1 x RA Officer 1 x Senior RA Officer

1 month ago

Edinburgh, United Kingdom SRG Full time

Job Description

Here at SRG, we are proud to be supporting this established IVD company on their search for two regulatory affairs professionals.

Regulatory Affairs Officer

The role is 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.

It is also responsible to build, implement and maintain regulatory compliance processes including, regulatory evaluation of changes and non-conformances, post-market surveillance, vigilance and associated reporting, regulatory and standard watch. Furthermore, the role is responsible for providing guidance to the company on regulatory requirements and aspects.

· Prepare and compile regulatory documentation, coordinate, and execute regulatory submission with:

  • FDA
  • European Notified Bodies
  • Health Canada
  • Any other territories as appropriate

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.

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

· Ensure maintenance of product regulatory documents and technical files to ensure ongoing compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 CFRs, BLA, 510(k), CMDR – Part 1 requirements and other non-registered product requirements to support compliance.

· Advise the company’s staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.

  • Develop product labelling regulatory requirements for the company’s products and for customer contracted products including but not limited to package labels, product labels and instructions for use.

· Ensure post-market surveillance obligations are met and maintain the post-market surveillance process.

· Lead and coordinate the vigilance process in interface with the complaint handling process.

· Ensure Vigilance reporting obligations, i.e. interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (Biological Products Deviation Reports).

· Evaluate Product/Processes Non-Conformances, determine whether they need to be reported to the Competent Authorities

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

Senior Regulatory Affairs Officer

The role is responsible for building regulatory strategy, determine applicable regulatory requirements, propose solutions to comply with regulatory requirements and manage product license registration with the appropriate regulatory authorities worldwide. Furthermore, the role is responsible for providing guidance to the company on regulatory requirements and aspects.

The role will provide support to the Head of Pre-Market 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.

· Prepare and compile regulatory documentation, coordinate and execute regulatory submission with:

  • FDA
  • European Notified Bodies
  • Health Canada
  • Any other territories as appropriate

in compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate.

· Review analytical data from development studies and performance evaluation studies to ensure regulatory requirements are met.

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

· Develop product labelling regulatory requirements for Quotient 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 development of product labelling.

· Contribute to the regulatory watch process by maintaining knowledge of new or update 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) – Part 1 and other non-registered product requirements to support compliance for Quotient and its products.

· 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 on a regular basis 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 Company’s 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, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.

As the ideal candidate for these roles, you will have relevant experience working with regulatory affairs for the IVD/Medical Device market. Knowledge and practical experience of CE (IVDR) and FDA regulations, including the preparation of PMA, BLA and/or 510k submissions is desirable.

#J-18808-Ljbffr

  • 2 X Consultant in Emergency Medicine and 1 X Locum

    1 month ago

    Edinburgh, United Kingdom NHS Scotland Full time

    **NHS Lothian** **2 x Consultant in Emergency Medicine** 40 hours at Royal Infirmary of Edinburgh and 32 hours at St John’s Hospital **1 x Locum Consultant in Emergency Medicine** Royal Infirmary of Edinburgh **Reference: CG2718 CG2722 CG2717** NHS Lothian is committed to encouraging equality and diversity among our workforce and eliminating unlawful...

  • Electricians Mate

    1 month ago

    Edinburgh, United Kingdom Meridian Business Support Full time

    RA-606-1 **Posted: 16/04/2024** **£18** **Edinburgh, Scotland,** **Contract** - Meridian Business Support are currently looking for Electrician's Mates. We are currently looking for Electrician's Mates to start on a 6 weeks project. The ideal Electrician's Mates will require a valid ECS card & Previous Electrical Experience. - The main duties will...

  • 4 x Activity Co-Ordinator, Various Locations, 480.45

    4 days ago

    Edinburgh, United Kingdom West Lothian Council Full time

    Advert 1 x 36 hours, 52.14 weeks per year, Permanent - Limecroft Care Home 1 x 36 hours, 52.14 weeks per year, Permanent - Burngrange Care Home 1 x 16 hours, 52.14 weeks per year, Permanent - Whitdale Care Home 1 x 20 hours, 52.14 weeks per year, Permanent - Whitdale Care Home We are keen to employ a diverse workforce that reflects the...

  • Territory Sales Representative X 2

    1 month ago

    Edinburgh, United Kingdom Cavendish Maine Recruitment Full time

    **Territory Sales Representative x 2** **Branded housewares/homewares** **£22,000 Basic - rising to £24,000 after 6 months + bonus + car + lunch allowance + pension, laptop & mobile phone.** **Location: 1 x South East & 1 x Scotland** **Reference: SV/7865** **Are you keen to embark on a sales career within the premium consumer products...

  • 181906 R1 Fire/incident Response Officer

    1 month ago

    Edinburgh, United Kingdom NHS Scotland Full time

    Please note: As this post can be part-time the salary would be pro-rata. The purpose of this post: - Provide a 24/7 Incident Response / Fire Watch service, that enables the effective and efficient delivery of clinical and non-clinical services to the Royal Infirmary Edinburgh. - Assist with evacuation of patients in event of an incident, detect and address...

  • Cleaner X 4

    1 month ago

    Edinburgh, United Kingdom Blue Arrow Full time

    Our client is currently recruiting for 4 cleaners required to work at a school on an ongoing basis in Edinburgh EH14 **Job role**: Cleaner x 4 **Pay**: £10.90 p/h (PAYE) **Start date**: ASAP **Duration**: Monday - Friday, ongoing **Hours**: 16:00hrs to 20:00hrs Monday to Thursday and Friday 13:00hrs to 17:00hrs **Location**: Edinburgh EH14 You MUST...

  • Senior Solution Architect

    2 weeks ago

    Edinburgh, United Kingdom Version 1 Full time

    Job Description Version 1 are a AWS Premier Consulting Partner, which is the highest tier of AWS Partnership available. You will be working for the AWS Practice which consists of some of the best Architects, DevOps Engineers and Consultants. The customer engagements are varied and the exposure to cutting-edge technologies is always present.  You...

  • Oracle Payroll Cloud Specialist

    4 days ago

    Edinburgh, United Kingdom Version 1 Full time

    Job Description Version 1’s market leading Enterprise Applications Practice specialises in Finance, Supply Chain, HR, and Payroll Solutions with over 650 Oracle Specialists across the UK, Ireland, US, Australia, India and Slovenia. We deliver consulting and managed services to transform and optimise ways of working for more than 230 customers through...

  • School Cleaner X 3

    1 month ago

    Edinburgh, United Kingdom Blue Arrow Ltd Full time

    Our client is currently recruiting for 3 cleaners to work at a school on an ongoing basis in Edinburgh. **Job role**: Cleaner x 3 **Pay**: £10.90 p/h (PAYE) **Start date**: ASAP **Duration**: Monday - Friday, ongoing **Hours**: 15:30hrs to 18:30hrs Monday to Thursday and Friday 13:00hrs to 16:00hrs **Location**: Edinburgh EH7 You MUST have a valid PVG...

  • 2 X Structural Engineer

    2 weeks ago

    Edinburgh, United Kingdom First Recruitment Group Full time

    2 x Structural Engineers Initial 12 Month Contract Kingston-upon-Thames, Surrey - 3 days per week in the office, 2 days per week working from home Outside IR35 Oil & Gas/Offshore Wind sector 2 Senior/ Lead Structural Engineers are required to work for a large offshore installation contractor based in Kingston-upon-Thames, Surrey on a long term contract...

  • Senior Databricks Engineer

    4 weeks ago

    Edinburgh, United Kingdom Version 1 Full time

    Job Description This is an exciting opportunity for an experienced developer of large-scale data solutions. You will join a team delivering a transformative cloud hosted data platform for a key Version 1 customer. The ideal candidate will have a proven track record as a senior/self-starting data engineer in implementing data ingestion and...

  • Maternity Cover Gp Receptionist

    1 month ago

    Edinburgh, United Kingdom Ladywell Medical Centre East Full time

    SALARY: minimum starting salary of £20,685 (depending on experience) HOURS: Full Time - 37 hours per week (08:00-16:30 Monday, Wednesday, Thursday and Friday. 08:00-16:00 on Tuesday) POSITION TYPE: Temporary Maternity Cover GP Receptionist POSITION DURATION: 10 months (05/06/2023- 28/03/2024) Come and work with us in a rewarding and secure job! An...

  • 1 / 1 Bricklaying Gang

    1 month ago

    Edinburgh, United Kingdom Linsco Recruitment Full time

    Linsco Recruitment requires a 1/1 bricklaying gang in Edinburgh for an immediate start. Hourly rate is negotiable for both the bricklayers and the labourer. Requirements for the position are: - A valid CSCS card - Previous experience on site - Own tools - References upon request from previous employers If interested in the position please contact Jack on...

  • Cleaner

    1 month ago

    Edinburgh, United Kingdom United Cleaning Solutions Full time

    We are looking to recruit for various cleaning roles in Edinburgh Office cleaner Monday to Friday 6-8.30am on George street £11ph Bar cleaning x 2 people 5-6.30am Monday to Friday 7.5hrs pw Frederick street Bar cleaning x 2 people Bruntsfield Monday to Friday 6.30-8am Bar cleaning x 2 people, Stockbridge,5am to 7am Monday,Wednesday, Friday Various...

  • Copy of Head of Private Sector for Digital, Data

    19 hours ago

    Edinburgh, United Kingdom Version 1 Full time

    Company Description Version 1 is delighted to announce the opening of an exciting new role in our Digital, Data and Cloud leadership team for a Sector Head for our Private Sector business within our delivery organisation, with specific focus on Pharmaceuticals and Life Sciences, Manufacturing and Telecoms. Having experienced significant growth, our...

  • Senior Azure Platform Consultant

    4 weeks ago

    Edinburgh, United Kingdom Version 1 Full time

    Job Description You will: Work with customers and Version 1 colleagues delivering high quality solutions on Microsoft Azure Engage with customers to understand requirements and identify solutions and opportunities. Use DevOps processes and tooling for the delivery of IaaS and PaaS services using Infrastructure as Code (IaC) Produce and contribute...

  • Data Engineer

    2 days ago

    Edinburgh, United Kingdom Version 1 Full time

    Job DescriptionAs a Data Engineer you will join a team delivering transformative cloud hosted data platforms for a Version 1 customers.You will have a proven track record as a Data Engineer and be adept in your ability to implement data ingestion and transformation pipelines for large scale organisations.This career may align to individuals who like to work...

  • Bricklayer 1 & 1

    7 days ago

    Edinburgh, United Kingdom Apex Full time

    We Require a 1 & 1 Bricklayer and labourer squad for a commercial site in Edinburgh EH9 postcode area, Job duties will be Various works, Block work etc, Labourer will assist with Bricklaying duties. 1 weeks duration, could go longer, Job starts 15/05/2024, Must be time served and hold valid CSCS card. Please contact Danielle on 07392866667 if interested...

  • Business Controls Partner, Digital X

    4 weeks ago

    Edinburgh, United Kingdom NatWest Full time

    Join us as a Business Controls Partner, Digital X - If you have a risk management or regulatory background and are looking for a new challenge, this could be the ideal role for you - You’ll partner with the business and Risk function to identify, assess and manage the risks within the agreed risk appetite, using our risk framework to inspire a team of...

  • Box Office Supervisor X 4

    4 weeks ago

    Edinburgh, United Kingdom Edinburgh Festival Fringe Society Full time

    **Closing date**: 10:00 on Monday 8 April 2024 **Interview date**: Tuesday 23 - Thursday 25 April 2024 **Start date**: Monday 10 June 2024 **End date**: Monday 26 August 2024 **Location**: Office based, central Edinburgh **Background**: The idea at the heart of the Edinburgh Festival Fringe is simple: anyone with a desire to perform and a venue willing to...