Senior Regulatory Affairs Specialist

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Cirencester, United Kingdom Corin Group Full time

Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to make regulatory submissions and filings.

You will be part of the Global Regulatory Affairs team based in our Cirencester Head Office on a permanent hybrid contract, a minimum of 2 days a week onsite


The key responsibilities of the Senior Regulatory Affairs Specialist are to;

  • Liaise with Corin Ltd R&D and Product Management to provide regulatory input into NPI Project Core teams
  • Timely preparation and submission of regulatory applications (EG 510(k), CE Marking, Design Dossier, IDE, Supplements, Annual Reports, PMA and PMA supplements)
  • Interface with regulatory reviewers through written and oral communications as needed and assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS.
  • Liaise with other Corin Ltd departments serving as a Regulatory representative on cross-functional teams including, but not limited to, Corin Quality, Product Development, Product Engineering, Operations & Manufacturing, Product Management, Clinical Research, IT, and Corin Group subsidiaries.
  • Undertake deputized duties as required.

The ideal Senior Regulatory Affairs Specialist will have;

  • A degree or equivalent in a Life Science subject (Biochemistry, Biotechnology, Microbiology, Bioinformatics) and/or a significant area of expertise developed through experience and a positive track record.
  • Experience in medical device/orthopaedics regulatory affairs, ideally Class 3 is essential
  • Experience in clinical evaluation report writing for class 3 medical devices is essential
  • Detailed knowledge of the worldwide regulations and guidance for medical devices.
  • Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements.
  • Understanding of Quality Management Systems - FDA QSR, ISO 13485.
  • Detail-oriented and excellent written and verbal communication skills.


  • Senior Regulatory Affairs Specialist

    Found in: Talent UK 2A C2 - 2 weeks ago


    Cirencester, United Kingdom Corin Group Full time

    Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to make...

  • Senior Regulatory Affairs Specialist

    Found in: Whatjobs ES C2 - 7 days ago


    Cirencester, United Kingdom Corin Group Full time

    Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to make...


  • Cirencester, Gloucestershire, United Kingdom Corin Group Full time

    Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to...

  • Senior Regulatory Affairs Specialist

    Found in: Jooble UK C2 - 2 weeks ago


    Cirencester, Gloucestershire, United Kingdom Corin Group Full time

    Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to...


  • Cirencester, United Kingdom Artis Recruitment Full time

    Are you a financial services professional with strong analytical skills and an understanding of compliance? Fancy working in a niche team that focusses around compliance for SMCR (Senior Managers and Certification Regime)? If so we want to hear from youas our client is looking for someone like you to join the team for the next 12 months. This critical role...


  • Cirencester, United Kingdom St. James's Place Full time

    Who we are People have always been at the heart of St. James’s Place, we value long-term relationships and we are a home for people who care about the future - financially, environmentally and socially. These core values have enabled us to become a leading FTSE 100 Wealth Management company. **Location**: Cirencester Office **Employment Type**:...

  • Accounts Technician

    4 days ago


    Cirencester, United Kingdom Trial Balance Consulting Full time

    Do you like the sound of a varied and interesting role working for one of the friendliest teams in the region? Are you looking for a role offering plenty of autonomy and client contact? This could be just the position for you My client is very well established and has a very stable and supportive team of professionals looking after a loyal client portfolio....


  • Cirencester, United Kingdom Talent Hire Group Full time

    This person will support the marketing requirements and be involved with the briefing of design and web agencies as well as developing a range of ideas and initiatives. They will deal with multiple cases in a timely and efficient manner ensuring all parties are appropriately updated and accurate records are maintained via the case management system. **What...


  • Cirencester, Gloucestershire, United Kingdom Alpine Fox Ltd Full time

    Senior Contracts Manager Listed Building Renovations Location: The Cotswolds Salary: GBP60,000 - GBP75,000 per annum, depending on experience Join a prestigious building contractor in a critical leadership role that blends traditional craftsmanship with modern construction management. We are seeking a Senior Contracts Manager to oversee...


  • Cirencester, United Kingdom Royal Agricultural University Full time

    Royal ~ Agricult~ral Rl\ University **Student Recruitment Officer (Outreach)** Job Description*** The Role **Job title**:Student Recruitment Officer (Outreach)*** **Department**:External Relations*** **Responsible to**:Head of Student Recruitment **Location**:Royal Agricultural University, Cirencester*** **Salary**:Grade 6: £28,759 -£33,965 per...

  • Senior ICT Infrastructure Specialist

    Found in: Jooble UK C2 - 5 days ago


    Cirencester, Gloucestershire, United Kingdom Hunter Selection Full time

    Infrastructure Engineer - £45k - £50k - Hybrid (Cirencester) You will be working with a growing IT team, supporting the Head of IT with projects as well as being the key escalation point for junior members of the team. You will be responsible for third line support, and working across their Networks, Servers, and Desktop Infrastructure. Ensuring the...

  • Account Manager

    6 days ago


    Cirencester, Gloucestershire, United Kingdom Henry Nicholas Associates Ltd Full time

    Job Description If you're just starting out in your marketing career we have a opportunity that could be right for you. If you've got a passion for data and CRM and want to help clients get the most out of their campaigns, consider applying for this one. We've got an opportunity for an Account Manager or Senior Account Manager for a CRM specialist in the...

  • Account Manager

    6 days ago


    Cirencester, Gloucestershire, United Kingdom Henry Nicholas Associates Ltd Full time

    Job Description If you're just starting out in your marketing career we have a opportunity that could be right for you. If you've got a passion for data and CRM and want to help clients get the most out of their campaigns, consider applying for this one. We've got an opportunity for an Account Manager or Senior Account Manager for a CRM...


  • Cirencester, Gloucestershire, United Kingdom Austin Rose Associates Limited Full time

    Are you seeking a challenging career within a specialist recruitment market? A Trainee Headhunter is sought for this specialist accountancy and finance recruitment consultancy as part of an exciting phase of expansion. Dealing with mid to senior level accountancy and finance professionals, we pride ourselves on being able to find the 'best in the market'...

  • Project Manager

    Found in: Talent UK C2 - 2 weeks ago


    Cirencester, United Kingdom Octavius Infrastructure Full time

    We are recruiting for 2 x Project Managers (PM) for Enhancements on stations and buildings across the Wales & Western region for CP7. As PM your expertise and leadership will be instrumental in ensuring these projects are completed on time, within budget, and to the highest quality standards. Octavius Infrastructure are a leading civil engineering...


  • Cirencester, Gloucestershire, United Kingdom Flat Fee Recruiter Full time

    Procurement Lead - Cirencester, United Kingdom - Flat Fee Recruiter Our client, a leading provider of infrastructure and managed services, is currently seeking an experienced Procurement Lead to join their team in Cirencester. Procurement Lead – Business Operations Based at the Cirencester head office ~ Full time, permanent ~£Full UK driving...

  • Account Manager

    3 weeks ago


    Cirencester, Gloucestershire, United Kingdom Henry Nicholas Associates Ltd Full time

    If you're just starting out in your marketing career we have a opportunity that could be right for you. If you've got a passion for data and CRM and want to help clients get the most out of their campaigns, consider applying for this one. We've got an opportunity for an Account Manager or Senior Account Manager for a CRM specialist in the Gloucestershire...

  • Account Manager

    Found in: Jooble UK C2 - 3 weeks ago


    Cirencester, Gloucestershire, United Kingdom Henry Nicholas Associates Ltd Full time

    If you're just starting out in your marketing career we have a opportunity that could be right for you. If you've got a passion for data and CRM and want to help clients get the most out of their campaigns, consider applying for this one. We've got an opportunity for an Account Manager or Senior Account Manager for a CRM specialist in the Gloucestershire...


  • Cirencester, Gloucestershire, United Kingdom Austin Rose Associates Limited Full time

    Are you seeking a challenging career within a specialist recruitment market? Do you possess the drive and confidence to work in a sales environment where you will be expected to work autonomously in generating new candidates through research and structured telesales? A Trainee Headhunter is sought for this specialist accountancy and finance recruitment...

  • Procurement Lead

    11 hours ago


    Cirencester, Gloucestershire, United Kingdom Flat Fee Recruiter Full time

    No more applications are being accepted for this job Procurement Lead - Cirencester, United Kingdom - Flat Fee Recruiter Description Do you have experience managing a team? Our client, a leading provider of infrastructure and managed services, is currently seeking an experienced Procurement Lead to join their team in Cirencester. Procurement Lead –...