Jobs
>
London

    Regulatory Affairs Supervisor - United Kingdom - Edinburgh City Football Club Limited.

    Edinburgh City Football Club Limited.
    Edinburgh City Football Club Limited. United Kingdom

    3 weeks ago

    Default job background
    Description

    Regulatory Affairs Supervisor

    Location: Littleport, Cambridgeshire - CB6 1SE Salary: £45k + Benefits Contract: Full time, Permanent Hours: 37.5 pw

    Benefits:


    • 25 days holiday a year plus bank holidays, increases with length of service
    • Company pension scheme, minimum 4% contribution
    • Private healthcare after successful completion of the probationary period
    • Death in service - 4x salary
    • Enhanced Sick pay scheme
    • Free fruit each day
    • On-site Parking
    • Company events

    Overall Job Purpose:

    To manage the Regulatory Affairs (RA) function in Omega Diagnostics to ensure it performs to a level that allows the organisation to meet all its regulatory responsibilities.HR Coordinator - Job Purpose:

    Regulatory Affairs Supervisor - Main Areas of Responsibility:


    • Lead by example and demonstrate consistent, good HR practice and people management.
    • Motivate the team to achieve potential through PDR's, regular 1:1's, and training or development. Manage day-to-dayRegulatory Affairs activities providing guidance and support to the Omega Diagnostics Regulatory Affairs team.
    • Planning, coordination, and management of regulatory documentation activities.
    • Review and compilation of Medical Device Files (such as Technical Files, DHF) for Omega Diagnostics products toensure adequate compliance with regulations.
    • Preparation of documentation in support of regulatory function, i.e., post-market surveillance reports, riskmanagement plans/reports, and others, as required.
    • Preparation of documentation in support of Omega Diagnostics regulatory submissions to comply with regulatoryauthorities for registrations of products worldwide to gain marketing authorization.
    • Notification to regulatory authorities, where applicable, of significant product changes to retain marketing authorization.
    • To liaise with partners and regulatory authorities to support regulatory submissions and vigilance activities.
    • Review and approve product labelling, including instructions for use, container labels, packaging artwork, promotionaland training material for Omega Diagnostics products, as required.
    • Review and approval of product development verification protocols and reports.
    • Implementation and maintenance of a UDI system.
    • Maintenance of Regulatory procedures to ensure continued compliance.
    • Responsible for post-market surveillance activities.
    • To ensure regulatory processes are followed and within required timeframes.
    • Supporting internal and external audits to represent Regulatory Affairs positions and processes.
    • Assess changes in regulations and determine their impact.
    • Lead, mentor, and train team members as required.
    • To be involved in ODL's areas of cGMP and continual improvement in all aspects of the QMS.

    Regulatory Affairs Supervisor - Knowledge, Qualifications & Skills:

    Essential:


    • Knowledge of regulatory submission requirements for medical devices or IVDs in EU and MDSAP Countries (Canada, Brazil, Australia, USA)
    • 5 year's experience in a regulatory position or professional qualification in Regulatory Affairs.

    Desired:


    • Supervisory experience
    • Familiarity with IVD regulations
    • Broader global regulatory requirements

    Our core values:


    • Customer Focus: customer satisfaction is not a department, everyone is responsible; listening to customers drives improvement
    • Accountability: ask "what more can I do"; takes ownership
    • Collaboration: actively support your colleagues; be clear in communication; celebrate success and have fun together
    • Respect: treat others as we would wish to be treated; respect the environment we work and live in
    • Honesty: aspire to be open and transparent; take pride in building trust between ourselves and others

    Due to the volume of applications, we are unable to respond to all applications. If you do not hear from us in four weeks, please assume that your application has been unsuccessful.

    If you feel you have the necessary skills and experience to be successful in this role, click on "APPLY" today, forwarding an up-to-date copy of your CV together with a covering letter explaining how you meet the essential criteria.

    No agencies please.

    #J-18808-Ljbffr
  • Willis Towers Watson

    Regulatory Affairs Supervisor

    1 day ago

    Willis Towers Watson London, United Kingdom

    To support our growing team, we are looking for an experienced T&C Supervisor, who can also lead our internal quality initiatives (our "Excellence" process), alongside supporting the Financial Planning and Defined Contribution (DC) Consulting teams with routine compliance matters ...

  • AJ Chambers

    Accounts Supervisor

    3 weeks ago

    AJ Chambers London, United Kingdom

    **ACCOUNTS SUPERVISOR - MEDIA AND ENTERTAINMENT CLIENTS** · A great opportunity for a Supervisor or experienced Senior to join a growing accountancy firm in London, working solely with clients in the media and entertainment sector. · The firm work with some of the biggest worldwi ...

  • Rutherford Briant

    Accounts Supervisor

    1 week ago

    Rutherford Briant London, United Kingdom

    Are you ACCA/ACA Qualified and fancy working with a portfolio of premium clients from the Media and Entertainment industry? · A reputable practice have built a formidable reputation within their specialist industry and due to this, they are growing and need a Supervisor to join t ...

  • Athora

    Senior Associate, Regulatory Relations

    2 weeks ago

    Athora London, United Kingdom

    This is a key role supporting the Group Head of Corporate Governance with the management of regulatory affairs at Athora. You will be responsible for supporting the development, implementation and reporting regarding the strategies to ensure that Athora has a proactive, construct ...

  • AJ Chambers

    Assistant Manager Music

    1 week ago

    AJ Chambers London, United Kingdom

    **Assistant Manager | Music & Entertainment clients** · Are you on the lookout for a new role as an Assistant Manager? With a range of music and entertainment clients? Then this is the role for you · We are working with a London based accountancy practice that work with well know ...

  • The Legists

    Legal Counsel

    3 weeks ago

    The Legists London, United Kingdom

    **DIRECTOR, MUSIC BUSINESS AFFAIRS - EMEA** · **GLOBAL MEDIA BUSINESS** · **LONDON / HYBRID WORKING** · We have a senior role for an experienced music lawyer. You will work for one of the most prestigious TV, Film and Streaming platforms in the world. · The position sits within t ...

  • Butler Rose Ltd

    Accounts Supervisor

    2 weeks ago

    Butler Rose Ltd London, United Kingdom

    City of London (Hybrid) · £55,000 to £65,000 (DOE) · Butler Rose public practice are delighted to be supporting our client, a dynamic and high growth leading professional services group with a history dating to 1888, that are now eager to appoint a qualified and suitably experien ...

  • Rutherford Briant

    Accounts Assistant Manager

    1 week ago

    Rutherford Briant London, United Kingdom

    Want the chance to work with some of the biggest worldwide names in the film, television and fashion industries? · A reputable practice have built a formidable reputation within their specialist industry and due to this, they are growing and need an Accounts Assistant Manager to ...

  • Tradewind Recruitment

    Cover Supervisor

    3 weeks ago

    Tradewind Recruitment London, United Kingdom

    Have you got valuable experience in schools that you can bring to this role, and help maintain the high standards with student engagement at the heart of what they do? · **_This excellent Harrow school are looking for a Cover Supervisor who can provide support to their ambitious ...

  • Redwood Publishing

    Editorial Supervisor

    2 weeks ago

    Redwood Publishing London, United Kingdom

    Editorial Supervisor · REF: ES250124 · SALARY: £40K-£46K · LOCATION**:LONDON** OR **OXFORD** - HYBRID - 1 DAY A WEEK IN OFFICE · Redwood is excited to be partnering with a leading, global economics and finance Consultancy who have a wonderful opportunity to join them as their Edi ...

  • MSCI Inc

    Policy Specialist

    2 weeks ago

    MSCI Inc London, United Kingdom

    Job Description - Policy Specialist - Government and Regulatory Affairs B3) · - Job Number: 240000B3 · Requisition Title : Policy Specialist - Government and Regulatory Affairs · **Description**: · **Your team responsibilities** · MSCI is driven to innovate and provide industry-l ...

  • Taylor Hawkes Ltd

    Accounts Supervisor

    2 weeks ago

    Taylor Hawkes Ltd London, United Kingdom

    Overview · Our client is an independent firm of chartered accountants, based in central London. Due to their rapid growth, they are looking for an Accounts Supervisorto support their management teamwith managing a small portfolio of clients. · About the role · This role would sui ...

  • Hanbury Strategy

    Eu Digital Policy Consultant

    1 week ago

    Hanbury Strategy London, United Kingdom

    **Job Title**:EU Digital Policy Consultant · **Working For**:Hanbury Strategy · **Location**: Brussels or London · **Salary**:Competitive and dependant on experience · **EU Digital Policy Consultant - Hanbury Strategy** · **About Hanbury Strategy** · Hanbury Strategy is a strateg ...

  • HYF

    Document Production Supervisor

    2 weeks ago

    HYF London, United Kingdom Full time

    Document Production Supervisor · Fully remote working · Friday, Saturday, Sunday 9am – 6pm and Monday 9am -5pm · £60,000 - £64,000. · Large global law firm are currently recruiting for an experienced Legal Document Production Supervisor to join their in-house document production ...

  • The Associated Press

    Videojournalist (Global News Intern, Output

    1 week ago

    The Associated Press London, United Kingdom

    The Associated Press seeks talented, ambitious and diverse college students and recent graduates from around the world for its 2024 news internship program, with paid positions available in the U.S. and internationally. Applicants may express interest in one or more positions. Al ...

  • Hanbury Strategy

    Eu Digital Policy Consultant

    1 week ago

    Hanbury Strategy London, United Kingdom

    **Job Title**:EU Digital Policy Consultant · **Working For**:Hanbury Strategy · **Location**: Brussels or London · **Salary**:Competitive and dependant on experience · **EU Digital Policy Consultant - Hanbury Strategy** · **About Hanbury Strategy** · Hanbury Strategy is a strateg ...

  • Australian High Commission

    Reception/security Guard

    2 weeks ago

    Australian High Commission London, United Kingdom

    **Contract**:12 Months Fixed Term · **Full-Time**:40 hours per week · **Salary**:£27, £29,147 per annum · The Australian High Commission, London is looking for a Security Guard to complete day shifts at Australia House during normal office hours. The normal shift pattern will be ...

  • Australian High Commission

    Reception/security Guard

    3 weeks ago

    Australian High Commission London, United Kingdom

    **Contract**:12 Months Fixed Term · **Full-Time**:40 hours per week · **Salary**:£27, £29,147 per annum · The Australian High Commission, London is looking for a Security Guard to complete day shifts at Australia House during normal office hours. The normal shift pattern will be ...

  • The Associated Press

    Newsperson (Global News Intern, Sports)

    1 week ago

    The Associated Press London, United Kingdom

    The Associated Press seeks talented, ambitious and diverse college students and recent graduates from around the world for its 2024 news internship program, with paid positions available in the U.S. and internationally. Applicants may express interest in one or more positions. Al ...

  • Warner Bros. Discovery

    Cnn - Producer, Isa Soares Tonight (Fixed Term

    1 week ago

    Warner Bros. Discovery London, United Kingdom

    **_Every great story has a new beginning, and yours starts here._** · **_ Welcome to Warner Bros. Discoverythe stuff dreams are made of._** · **Who We Are ** · When we say, "the stuff dreams are made of," we're not just referring to the world of wizards, dragons and superheroes, ...