Regulatory Affairs Specialist

4 weeks ago


United Kingdom Corriculo Recruitment Full time

Regulatory Affairs Specialist - Fully Remote

This is an excellent Regulatory Affairs Specialist / RA Specialist, working for a company with a growing reputation in their field. The successful Regulatory Affairs Specialist / RA Specialist will have hands-on knowledge of FDA regulations, ISO standards & SaMD - as well as proven experience working with medical devices that use AI & Machine Learning. The purpose of this role is to provide expert advice and guidance on FDA approvals and 510(k) submissions.

The Company

The Regulatory Affairs Specialist / RA Specialist will join an innovative Machine Learning MedTech start-up based-in Cambridge. The Regulatory Affairs Specialist / RA Specialist will contribute to a supportive team environment, which rewards hard work and innovative thinking. The current work pattern in place is fully remote.

Benefits

Some of the benefits on offer for the Regulatory Affairs Specialist / RA Specialist, include:

  • Fully Remote working - With options to go into the office if you want to
  • 25 days holiday + BH
  • Employee share options

What’s Required?

The Ideal candidate for the role will have some of the following:

  • Proven experience and knowledge of FDA regulations and requirements for approvals
  • Prior experience completing submissions through 510(k) regulatory pathways
  • Strong knowledge of SaMD (Software as a Medical Device), ideally with experience of radiology and AI / Machine Learning
  • Strong understanding for SaMD development processes according to recognised standards (e.g., IEC 62304, IEC 82304) and other international regulatory requirements.
  • Further experience of UKCA and CE marking, as well as working with multi-disciplinary technical teams is advantageous

The list above is important, but not as important as hiring the right person So if you don't meet all of the criteria above, but feel the role is of interest, please apply or get in touch today to discuss further.

So What's Next?

If you are a Regulatory Affairs Specialist / RA Specialist currently, or looking to harness your career in this direction, and would like to know more about this excellent opportunity; apply now for immediate consideration



  • United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...


  • United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...


  • United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...


  • United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...


  • United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...

  • Regulatory Specialist

    1 month ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...

  • Regulatory Specialist

    2 months ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Specialist

    2 months ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Specialist

    2 months ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...

  • Regulatory Specialist

    2 months ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...


  • United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...


  • United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...


  • United Kingdom Corin Group Full time

    Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK Req #233 04 April 2024 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,...


  • United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...


  • United Kingdom Meet Recruitment Limited Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...


  • United Kingdom Corin Group Full time

    Senior Regulatory Affairs Specialist to work at Corin, you will 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...


  • United Kingdom Corin Group Full time

    Senior Regulatory Affairs Specialist to work at Corin, you will 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...


  • United Kingdom Corin Group Full time

    Senior Regulatory Affairs Specialist to work at Corin, you will 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...


  • United Kingdom Meet Recruitment Limited Full time

    Regulatory Affairs Specialist - Medical Device Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to...


  • United Kingdom VRS Regulatory Full time

    Global household name speciality chemical company Responsibility for National and Regional regulatory compliance Diverse business units – complex aqueous mixtures and substances Become a regulatory subject matter expert This will be a highly diverse role; typical duties include answering complex customer regulatory enquiries, researching/impact...