Regulatory Affairs Manager

Job not on LinkedIn

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Hyland

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🤝 B2B

☁️ SaaS

🏢 Enterprise

B2B • SaaS • Enterprise

Hyland is a company that provides a collaborative community platform for its customers and partners, offering access to resources such as products, solutions, and updates. The platform enables users to share feedback, ask questions, and connect with each other, fostering operational knowledge and organizational value. Hyland Community aims to enhance user experience by facilitating interaction between experts and community members.

📋 Description

• Assist in establishing and maintaining quality management systems • Ensure organization members are aware of the quality system • Support employee compliance with international, federal, state, and organizational requirements • Track employee training, new-hire training, and certification status • Maintain and organize regulatory documentation, submissions, correspondence, and tracking databases • Liaise between the company and regulatory agencies and facilitate timely responses • Ensure compliance with document, record, and change-control procedures • Maintain archives of change requests and new or revised documents, including policies, procedures, work instructions, design and development documentation, and technical files • Prepare documentation for internal audits and track materials provided to auditors • Monitor corrective and preventive action programs from identification through closure • Collaborate with regulatory affairs teams to align training programs with regulatory expectations • Research, interpret, and monitor current and emerging industry regulations and standards

🎯 Requirements

• Bachelor's degree or equivalent experience • 2 years of relevant experience • Microsoft Windows and Office proficiency • Knowledge of FDA QSR, ISO 13485:2016, MDD, and CMDCAS • Good oral and written communication skills • Organizational, multitasking, and time management skills • Collaboration skills • Microsoft Excel skills • Facilitation and project management skills • Interpersonal skills and ability to maintain professionalism • Data gathering, interviewing, and analytical/problem-solving skills • Critical thinking and problem-solving skills • Ability to translate goals into implementation of new ideas and design solutions • Self-motivated, with ability to manage projects to completion with oversight • Ability to thrive in a fast-paced, deadline-driven environment • Attention to detail • Ability to influence, motivate, and mobilize team members and business partners • Ability to develop engaging, informative, and compelling presentations • Ability to handle sensitive information with discretion and tact • Ability to establish rapport, gain trust, and achieve consensus • Ability to work independently and in a team environment • Ability to understand federal, state, and international regulations and laws concerning medical devices • Knowledge of systems administration • Knowledge of industry-standard compliance principles and best practices • Understanding of core company products and technologies

🏖️ Benefits

• Up to 5% travel time required