    About the RoleFUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment.The company's medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance...

  • Regulatory Affairs Specialist

    1 week ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    About the RoleFUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment.The company's medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance...

  • Regulatory Affairs Specialist

    1 week ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    About the RoleFUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment.The company's medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance...

  • Regulatory Affairs Specialist

    7 days ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    About the RoleFUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment.The company's medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance...

  • Regulatory Affairs Specialist

    1 week ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    About the RoleFUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment.The company's medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance...

  • Regulatory Affairs Specialist

    2 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job SummaryFujifilm Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support to our Medical Device business. This role will be responsible for ensuring compliance with all applicable U.S. Food and Drug Administration (FDA) medical device regulations, as well as international standards and laws.Key ResponsibilitiesDesignated...

  • Regulatory Affairs Specialist

    2 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

    Job SummaryFujifilm Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support to our Medical Device business. This role will be responsible for ensuring compliance with all applicable U.S. Food and Drug Administration (FDA) medical device regulations, as well as international standards and laws.Key ResponsibilitiesDesignated...

  • Director of Regulatory Science, Assistant/Associate/Professor, NTT

    3 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom University of the Pacific Full time

    Job SummaryThe University of the Pacific seeks a highly qualified Director of Regulatory Science, Assistant/Associate/Professor, NTT to lead its Master of Science in Regulatory Science program. This is a full-time, tenure-track position that requires a strong background in regulatory affairs and a passion for teaching and mentoring.Key ResponsibilitiesTeach...

  • Director of Regulatory Science, Assistant/Associate/Professor, NTT

    3 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom University of the Pacific Full time

    Job SummaryThe University of the Pacific seeks a highly qualified Director of Regulatory Science, Assistant/Associate/Professor, NTT to lead its Master of Science in Regulatory Science program. This is a full-time, tenure-track position that requires a strong background in regulatory affairs and a passion for teaching and mentoring.Key ResponsibilitiesTeach...

  • Customer Support Specialist

    2 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom PIB Group Full time

    **Job Summary**We are seeking a highly skilled and experienced Customer Support Specialist to join our team at PIB Group. As a key member of our customer service team, you will be responsible for providing exceptional support to our policyholders, ensuring their needs are met and exceeded.**Key Responsibilities:**Provide timely and effective support to...

  • Customer Support Specialist

    2 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom PIB Group Full time

    **Job Summary**We are seeking a highly skilled and experienced Customer Support Specialist to join our team at PIB Group. As a key member of our customer service team, you will be responsible for providing exceptional support to our policyholders, ensuring their needs are met and exceeded.**Key Responsibilities:**Provide timely and effective support to...

  • Rotating Equipment Specialist

    4 days ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Risktec Solutions Ltd Full time

    Job Title: Rotating Equipment SpecialistTV Rheinland is a leading provider of technical services worldwide, offering a broad range of testing, inspection, and certification services to ensure the safety, reliability, and regulatory compliance of engineering assets throughout their lifecycle.We are seeking a skilled Rotating Equipment Specialist to join our...

  • Rotating Equipment Specialist

    4 days ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Risktec Solutions Ltd Full time

    Job Title: Rotating Equipment SpecialistTV Rheinland is a leading provider of technical services worldwide, offering a broad range of testing, inspection, and certification services to ensure the safety, reliability, and regulatory compliance of engineering assets throughout their lifecycle.We are seeking a skilled Rotating Equipment Specialist to join our...

  • Rotating Equipment Specialist

    2 days ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Risktec Solutions Ltd Full time

    Job Title: Rotating Equipment SpecialistTV Rheinland is a leading provider of technical services worldwide, offering a broad range of testing, inspection, and certification services to ensure the safety, reliability, and regulatory compliance of engineering assets throughout their lifecycle.We are seeking a skilled Rotating Equipment Specialist to join our...