Overview

Manager, Regulatory Affairs

📍 United Kingdom | 💻 Remote

About the Role

The Manager, Regulatory Affairs assists in establishing and maintaining quality management systems while ensuring all members of the organization are aware of and compliant with applicable quality standards. In this role, you will support employee compliance with all international, federal, state, and organizational requirements, act as a key liaison with regulatory agencies, and maintain critical documentation that underpins the company's regulatory posture. If you're a detail-oriented regulatory professional who thrives in a dynamic, compliance-focused environment, this role is for you.

Technology Tools

• Microsoft Windows & Office Suite
• Microsoft Excel (Advanced)
• Regulatory Tracking Databases & Document Management Systems

Your Role Responsibilities — Here's What You'll Do

• Perform activities and maintain systems for tracking employee training, new hire training, and certification status to comply with federal, state, and international regulatory agencies.
• Maintain and organize regulatory documentation including job descriptions, resumes, regulatory submissions, correspondence with regulatory agencies, and regulatory tracking databases.
• Act as a liaison between the company and regulatory agencies, facilitating communication and ensuring timely, accurate responses to inquiries.
• Ensure compliance with document, record, and change control procedures, including adhering to document and part numbering protocols; maintain an archive of all change requests and individual documents for both new and revised documents.
• Prepare documentation requested in support of internal audits; track what has been provided to auditors and monitor a log of corrective and preventive action programs from point of identification to closure.
• Research, interpret, and stay abreast of current and emerging regulations and standards in the industry; collaborate with regulatory affairs teams to ensure alignment of training programs with current regulatory expectations.

Role Essentials — What You Bring

• Bachelor's degree or equivalent experience, with 2 years of relevant experience and knowledge of FDA QSR, ISO 13485:2016, MDD, and CMDCAS.
• Proficiency with Microsoft Windows and Office suite, including strong Microsoft Excel skills, with good knowledge of regulatory tracking databases and systems administration.
• Good oral and written communication skills that reflect a professional demeanor, with the ability to interact with others with discretion and tact, and good interpersonal and collaboration skills applied successfully within teams and across areas.
• Good organizational, multi-tasking, and time management skills, with strong data gathering, analytical, and problem-solving skills and the ability to thrive in a fast-paced, deadline-driven environment.
• Good knowledge of industry-standard compliance principles and best practices, with the ability to understand federal, state, and international regulations and laws concerning medical devices, with up to 5% travel time required.

What We'd Like to See — Preferred Skills

• Demonstrated experience maintaining regulatory documentation systems and archives, including policies, procedures, work instructions, design and development documentation, and technical files.
• Experience acting as a liaison between a company and regulatory agencies, with a proven ability to facilitate communication and ensure timely, accurate responses to regulatory inquiries.
• Experience monitoring corrective and preventive action (CAPA) programs from identification to closure, with strong attention to detail and a commitment to regulatory compliance.
• Demonstrated ability to research, interpret, and stay current on emerging regulations and standards, with experience collaborating with regulatory affairs teams to align training programs with current regulatory expectations.
• Self-motivated with the ability to manage projects to completion with oversight, with a good ability to influence, motivate, and mobilize team members and business partners toward shared compliance goals.

About Hyland

Hyland is the pioneer of the Content Innovation Cloud™, delivering ubiquitous enterprise intelligence to organizations with solutions that unlock actionable insights and drive automation.

Trusted by thousands of organizations worldwide, including many of the Fortune 100, Hyland's solutions create the foundation for a connected, agentic enterprise, where teams harness the power of AI to redefine how they operate and engage with those they serve. For additional information on Hyland's platform and services, please visit Hyland.com.

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About Hyland Life

#HylandLife

Since 1991, it has been Hyland's mission to help our employees, customers and partners exceed their potential with our industry-leading content services platform. Our employees exude a contagious energy and are passionate about what they do – whether it's helping customers succeed, raising up their fellow Hylanders, or engaging in the communities where they live and work.

The #HylandLife hashtag encompasses our employee-centric culture. Our employees live our culture day in and day out by bringing their best self to work. Hyland supports them to do just that through career development resources, wellbeing programs and innovation practices. We thrive on diverse viewpoints and new ideas and believe that a positive, inclusive workplace is imperative to sustainable success.

As we've grown to a company of nearly 4,000 strong, we have the opportunity to make a significant impact on our communities. We strongly support employee initiatives and align our giving campaigns and programs to organizations that are important to them.

Equal Opportunity Statement

Hyland is an equal opportunity employer. We value diversity and are committed to providing an inclusive workplace for all employees and applicants. Employment decisions are made without regard to any characteristic protected by applicable laws and regulations. Information collected during the hiring process is used solely to assess qualifications, verify identity, and comply with legal requirements.