Regulatory Affairs Officer

3 weeks ago

Penicuik Midlothian, United Kingdom ESS Recruit Full time

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. #J-18808-Ljbffr

  • Regulatory Affairs Officer

    4 weeks ago

    Penicuik, United Kingdom Technical Services Full time

    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 blood bank reagents portfolio-- and MosaiQ®-- one of the first multiplexing and...

  • Senior Regulatory Affairs Officer

    4 weeks ago

    Penicuik, United Kingdom AliveDx Full time

    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 portfolio-- and MosaiQ®-- one of the first multiplexing and multimodality automated...

  • Regulatory Affairs Officer

    2 days ago

    Dalkeith, Midlothian, United Kingdom Cpl Life Sciences 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 Regulatory Affairs Department. In this role as a Regulatory Affairs Officer, you will be...

  • Regulatory Affairs Officer

    2 days ago

    Dalkeith, Midlothian, United Kingdom Cpl Life Sciences 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 Regulatory Affairs Department. In this role as a Regulatory Affairs Officer, you will be...

  • Regulatory Affairs Officer

    2 days ago

    Dalkeith, Midlothian, United Kingdom Cpl Life Sciences Full time

    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 responsible for building regulatory strategy, determining applicable regulatory...

  • Regulatory Affairs Officer

    2 days ago

    Dalkeith, Midlothian, United Kingdom Cpl Life Sciences Full time

    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 responsible for building regulatory strategy, determining applicable regulatory...

  • Senior RA

    2 months ago

    Penicuik, Midlothian, United Kingdom Stem Recruitment Full time

    Stem Recruitment have a couple of opportunities for experienced RA & Senior RA's based near Edinburgh for a medical device company. The roles are responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the...

  • Senior RA

    1 week ago

    Penicuik, Midlothian, United Kingdom Stem Recruitment Full time

    Stem Recruitment have a couple of opportunities for experienced RA & Senior RA's based near Edinburgh for a medical device company. The roles are responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the...

  • Senior RA

    2 months ago

    Penicuik, Midlothian, United Kingdom Stem Recruitment Full time

    Stem Recruitment have a couple of opportunities for experienced RA & Senior RA's based near Edinburgh for a medical device company. The roles are responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the...

  • Senior RA

    1 week ago

    Penicuik, Midlothian, United Kingdom Stem Recruitment Full time

    Stem Recruitment have a couple of opportunities for experienced RA & Senior RA's based near Edinburgh for a medical device company. The roles are responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the...

  • Senior RA

    1 week ago

    Penicuik, United Kingdom Stem Recruitment Full time

    Stem Recruitment have a couple of opportunities for experienced RA & Senior RA's based near Edinburgh for a medical device company.The roles are responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate...

  • Senior RA

    1 month ago

    Penicuik, United Kingdom Stem Recruitment Full time

    Stem Recruitment have a couple of opportunities for experienced RA & Senior RA's based near Edinburgh for a medical device company.The roles are responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate...

  • Senior RA

    2 months ago

    Penicuik, United Kingdom Stem Recruitment Full time

    Stem Recruitment have a couple of opportunities for experienced RA & Senior RA's based near Edinburgh for a medical device company. The roles are responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the...

  • Interim Policy

    1 week ago

    Dalkeith, Midlothian, United Kingdom Red Personnel Full time €40,318 - €44,748

    Policy and Public Affairs Manager (Scotland) Permanent Opportunity We are seeking a dynamic individual who can blend exceptional campaign, analytical, and policy development skills with strong interpersonal abilities to effectively communicate the Scotland's perspectives on a diverse range of complex policy areas. In collaboration with the National Manager,...

  • Interim Policy

    2 weeks ago

    Dalkeith, Midlothian, United Kingdom Red Personnel Full time

    Policy and Public Affairs Manager (Scotland) Permanent Opportunity We are seeking a dynamic individual who can blend exceptional campaign, analytical, and policy development skills with strong interpersonal abilities to effectively communicate the Scotland's perspectives on a diverse range of complex policy areas. In collaboration with the National Manager,...

  • Quality & Risk Coordinator

    2 days ago

    Penicuik, United Kingdom Quotient Full time

    Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to...

  • Communications Officer Devolved Nations

    5 days ago

    Dalkeith, Midlothian, United Kingdom NFP People Full time €27,570

    Communications Officer Devolved Nations We are looking for a Communications Officer to support the team in Scotland to respond to Scottish media enquiries, delivering campaigns to influence health policy and support the fundraising and engagement comms activity. This is a remote working role and applications from individuals who are seeking flexible working...

  • Communications Officer Devolved Nations

    6 days ago

    Dalkeith, Midlothian, United Kingdom NFP People Full time €27,570

    Communications Officer Devolved Nations We are looking for a Communications Officer to support the team in Scotland to respond to Scottish media enquiries, delivering campaigns to influence health policy and support the fundraising and engagement comms activity. This is a remote working role and applications from individuals who are seeking flexible working...

  • Senior Manager, Data

    3 weeks ago

    Dalkeith, Midlothian, United Kingdom Anderson Anderson & Brown LLP Full time

    THE BUSINESS AAB is a tech-enabled business critical services group providing audit and accounting, tax, payroll and HR, outsourcing and advisory solutions globally from offices in Aberdeen, Edinburgh, Glasgow, Leeds, London and the island of Ireland. We help our clients manage the critical elements of their business - its people and its finances - by...

  • Senior Manager, Data

    3 weeks ago

    Dalkeith, Midlothian, United Kingdom Anderson Anderson & Brown LLP Full time

    THE BUSINESS AAB is a tech-enabled business critical services group providing audit and accounting, tax, payroll and HR, outsourcing and advisory solutions globally from offices in Aberdeen, Edinburgh, Glasgow, Leeds, London and the island of Ireland. We help our clients manage the critical elements of their business - its people and its finances - by...