Senior Regulatory Affairs Specialist

1 week ago


Birmingham, 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 make regulatory submissions and filings.


You will be part of the Global Regulatory Affairs team - We will consider UK residents with permanent working rights in the UK on a remote UK contract as well as hybrid (based 2-3 days a week in Cirencester, Gloucestershire). We can not support a VISA for this role.


The ideal Senior Regulatory Affairs Specialist will have;

  • Extensive experience in medical device/orthopedics regulatory affairs, ideally Class 3 is essential
  • 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 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.



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.


  • Regulatory Affairs

    3 weeks ago


    Birmingham, United Kingdom Siemens Healthineers Full time

    **Now’s our time to inspire the future of healthcare together.** Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in...


  • Birmingham, United Kingdom Taylorollinson Full time

    Regulatory Affairs Manager Location - West Midlands Our client is an established contract manufacturing organisation (CMO) providing services on a global scale. As a fully regulatory compliance facility, our client are able to provide technical innovation supporting with the formulation and development of novel cleaning products across many sectors. An...


  • Birmingham, United Kingdom Taylorollinson Full time

    Regulatory Affairs Manager Location - West Midlands Our client is an established contract manufacturing organisation (CMO) providing services on a global scale. As a fully regulatory compliance facility, our client are able to provide technical innovation supporting with the formulation and development of novel cleaning products across many sectors. An...


  • Birmingham, United Kingdom Taylorollinson Full time

    Regulatory Affairs Manager Our client is an established contract manufacturing organisation (CMO) providing services on a global scale. As a fully regulatory compliance facility, our client are able to provide technical innovation supporting with the formulation and development of novel cleaning products across many sectors. An opportunity has now become...


  • Birmingham, United Kingdom Taylorollinson Full time

    Regulatory Affairs Manager Our client is an established contract manufacturing organisation (CMO) providing services on a global scale. As a fully regulatory compliance facility, our client are able to provide technical innovation supporting with the formulation and development of novel cleaning products across many sectors. An opportunity has now become...


  • Birmingham, Birmingham, United Kingdom Gated Talent Full time

    Head of Regulatory Affairs Are you looking for a role to lead global regulatory filing strategy? Do you have recent experience of regulatory strategy for novel oncology modalities?Have you worked on programs from preclinical stage to filing and launch? Fraser Dove International is partnering exclusively with an innovative biotechnology organisation...


  • Birmingham, Birmingham, United Kingdom Gated Talent Full time

    Head of Regulatory Affairs Are you looking for a role to lead global regulatory filing strategy? Do you have recent experience of regulatory strategy for novel oncology modalities?Have you worked on programs from preclinical stage to filing and launch? Fraser Dove International is partnering exclusively with an innovative biotechnology organisation...


  • Birmingham, United Kingdom Thermo Fisher Scientific Full time

    **At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...

  • Chemistry Graduate

    2 months ago


    Birmingham, United Kingdom VRS Regulatory Full time

    Do you like Chemistry and IT? - Have you recently graduated and are looking for a non-lab role? - Do you enjoy using your communications skills? - Do you enjoy travelling with work? - Would you like to work for a world leading chemical software company? If so, this could be the role for you. **The company**: An exciting opportunity to work for a market...


  • Birmingham, United Kingdom Cpl Life Sciences Full time

    Job Title: Regulatory Affairs ManagerJob Type: 12-Month Contract (inside IR35)Location: Uxbridge or Cambridge – 1 day on-site per monthRate: £45 to £55 per hour (PAYE)This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing...


  • Birmingham, United Kingdom Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...

  • Senior Consultant

    1 month ago


    Birmingham, United Kingdom Ramboll Full time

    This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. Company Description We invite you to bring your experience of product safety and stewardship into play as you support organisations around the world bring to the market products in a range of uses that meet relevant regulatory requirements and are safe...


  • Birmingham, United Kingdom Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...


  • Birmingham, United Kingdom Deutsche Bank Full time

    **Job Title **Auditor - Legal & Regulatory Affairs **Location **Birmingham **Corporate Title **Assistant Vice President You will be part of the Group Audit Chief Administration Office (CAO) Legal & Regulatory Affairs team, reporting into the responsible Principal Audit Manager (PAM) based in Birmingham, reporting to the Chief Audit (CA) with global...

  • Regulatory Caseworker

    3 weeks ago


    Birmingham, United Kingdom RSR Regulatory Full time

    RSR is a public safety & enterprise security recruitment specialist. We assist public safety employers find the right talent. We assist all employers when they want to source public safety and enterprise security skills and experience. RSR are currently working on behalf of our client based in Birmingham for a Regulatory Caseworker. This is a full time,...


  • Birmingham, Birmingham, United Kingdom RSR Regulatory Full time

    RSR is a public safety & enterprise security recruitment specialist. We assist public safety employers find the right talent. We assist all employers when they want to source public safety and enterprise security skills and experience.RSR are currently working on behalf of our client based in Birmingham for a Regulatory Caseworker.This is a full time, fixed...


  • Birmingham, United Kingdom Walker Cole International Full time

    Director of Regulatory AffairsWalker Cole International are delighted to be partnering with a large IVD multinational, who are looking to hire a Director of Regulatory Affairs. This is a fully remote position that requires up to 20% travel. The successful candidate will lead a dynamic team, oversee all regulatory activities, and be responsible for the...


  • Birmingham, United Kingdom STEM Talent Full time

    **Junior Regulatory Assistant** **South Birmingham** **Competitive Salary** Our client is a leading manufacturer of sustainable polymer-based materials, who are committed to reducing environmental impact, and are looking to hire a Junior Regulatory Assistant to help achieve their goals. Our client is fully dedicated to reducing environmental impact and...

  • Senior Ra Specialist

    3 weeks ago


    Birmingham, United Kingdom Nonacus Limited Full time

    **Senior RA Specialist** **Perm** **Birmingham** Nonacus Ltd, is a privately held company developing innovative molecular diagnostics products, combining software and reagents, for the International clinical market. We specialise in the use of cell free DNA to inform clinical decisions with a particular focus on post-treatment cancer surveillance via...

  • Senior Ra Specialist

    3 weeks ago


    Birmingham, United Kingdom Nonacus Limited Full time

    **Senior RA Specialist** **Perm** **Birmingham** Nonacus Ltd, is a privately held company developing innovative molecular diagnostics products, combining software and reagents, for the International clinical market. We specialise in the use of cell free DNA to inform clinical decisions with a particular focus on post-treatment cancer surveillance via...