Regulatory Affairs Senior Associate

2 weeks ago

Edinburgh, Edinburgh, United Kingdom SRG Full time

SRG is working with a leading Biotechnology company who are looking for a Senior Regulatory Compliance Officer to join their team on a permanent basis.

The Senior Regulatory Compliance Officer is responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems. This includes overseeing initial compilation of design control evidence, supplier management, incoming inspection and product release processes, product submissions, post-market surveillance, vigilance, and associated reporting.

The Role:
  • Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO 13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
  • Advising staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Ensuring Quality Assurance release of incoming goods, intermediate, and final product obligations.
  • Being a point of contact for regulatory and quality compliance issues.
  • Interfacing with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (Medical Device Reporting).
  • Supporting QMS organization during regulatory inspections or certifications audits.
  • Conducting all duties in compliance with company Quality Management System and cGMP, GCP, and ISO 13485 requirements.
Requirements:
  • Scientific degree.
  • Extensive regulatory experience within Medical Devices / IVD.
  • Experience of working within an FDA licensed manufacturing facility.
  • Specialist knowledge of regulations as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, BLA, CMDR, etc.).
  • Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics.
Benefits:
  • Private Medical cover.
  • Life assurance.
  • Additional annual leave.
  • Cycle to work scheme + more.

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Edinburgh, Edinburgh, United Kingdom Ramboll Group AS Full time

    Job DescriptionWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our Health Sciences department at Ramboll Group A/S. As a key member of our team, you will play a crucial role in supporting our clients in the chemical industry with regulatory affairs and product stewardship.Key Responsibilities:Provide subject matter expertise in...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Edinburgh, Edinburgh, United Kingdom Ramboll Group AS Full time

    Job DescriptionWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our Health Sciences department at Ramboll Group A/S. As a key member of our team, you will play a crucial role in supporting our clients in the chemical industry with regulatory affairs and product stewardship.Key Responsibilities:Provide subject matter expertise in...

  • Regulatory Affairs Specialist

    1 week ago

    Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time £35,000 - £40,000

    Job Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12 month fixed term contractLocation: Outskirts of Edinburgh (Hybrid)About the Role:We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our growing Regulatory Affairs Department at Cpl Life Sciences. As a Senior Regulatory Compliance Officer, you will be...

  • Regulatory Affairs Specialist

    1 week ago

    Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time £35,000 - £40,000

    Job Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12 month fixed term contractLocation: Outskirts of Edinburgh (Hybrid)About the Role:We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our growing Regulatory Affairs Department at Cpl Life Sciences. As a Senior Regulatory Compliance Officer, you will be...

  • Regulatory Affairs Specialist

    5 days ago

    Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12-month fixed term contractLocation: Outskirts of Edinburgh (Hybrid)Remuneration: £35,000 - £40,000We are seeking a highly skilled Senior Regulatory Compliance Officer to join our growing IVD manufacturer and support our Regulatory Affairs Department. In this role, you will be responsible for...

  • Regulatory Affairs Specialist

    5 days ago

    Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12-month fixed term contractLocation: Outskirts of Edinburgh (Hybrid)Remuneration: £35,000 - £40,000We are seeking a highly skilled Senior Regulatory Compliance Officer to join our growing IVD manufacturer and support our Regulatory Affairs Department. In this role, you will be responsible for...

  • Regulatory Affairs Senior Associate

    2 weeks ago

    Edinburgh, Edinburgh, United Kingdom SRG Full time

    SRG is working with a leading Biotechnology company who are looking for a Senior Regulatory Compliance Officer to join their team on a permanent basis.The Senior Regulatory Compliance Officer is responsible for delivering end-to-end regulatory packages under the ODM-Distributor scheme in compliance with an established quality management system. This includes...

  • Regulatory Affairs Specialist

    2 weeks ago

    Edinburgh, Edinburgh, United Kingdom SRG Full time

    About the Role:The Regulatory Affairs Officer will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance, and associated reporting, regulatory and standard watch.Key Responsibilities:Act as the main contact for regulatory compliance...

  • Regulatory Affairs Specialist

    2 weeks ago

    Edinburgh, Edinburgh, United Kingdom SRG Full time

    About the Role:The Regulatory Affairs Officer will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance, and associated reporting, regulatory and standard watch.Key Responsibilities:Act as the main contact for regulatory compliance...

  • Regulatory Affairs Specialist

    3 days ago

    Edinburgh, Edinburgh, United Kingdom SRG Full time

    Regulatory Affairs OfficerSRG is seeking a highly skilled Regulatory Affairs Officer to join their team in Edinburgh. As a key member of the team, you will be responsible for ensuring compliance with regulatory requirements and implementing processes to maintain regulatory standards.The Role:Act as the primary point of contact for regulatory compliance...

  • Regulatory Affairs Specialist

    3 days ago

    Edinburgh, Edinburgh, United Kingdom SRG Full time

    Regulatory Affairs OfficerSRG is seeking a highly skilled Regulatory Affairs Officer to join their team in Edinburgh. As a key member of the team, you will be responsible for ensuring compliance with regulatory requirements and implementing processes to maintain regulatory standards.The Role:Act as the primary point of contact for regulatory compliance...

  • Regulatory Affairs Specialist

    2 weeks ago

    Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12 month fixed term contractLocation: HybridRemuneration: £35,000 - £40,000About the RoleCpl Life Sciences is seeking a highly skilled Senior Regulatory Compliance Officer to join our growing Regulatory Affairs Department. As a key member of our team, you will be responsible for delivering...

  • Regulatory Affairs Specialist

    2 weeks ago

    Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12 month fixed term contractLocation: HybridRemuneration: £35,000 - £40,000About the RoleCpl Life Sciences is seeking a highly skilled Senior Regulatory Compliance Officer to join our growing Regulatory Affairs Department. As a key member of our team, you will be responsible for delivering...

  • Regulatory Affairs Specialist

    1 hour ago

    Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

    Job Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12 month fixed term contractLocation: Outskirts of Edinburgh (Hybrid)We are seeking an experienced Senior Regulatory Compliance Officer to join our growing IVD manufacturer and support our Regulatory Affairs Department. In this role, you will be responsible for delivering end-to-end regulatory...

  • Public Affairs Specialist

    1 week ago

    Edinburgh, Edinburgh, United Kingdom Financial Conduct Authority Full time

    About the RoleWe are seeking a highly skilled Public Affairs Associate to join our team at the Financial Conduct Authority (FCA). As a key member of our Communications division, you will play a critical role in building and maintaining relationships with Parliament and other stakeholders to ensure public confidence in our work.Key ResponsibilitiesDevelop and...

  • Public Affairs Specialist

    1 week ago

    Edinburgh, Edinburgh, United Kingdom Financial Conduct Authority Full time

    About the RoleWe are seeking a highly skilled Public Affairs Associate to join our team at the Financial Conduct Authority (FCA). As a key member of our Communications division, you will play a critical role in building and maintaining relationships with Parliament and other stakeholders to ensure public confidence in our work.Key ResponsibilitiesDevelop and...

  • Regulatory Compliance Specialist

    3 days ago

    Edinburgh, Edinburgh, United Kingdom Entrust Resource Solutions Full time

    Job DescriptionRegulatory Compliance AssociateIVDGlobal OpportunitiesWe are excited to offer a challenging role with a leading company in the diagnostics industry. With a strong presence in the UK, EU, APAC, and US markets, this is an excellent opportunity to take your regulatory experience to the next level and work on a global scale.This is a stable...

  • Regulatory Compliance Specialist

    3 days ago

    Edinburgh, Edinburgh, United Kingdom Entrust Resource Solutions Full time

    Job DescriptionRegulatory Compliance AssociateIVDGlobal OpportunitiesWe are excited to offer a challenging role with a leading company in the diagnostics industry. With a strong presence in the UK, EU, APAC, and US markets, this is an excellent opportunity to take your regulatory experience to the next level and work on a global scale.This is a stable...

  • Senior Regulatory Compliance Officer

    4 hours ago

    Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job DescriptionJob Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12 month fixed term contractLocation: Outskirts of Edinburgh (Hybrid)Remuneration: £35,000 - £40,000We are seeking an experienced Senior Regulatory Compliance Officer to join our growing Regulatory Affairs Department. In this role, you will be responsible for delivering...

  • Senior Regulatory Compliance Officer

    2 hours ago

    Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job DescriptionJob Title: Senior Regulatory Compliance Officer - IVDsJob Type: 12 month fixed term contractLocation: Outskirts of Edinburgh (Hybrid)Remuneration: £35,000 - £40,000We are seeking an experienced Senior Regulatory Compliance Officer to join our growing Regulatory Affairs Department. In this role, you will be responsible for delivering...