Senior Regulatory Compliance Officer
4 weeks ago
SRG is working with a leading Biotechnology company based in the Edinburgh area who are looking for a Regulatory Compliance Officer to join their team on a 12 month basis.
Ideally this will be a hybrid role but remote working will be considered for the right candidate.
The Regulatory Officer is responsible to deliver end to end regulatory package under ODM-Distributor scheme in compliance with an established quality management system, overseeing initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance and associated reporting
The Role:
Preparing and compiling regulatory documentation, coordinating and executing regulatory submission in compliance with ISO13485, 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.
Ensure Quality Assurance release of incoming goods, intermediate and final product obligations.
Ensure Supplier management obligations
Ensure Post-market surveillance obligations
Ensure Vigilance reporting obligations for
Be a point of contact for regulatory & quality compliance issues.
Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
Evaluate Product/Processes Non-Conformances, determine whether their need to be reported to the Competent Authorities.
Support QMS organisation during regulatory inspections or certifications audits.
Perform any other duties as reasonably requested from the Company from time to time.
Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 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.)
Experience in post market surveillance.
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.Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy
-
Senior Regulatory Compliance Officer
3 weeks ago
Edinburgh, Edinburgh, United Kingdom ACCA Full timeRole OverviewWe are seeking a Senior Regulatory Compliance Officer to support our Authorisation team in ensuring ACCA's statutory recognition for audit is maintained.This role plays a vital part in ensuring compliance with ACCA's lead regulators to uphold standards.Administer ACCA's regulatory arrangements for the issue of the Practising Certificate and...
-
Regulatory Compliance Officer
4 days ago
Edinburgh, Edinburgh, United Kingdom Cloud Online Recruitment Full timeJob Title: Regulatory Compliance OfficerLocation: Flexible (Remote)Salary: £35,000 - £45,000 per annumJob Type: PermanentWe are seeking a highly organized and detail-oriented Regulatory Compliance Officer to join our team at Cloud Online Recruitment. As a key member of our Secretariat, you will be responsible for administering the Faculty's regulatory...
-
Regulatory Compliance Specialist
3 days ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeSRG, a leading Biotechnology company based in Edinburgh, is seeking a Senior Regulatory Compliance Officer to join their team on a permanent basis. The estimated salary for this role is £55,000-£65,000 per annum.About the RoleThe Senior Regulatory Officer will be responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in...
-
Regulatory Compliance Officer
2 weeks ago
Edinburgh, Edinburgh, United Kingdom Faculty of Advocates Full time**Key Responsibilities**Support the Co-CEO and Chair of the Regulatory Compliance Committee in administering the Faculty's regulatory responsibilities.Administer and coordinate processes and procedures, including Faculty responses to Law Reform Consultations, Complaints, and Disciplinary Rule Process.Oversee policies related to Data Protection, Immigration,...
-
Regulatory Compliance Officer
2 days ago
Edinburgh, Edinburgh, United Kingdom Argyll & Bute Council Full timeJob SummaryWe are seeking a Regulatory Compliance Officer to join our Trading Standards team in Argyll & Bute. As a key member of the team, you will be responsible for providing advice to local businesses on compliance with regulations related to product safety, animal feedstuffs, weights and measures, and fair trading.About the RoleThe successful candidate...
-
Regulatory Compliance Specialist
1 month ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeSRG is seeking a Senior Regulatory Compliance Officer to join their team in Edinburgh. The successful candidate will be responsible for delivering end-to-end regulatory packages under the ODM-Distributor scheme, ensuring compliance with ISO13485, IVD 2017/746 Regulation, and FDA 21 Code of Federal Regulations (CFRs).The Role:Preparing and compiling...
-
Regulatory Compliance Officer
6 months ago
Edinburgh, United Kingdom HSE Full timeWe have an exciting opportunity for a Regulatory Compliance Officer (RCO) to join our Chemicals, Explosives and Microbiological Hazards Divisions. The RCO role is a front facing role which forms a key part of the operational team. RCOs are required to work alone and alongside inspectors and specialists supporting their work. The work of the RCO is...
-
Senior Regulatory Compliance Manager
4 weeks ago
Edinburgh, Edinburgh, United Kingdom ENGINEERINGUK Full timeSenior Regulatory Compliance ManagerAbout this roleJob Summary:ENGINEERINGUK is seeking a highly skilled Senior Regulatory Compliance Manager to join our EMEA Regulatory Engagement and Development team. The successful candidate will be responsible for managing high-risk or complex regulatory interactions across EMEA, including the preparation of materials...
-
Regulatory Compliance Officer
1 day ago
Edinburgh, Edinburgh, United Kingdom NURSING & MIDWIFERY COUNCIL Full timeAbout the JobWe are looking for a Regulatory Compliance Officer to join our Investigations team. As a key member of the team, you will be responsible for planning, managing, and prioritizing investigation caseload to meet department objectives.You will work closely with witnesses, conduct interviews, and draft statements to a high standard. The ideal...
-
Regulatory Compliance Specialist
4 weeks ago
Edinburgh, Edinburgh, United Kingdom HSE Full timeWe are seeking a highly skilled Regulatory Compliance Officer to join our team at HSE. The successful candidate will play a key role in ensuring compliance with regulatory requirements and enforcing health and safety standards in the workplace.The Regulatory Compliance Officer will be responsible for gathering intelligence about workplaces, liaising with...
-
Senior Regulatory Associate
6 months ago
Edinburgh, United Kingdom Clinical Professionals Full time**Reference Number: JO-2403-531737** 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 exciting opportunity to join an established and growing IVD manufacturer and...
-
Regulatory Compliance Specialist
2 weeks ago
Edinburgh, Edinburgh, United Kingdom HSE Full timeJob Role: Regulatory Compliance OfficerKey Responsibilities:Gather intelligence about workplaces to inform regulatory decisions.Liaise with SEPA and local authorities.Make enquiries into reported incidents or concerns.Take voluntary witness statements.Secure and process evidence.Visiting workplaces to provide advice and identify matters of concern.Attend...
-
Regulatory Compliance Specialist
1 month ago
Edinburgh, Edinburgh, United Kingdom Blackrock, Inc. Full timeAbout this roleRegulatory Solutions is a growing team responsible for designing, implementing and leading all aspects of BlackRock's regulatory processes. The Regulatory Operations team plays a key role; we own many of BlackRock's most sophisticated and critical regulatory reporting processes. We also act as the translation layer between Legal & Compliance,...
-
Regulatory Compliance Specialist
1 month ago
Edinburgh, Edinburgh, United Kingdom ENGINEERINGUK Full timeAbout this roleTeam OverviewOur Regulatory Solutions team is responsible for designing, implementing, and leading all aspects of BlackRock's regulatory processes. We own many of BlackRock's most sophisticated and critical regulatory reporting processes, acting as the translation layer between Legal & Compliance, Technology, and Operations teams. This role...
-
Regulatory Compliance Associate
1 month ago
Edinburgh, Edinburgh, United Kingdom ENGINEERINGUK Full timeCompliance Monitoring & Testing, AssociateAbout this roleBlackRock's Legal & Compliance (L&C) Department protects BlackRock's reputation and provides advice and oversight of BlackRock's business. The department is focused on:Actively participating in business decisions to champion our clients' interests and assist the business in translating compliance...
-
Regulatory Compliance Expert
4 weeks ago
Edinburgh, Edinburgh, United Kingdom Unreal Gigs Full timeRegTech SpecialistUnreal Gigs is seeking a highly skilled RegTech Specialist to join our team. As a key member of our compliance team, you will be responsible for developing and implementing regulatory technology solutions that simplify compliance processes and ensure risk mitigation.Key Responsibilities:Design and Implement RegTech Solutions:Develop and...
-
Chief Compliance Officer
5 days ago
Edinburgh, Edinburgh, United Kingdom Tesco Bank Full timeUnlock Your Career Potential">We are seeking a highly skilled Senior Compliance Manager to join our Risk Compliance team at Tesco Bank. As a key member of the 2nd line Risk Function, you will support the Head of Compliance in delivering the Bank's compliance oversight.About the RoleProvide subject matter expertise on consumer regulatory regimes applicable to...
-
Regulatory Compliance Specialist
1 month ago
Edinburgh, Edinburgh, United Kingdom Entrust Resource Solutions Full timeAre you looking for a challenging role in regulatory compliance? We have an exciting opportunity for a Regulatory Compliance Specialist to join our team at Entrust Resource Solutions.Key Responsibilities:Ensure compliance with regulatory requirements in the UK, EU, APAC, and US markets.Work closely with the production and quality teams to implement...
-
Regulatory Compliance Specialist
3 days ago
Edinburgh, Edinburgh, United Kingdom Unreal Gigs Full timeAbout the RoleAt Unreal Gigs, we're looking for a skilled Regulatory Compliance Specialist to join our team. As a key member of our compliance team, you'll be responsible for ensuring our business practices align with regulatory frameworks and industry standards.Key ResponsibilitiesRegulatory Compliance MonitoringMonitor and assess regulatory frameworks...
-
Regulatory Compliance Technologist
2 weeks ago
Edinburgh, Edinburgh, United Kingdom Unreal Gigs Full timeUnreal Gigs' RegTech Specialist OpportunityInnovative companies like ours need forward-thinking individuals to lead the development of cutting-edge regulatory technology (RegTech) solutions. At Unreal Gigs, we're seeking a skilled RegTech Specialist to join our team and play a pivotal role in shaping our compliance framework.Key Responsibilities:Design and...