Jobs
>
Penicuik

    Regulatory Affairs Officer - Penicuik, Midlothian, United Kingdom - ESS Recruit

    ESS Recruit
    ESS Recruit Penicuik, Midlothian, United Kingdom

    3 weeks ago

    Default job background
    Description

    REGULATORY AFFAIRS OFFICER



    BIOTECHNOLOGY LIFE SCIENCES MEDICAL DEVICES OR PHARMACEUTICALS
    BASED EDINBURGH – SALARY EXCELLENT PLUS BENEFITS / HYBRID WORKING

    Based in Edinburgh, ESS's client is a well-established bio-manufacturing organisation, with an internationally recognised product portfolio. The product range includes in vitro diagnostics and medical devices for use in clinical laboratories throughout the world.

    The organisation also offers contract services to the bioscience industry and currently manufactures products for major global players in the Life Sciences sectors.


    They are recruiting for a Regulatory Affairs Officer to join their Regulatory Affairs & Quality team; the role is a full permanent position working flexible working hours and with hybrid working.

    You will be responsible for building regulatory strategy, applicable regulatory requirements, solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.

    Responsibilities:

    Prepare, write and compile regulatory documentation, coordinate and execute regulatory submission with FDA, European Notified Bodies, Health Canada etc.
    Review analytical data from development studies and performance evaluation studies

    Advise staff / project team members on data and information required for successful license applications and co-ordinate efforts to ensure the standard for submission.

    Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs) Biologics License Applications (BLA), Medical Device Approvals (510(k), Canadian Medical Device Regulations (CMDR) etc.

    Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information;

    Actively participate in product development projects in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation.

    Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities;

    Assist with the implementation of the Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), 13485 standards the 98/79/EC IVD Directive, IVD 2017/746 Regulation, FDA Regulations, Health Canada Medical Device Regulation etc.

    You should hold a relevant degree and/or have work experience in a Regulatory Affairs environment; with the ability to prepare coherent regulatory reports and filings; sound knowledge and expertise with core IT packages.

    You will need to handle external communication with staff from regulatory bodies, customers, distributors and labelling and packaging suppliers and be proactive and able to work effectively both independently or within a team, participating in R&D project teams as required and deliver end results.


    This is an excellent chance to join a thriving and highly successful expanding Scottish business, part of a much larger UK based blue chip business, launching new products and a medical device and volume manufactured consumable.

    A competitive basic salary is on offer with a comprehensive benefits package including company pension, healthcare and company bonus. To apply for this role please contact Katie Hydes at ESS Recruit
  • Technical Services

    Regulatory Affairs Officer

    3 days ago

    Technical Services Penicuik, United Kingdom

    Alba Bioscience Limited · At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba-- our ...

  • AliveDx

    Senior Regulatory Affairs Officer

    2 days ago

    AliveDx Penicuik, United Kingdom

    At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba-- our blood bank reagents portf ...

  • LHH Recruitment Solutions

    Public Affairs and Communications Officer

    2 weeks ago

    LHH Recruitment Solutions Edinburgh, United Kingdom

    £28,000 - £30,000 · Permanent · Remote (Scotland) · LHH Recruitment is delighted to be supporting our client, professional association, as they seek to recruit a Public Affairs and Communications Officer. · Reporting to the Director of Communications, the main purpose of the role ...

  • LHH Recruitment Solutions

    Public Affairs and Communications Officer

    2 weeks ago

    LHH Recruitment Solutions Edinburgh, United Kingdom

    **Public Affairs and Communications Officer (Scotland)** · **£28,000 - £30,000** · **Permanent** · **Remote (Scotland)** · LHH Recruitment is delighted to be supporting our client, professional association, as they seek to recruit a Public Affairs and Communications Officer. · Re ...

  • LHH Recruitment Solutions

    Public Affairs and Communications Officer

    2 weeks ago

    LHH Recruitment Solutions Edinburgh, United Kingdom

    £28,000 - £32,000 · Permanent · Remote (Scotland) · LHH Recruitment is delighted to be supporting our client, professional association, as they seek to recruit a Public Affairs and Communications Officer. · Reporting to the Director of Communications, the main purpose of the role ...

  • RICS

    Senior Public Affairs Officer

    2 weeks ago

    RICS Edinburgh, United Kingdom

    **Senior Public Affairs Officer (Scotland)** · **Location**: Hybrid - Remote with travel to RICS Edinburgh office as and when required · **Job type**: Permanent · **Salary**: £40,000 to £45,000 DOE · **Job Purpose** · To deliver and win market demand for RICS professionalism in t ...

  • The British Association of Social Workers

    Communications and Public Affairs Officer

    4 days ago

    The British Association of Social Workers Edinburgh, United Kingdom

    The **Scottish Association for Social Work **(part of BASW) is looking for an **experienced communications and public affairs professional **to take our **influence** and **impact** in the **public sphere **to the next level. · This role offers you opportunity to work with **poli ...

  • Isaac Gracie

    Senior Regulatory Affairs Officer

    2 weeks ago

    Isaac Gracie Cumbernauld, United Kingdom

    **Senior Regulatory Affairs Officer** · **Salary - £45,000** · Our client is an international aesthetics market leader, boasting over 30 years industry experience. Innovation and continuous improvement rank high as their key drivers when manufacturing the product portfolio. A fan ...

  • GC Aesthetics

    Senior Regulatory Affairs Officer

    3 weeks ago

    GC Aesthetics Cumbernauld, United Kingdom

    **Division**:GC Aesthetics - Nagor, UK · **Location**: Cumbernauld, UK or Remote · **Job Title**:Senior** **Regulatory Affairs Officer · **Department**: Regulatory · **Responsible to**:Regulatory Affairs Manager · **Purpose of Job (Summary)** · This role within the Regulatory tea ...

  • Cpl Life Sciences

    Regulatory Affairs Officer

    3 days ago

    Cpl Life Sciences Dalkeith, Midlothian, United Kingdom

    Job Title: Regulatory Affairs Officer · Job Type: Full-time, permanent position · Location: Outskirts of Edinburgh, Scotland, UK · Remuneration: £35,000 to £37,000 + benefits · An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regu ...

  • Cpl Life Sciences

    Regulatory Affairs Officer

    1 day ago

    Cpl Life Sciences Edinburgh, United Kingdom

    Job Title: Regulatory Affairs Officer · Job Type: Full-time, permanent position · Location: Outskirts of Edinburgh, Scotland, UK · Remuneration: £35,000 to £37,000 + benefits · An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regul ...

  • Cpl

    Regulatory Affairs Officer

    3 days ago

    Cpl Edinburgh, United Kingdom Full time

    Job Title: Regulatory Affairs Officer · Job Type: Full-time, permanent position · Location: Outskirts of Edinburgh, Scotland, UK · Remuneration: £35,000 to £37,000 + benefits · An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regu ...

  • Cpl Life Sciences

    Regulatory Affairs Compliance Officer

    3 days ago

    Cpl Life Sciences Dalkeith, Midlothian, United Kingdom

    Job Title: Regulatory Affairs Officer · Job Type: Full-time, permanent position · An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. In this role as a Regulatory Affairs Officer, you will be responsib ...

  • Red Personnel

    Policy and Public Affairs Manager

    2 weeks ago

    Red Personnel Bonnyrigg, United Kingdom Full time

    Policy and Public Affairs Manager (Scotland) · Sector : Professional Membership · Permanent Opportunity · Salary: £40,318-£44,748 per annum plus benefits · Location: Edinburgh (Scotland) · Overview · We are seeking a dynamic individual who can blend exceptional campaign, analytic ...

  • Blue Arrow - Edinburgh

    Research and Marketing Administrator

    2 weeks ago

    Blue Arrow - Edinburgh Bonnyrigg, United Kingdom Full time

    Blue Arrow Edinburgh are currently recruiting for a Research and Marketing Administrator · Job description · The duties required of the office assistant will primarily consist of administrative support of the office, assisting the Trade Team with inbound queries from regional b ...

  • Clinical Professionals

    Senior Regulatory Associate

    3 weeks ago

    Clinical Professionals Edinburgh, United Kingdom

    **Reference Number: JO ** · Senior Regulatory Associate · Rate: Negotiable · **Job Type**: Permanent · Location: Edinburgh · **Job Title**:Regulatory Affairs Officer/ Senior Officer · **Location**:Near Edinburgh, Scotland, UK · **Remuneration**: Attractive salary and package · An ...

  • Scottish Grocer Federation

    Public Affairs Assistant

    3 weeks ago

    Scottish Grocer Federation Edinburgh, United Kingdom

    **Your New Company** · Hays are delighted to be exclusively partnered with The Scottish Grocers' Federation (SGF) to support in the recruitment of a Public Affairs Assistant to join their team based in Edinburgh. The SGF is the national trade body for the convenience store sector ...

  • Intergen

    Regulation and Public Affairs Senior Associate

    1 week ago

    Intergen Edinburgh, United Kingdom

    **Edinburgh, Scotland, United Kingdom**: · **The Role**: · We are investing in several new positions to our business and have an exciting opportunity for a Regulation & Public Affairs Senior Associate to join our dynamic team As a leading voice in our industry, we're looking for ...

  • Royal College of Physicians

    Rcpe Intern: Policy

    2 weeks ago

    Royal College of Physicians Edinburgh, United Kingdom

    **Vacancy: RCPE Intern: Policy and Public Affairs** · **Salary: £11.44 per hour** · **Location: Edinburgh/Hybrid** · **Fixed term contract, 35 hours per week, up to 10 or 12 weeks over summer 2024** · **About the Royal College of Physicians of Edinburgh** · The College is an inde ...

  • Royal Pharmaceutical Society

    Policy and Practice Lead- Scotland

    2 weeks ago

    Royal Pharmaceutical Society Edinburgh, United Kingdom

    Come join the Royal Pharmaceutical Society (RPS) as our Policy and Practice Lead. You will support the strategic leadership of the RPS Scotland Directorate and the RPS Scottish Pharmacy Board by leading on policy development and professional support in Scotland. · You will work a ...