Current jobs related to Regulatory Affairs Specialist - StocktononTees, Stockton-on-Tees - Fujifilm Corporation

  • Regulatory Affairs Specialist

    3 weeks ago

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

    Job Title: Regulatory Affairs SpecialistJob SummaryFujifilm Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for medical device regulatory requirements. The successful candidate will be responsible for ensuring compliance with U.S. FDA regulations, ISO 13485 standard requirements, and other...

  • Regulatory Affairs Specialist

    3 weeks ago

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

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

  • Regulatory Affairs Specialist

    4 weeks 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 products. The successful candidate will be responsible for ensuring compliance with all applicable U.S. FDA medical device regulatory requirements, ISO 13485...

  • Regulatory Affairs Specialist

    3 weeks ago

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

    Job SummaryFujifilm Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for the company's medical device regulatory requirements. The successful candidate will be responsible for ensuring full compliance with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulations, ISO...

  • Regulatory Affairs Specialist

    3 weeks ago

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

    Job SummaryFujifilm Healthcare Americas Corporation is seeking a highly skilled Regulatory Affairs Specialist to provide support for medical device regulatory requirements. The ideal candidate will have a strong understanding of U.S. FDA regulations and international standards.Key ResponsibilitiesDesignated Responsible Personnel for Device Marketing...

  • Regulatory Affairs Specialist

    4 hours ago

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

    Job TitleRegulatory Affairs Specialist - Compliance ExpertAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to provide support for our company's medical device regulatory requirements. The successful candidate will have a strong understanding of U.S. FDA regulations and international standards, including ISO 13485.Key...

  • Regulatory Affairs Professional

    2 weeks ago

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

    OverviewFUJIFILM 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.Job Title: Regulatory Affairs SpecialistJob PurposeThis position provides Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation,...

  • Regulatory Reporting Specialist

    2 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Northern Powergrid Full time

    Job Title: Regulatory Reporting AnalystLocation: Dewsbury/CastlefordDirectorate: Energy SystemsAbout the Role:We are seeking a highly skilled Regulatory Reporting Analyst to join our Energy Systems Team. The successful candidate will support the timely production of regulatory reporting information, collaborate with colleagues to determine project...

  • Regulatory Affairs Specialist

    4 weeks ago

    Stoke-on-Trent, Stoke-on-Trent, United Kingdom fish4.co - Jobboard Full time

    Job Title: Regulatory Affairs SpecialistAre you a detail-oriented and analytical individual with a passion for regulatory compliance? Do you have experience in a compliance role within an FCA regulated firm? We are seeking a highly skilled Regulatory Affairs Specialist to join our team at fish4.co - Jobboard.Key Responsibilities:Support the Head of...

  • Regulatory Governance Specialist

    3 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom North Tees & Hartlepool NHS Foundation Trust Full time

    Main duties of the roleThe role requires someone with a flexible and focused approach to minute taking, who can record information in an impartial way without imposing their own opinions. The role demands someone who can adapt to a varied and demanding workload and recognize the changing needs of the governance structure and the Corporate Secretariat...

  • Regulatory Reporting Specialist

    3 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Northern Powergrid Full time

    Job DescriptionWe are seeking a skilled Regulatory Reporting Analyst to join our Energy Systems Team at Northern Powergrid.The successful candidate will support the Lead Compliance Analyst in ensuring the provision of accurate and timely regulatory submissions to Ofgem.Key Responsibilities:Supporting the timely production of regulatory reporting...

  • Compliance Officer

    4 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Reed Full time

    Reed Business Support is seeking a Compliance Officer to join our client, a prestigious legal firm based in Teesside. This role is crucial in ensuring the client's practices, records, and controls meet the highest standards of regulatory compliance and accreditation requirements. The Compliance Officer will play a vital role in maintaining the client's...

  • Regulatory Affairs Director

    3 weeks ago

    Southend-on-Sea, Southend-on-Sea, United Kingdom OLYMPUS EUROPA SE & CO. KG Full time

    Regulatory Affairs DirectorOlympus Europa SE & Co. KG seeks a highly skilled Regulatory Affairs Director to oversee regulatory activities in the UK and Ireland region.The successful candidate will be responsible for managing registrations, overseeing reviews of marketing materials, and providing regulatory support to Commercial, Procurement, and Distribution...

  • Senior Audit Manager

    3 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Hays Specialist Recruitment Limited Full time

    Your new career path in auditing awaits with Hays Specialist Recruitment Limited. We are seeking a highly skilled Audit Manager to join our team and take on a challenging role in the UK market.Key Responsibilities:Manage a portfolio of audit clients and ensure compliance with GAAP and regulatory requirements.Deliver revenue and profitability targets, and...

  • Senior Audit Manager

    3 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom Hays Specialist Recruitment Limited Full time

    Your new career path awaits at Hays Specialist Recruitment Limited. We are seeking an experienced Audit specialist to join our team as a Manager. This is a fantastic opportunity to progress your Audit career with one of the leading UK Accountancy firms. With outstanding benefits and flexible working arrangements, you will have the ability and motivation...

  • Mechanical Maintenance Specialist

    3 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom First Recruitment Group - IT Careers Full time

    Job SummaryWe are seeking a skilled Mechanical Maintenance Specialist to join our team at First Recruitment Group - IT Careers. As a Mechanical Maintenance Specialist, you will be responsible for carrying out high-quality inspections to ensure pressure equipment complies with current regulatory and statutory requirements.Key ResponsibilitiesConduct...

  • Mechanical Inspection Specialist

    4 weeks ago

    Stockton-on-Tees, Stockton-on-Tees, United Kingdom First Recruitment Group Full time

    Job OverviewWe are seeking a skilled Mechanical Inspection Specialist to join our team. As a key member of our inspection team, you will be responsible for conducting high-quality inspections of pressure equipment to ensure compliance with regulatory and statutory requirements.The ideal candidate will have a strong background in mechanical engineering and a...

  • Regulatory Affairs Specialist

    4 weeks ago

    Stoke-on-Trent, Stoke-on-Trent, United Kingdom Uniting People Full time

    {"title": "Regulatory Affairs Specialist", "description": "£30k per annum Monday-Friday 8.30am-5.00pm (will consider hybrid after training - 2 days @ home)Up to 35 days holiday, including Bank HolidaysAs a key member of our Compliance team, you will provide timely and accurate regulatory and industry advice to the business, regular risk reporting and...

  • Regulatory Affairs Specialist

    4 weeks ago

    Stoke-on-Trent, Stoke-on-Trent, United Kingdom Uniting People Full time

    {"title": "Regulatory Affairs Specialist", "description": "£30k per annum Monday-Friday 8.30am-5.00pm (will consider hybrid after training - 2 days @ home)Up to 35 days holiday, including Bank HolidaysAs a key member of our Compliance team, you will provide timely and accurate regulatory and industry advice to the business, regular risk reporting and...

  • Head of Corporate Communications

    1 month ago

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

    Job Title: Head of Corporate CommunicationsThe Head of Corporate Communications plays a critical role in shaping the company's image and reputation. Reporting directly to the SVP, Chief Administrative Officer & Treasurer of Fujifilm Holdings America Corporation, this position is part of the company's Leadership Team.Key Responsibilities:Lead a team of 19...

Regulatory Affairs Specialist

2 months ago

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

About the Role

FUJIFILM 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 imaging, ultrasound, endoscopy, and endosurgery.

The Synapse Enterprise Imaging portfolio provides healthcare professionals with the imaging and data access needed to deliver a complete patient record.

REiLI, FUJIFILM's artificial intelligence initiative, combines FUJIFILM's rich image-processing heritage with cutting-edge AI innovations to inspire a new tier of clinical confidence.

The In-Vitro Diagnostic portfolio provides the golden standard of molecular based immunoassay technology for liver surveillance, cutting-edge clinical diagnostic chemicals for leading laboratories across the country, and diagnostic chemicals for OEM white labeling products.

Job Summary

This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation.

The successful candidate will support full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all other applicable laws, regulations, and standards.

Key Responsibilities

  • Designated Responsible Personnel for Device Marketing Authorization and Facility Registration to include proper registration, listing, licensing, notification, and approval information submission to regulatory authorities or authorized representative participating in the Medical Device Single Audit Program (MDSAP) (ISO 13485/MDSAP)
  • Designated Joint Responsibility pursuant of Article 15 of the European Union Medical Device Regulation (EU MDR (EU) No. 2017/745)
  • Perform Pre-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan
  • Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device
  • Prepare European Union Technical Files and International Regulatory Submissions
  • Coordinate Import/Export/Customs activities
  • Evaluate all sources of incoming customer information, identify, investigate, and document Customer Complaints, perform trend analysis, and maintain all records
  • Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action, and maintain all records
  • Coordinate all Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals, take appropriate action, and maintain all records
  • Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs, and Sales to facilitate required action
  • Perform Corrective and Preventive Action activities
  • Prepare documentation for remediation activities
  • Prepare Management Review Meeting presentations
  • Attend all department and company-wide team meetings as needed
  • Other duties as assigned
  • Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all other applicable laws, regulations, and standards

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 (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations
  • Broad knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive, and Canada Medical Device Regulations)
  • 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 (both internal and external)
  • Excellent computer and internet search skills
  • Strong ability to multi-task and to meet business deadlines
  • Excellent organizational skills with an ability to think proactively and prioritize work

Physical Requirements

The position requires the ability to perform the following physical demands and/or have the listed capabilities:

  • 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.

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.