Regulatory Affairs Officer

4 weeks 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 responsible for building regulatory strategy, determining applicable

regulatory requirements, proposing solutions to comply with regulatory requirements, and managing product license registration with the appropriate regulatory authorities worldwide. Main responsibilities: ·

Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, 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) – Part 1 and other country requirements as appropriate. ·

Advise staff and project team members on data and information required for successful license applications and coordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission. ·

Develop product labelling regulatory requirements for products and for customer-contracted products including but not limited to package labels, product labels and instructions for use. ·

Liaise with internal and external parties as required to support the development of product labelling. ·

Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents and industry standards. ·

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). ·

Providing support to the Department Leader of Regulatory Affairs with regard to planning and co-ordination of activities and with regard to training and supervision of other members of the Regulatory Affairs team and to ensure continuous development

of junior staff to develop their capabilities. Requirements: ·

A relevant degree and/or relevant work experience in a regulatory affairs environment. ·

Experience in a medical device / IVD / biotech industry ·

Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, BPDR, MEDDEV 2.12, etc.) ·

Previous experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to other worldwide regulatory authorities. ·

Experienced in meeting with, making presentations to, and negotiating with regulators. ·

Ability to prepare coherent regulatory reports and filings. For more information please reach out to Please note this position does not offer sponsorship.

  • 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...


  • 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...


  • 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...


  • Dalkeith, Midlothian, United Kingdom Cpl Life Sciences Full time

    Job Title: Regulatory Affairs OfficerJob Type: Full-time, permanent positionLocation: Outskirts of Edinburgh, Scotland, UKRemuneration: £35,000 to £37,000 + benefitsAn 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...


  • 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 requirements,...

  • Interim Policy

    1 month 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,...

  • Interim Policy

    1 month 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,...

  • Senior Manager, Data

    3 weeks ago


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

    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 providing resources...


  • 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...


  • 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 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 month 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 month 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...


  • Dalkeith, Midlothian, United Kingdom Reed Full time

    Join Our Clients Team in Edinburgh: Your Opportunity to Shine in Financial Planning Administration! Are you ready to be the backbone of a thriving financial advisory service? Our client is seeking a meticulous and proactive  Financial Planning Administrator to join their Edinburgh office. Dive into a role where you are the face and voice of their...


  • Dalkeith, Midlothian, United Kingdom Reed Full time

    Join Our Clients Team in Edinburgh: Your Opportunity to Shine in Financial Planning Administration! Are you ready to be the backbone of a thriving financial advisory service? Our client is seeking a meticulous and proactive  Financial Planning Administrator to join their Edinburgh office. Dive into a role where you are the face and voice of their...


  • Dalkeith, Midlothian, United Kingdom Reed Full time

    Join Our Clients Team in Edinburgh: Your Opportunity to Shine in Financial Planning Administration! Are you ready to be the backbone of a thriving financial advisory service? Our client is seeking a meticulous and proactive Financial Planning Administrator to join their Edinburgh office. Dive into a role where you are the face and voice of their company,...


  • Dalkeith, Midlothian, United Kingdom Reed Full time

    Join Our Clients Team in Edinburgh: Your Opportunity to Shine in Financial Planning Administration! Are you ready to be the backbone of a thriving financial advisory service? Our client is seeking a meticulous and proactive Financial Planning Administrator to join their Edinburgh office. Dive into a role where you are the face and voice of their company,...

  • Billing Controller

    4 weeks ago


    Dalkeith, Midlothian, United Kingdom Three Bridges Recruitment LTD Full time €26,000 - €32,000

    Three Bridges Recruitment are working with a professional services company that Is looking for a Revenue Controller working within the Finance Team. Excellent benefits including pension, healthcare, bonus, subsidised gym membership & generous holiday allowance Professional but relaxed culture with a community feel Excellent work-life balance where, for...

  • Billing Controller

    4 weeks ago


    Dalkeith, Midlothian, United Kingdom Three Bridges Recruitment LTD Full time €26,000 - €32,000

    Three Bridges Recruitment are working with a professional services company that Is looking for a Revenue Controller working within the Finance Team. Excellent benefits including pension, healthcare, bonus, subsidised gym membership & generous holiday allowance Professional but relaxed culture with a community feel Excellent work-life balance where, for...