Regulatory Affairs Specialist

Fujifilm Corporation
Stockton-on-Tees
8 months ago
Applications closed

Related Jobs

View all jobs

Regulatory Affairs Specialist - RIMS

Senior Consultant Biocide Regulatory Specialist

Regulatory Submissions Manager

Medical Information Specialist (German Speaking)

Medical Imaging Specialist

Life Science ­Principal Recruitment Consultant x2 - London

Overview

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. Fujifilm’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. The company is headquartered in Lexington, Massachusetts. For more information, please visit .

External US

Job Title: Regulatory Affairs Specialist

Job purpose

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

Duties and 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.

Qualifications 

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed

Software Powered by iCIMS

Get the latest insights and jobs direct. Sign up for our newsletter.

By subscribing you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Negotiating Your Biotech Job Offer: Equity, Bonuses & Perks Explained

How to Secure a Compensation Package That Reflects Your True Value in the UK’s Thriving Life Sciences Sector Introduction Biotechnology is one of the most dynamic and impactful sectors in today’s global economy—particularly in the UK, which boasts a thriving research ecosystem and a burgeoning community of innovative start-ups. From cutting-edge work on gene editing and CAR-T therapy to breakthroughs in diagnostics and personalised medicine, the biotech field promises vast opportunities for mid‑senior professionals to make a meaningful difference. However, with these opportunities comes the need for careful negotiation when evaluating a new role. Biotech companies—whether they’re large pharmaceutical giants or lean start-ups—often structure compensation packages that go far beyond simple salaries. These may include equity grants, performance-based bonuses, and a range of perks designed to attract top talent in a competitive market. Focusing solely on your base salary could mean missing out on substantial long-term rewards or lifestyle benefits. In biotech, your contributions might directly influence life-changing products, high-stakes clinical trials, or novel therapeutic approaches. Hence, your compensation should reflect both the immediate and future value you bring. This article aims to be your comprehensive guide to negotiating a biotech job offer in the UK. We’ll delve into why negotiation goes beyond salary, how equity functions in the biotech context, and how performance bonuses and other perks can amplify the overall value of your compensation. Geared for mid‑senior professionals, this guide offers actionable insights to help you secure a holistic compensation package that aligns with your expertise, future goals, and the impact you will have on advancing life sciences.

Biotech Jobs in the Public Sector: Where to Find Meaningful Careers Across the NHS, Research Councils, and Beyond

Biotechnology has become one of the most vibrant and impactful fields of the 21st century, transforming everything from healthcare and pharmaceuticals to agriculture and environmental conservation. In the UK, the public sector is at the forefront of many biotech initiatives, supported by world-class research institutions, government bodies, and large-scale healthcare networks such as the National Health Service (NHS). For professionals seeking purpose-driven work, biotech jobs in the public sector present a compelling opportunity to blend scientific innovation with a meaningful impact on society. Whether you aspire to develop cutting-edge therapies for chronic diseases, optimise food production in a sustainable way, or champion environmental conservation, the public sector’s broad remit means there are numerous pathways to explore. In this article, we’ll delve into the biotech jobs landscape within the UK public sector—shedding light on why biotechnology is crucial for government bodies, which organisations are leading the charge, and the types of roles available. We’ll also discuss the skills needed to excel in these positions, potential salary ranges, and how to successfully apply. By the end, you’ll have a clearer picture of how you can leverage your biotech expertise to serve the nation through a public sector career.

Contract vs Permanent Biotech Jobs: Which Pays Better in 2025?

In the ever-advancing world of life sciences, biotechnology has emerged as one of the fastest-growing and most impactful sectors in the UK. From gene editing and regenerative medicine to synthetic biology and vaccine development, British biotech organisations are at the forefront of scientific innovation. With this growth comes a high demand for skilled professionals—scientists, data analysts, regulatory affairs specialists, bioprocess engineers, and more—who can help bring cutting-edge treatments and products to market. However, as the biotechnology landscape in the UK continues to expand, so too do the ways in which professionals choose to work. Beyond traditional permanent employment, many biotech specialists are exploring the world of contracting, which can take the form of day‑rate consulting or fixed-term contracts (FTC). Each path promises unique advantages and disadvantages, from pay rates and benefits packages to career development and job security. This article offers a comprehensive guide on contract vs. permanent biotech jobs in 2025. We will explore how the UK biotech sector is shaping up, break down the different types of employment arrangements, and present sample take‑home pay scenarios for each. Our goal is to empower you with the knowledge needed to make an informed decision that aligns with both your financial aspirations and long-term career goals within the vibrant and evolving biotech industry.