Regulatory Affairs and Quality Assurance Specialist

4 weeks ago


Cambridge, Cambridgeshire, United Kingdom Hologic, Inc. Full time

At Hologic, Inc., we are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team. As a leading innovator of women's health, we empower people to live healthier lives everywhere, every day.

Our quality and regulatory affairs team is responsible for staying up-to-date on new, changing, and existing regulatory requirements. They develop and implement a global vision for regulatory affairs, government relations, quality management, and market access, influencing strategic and operational plans.

As our Quality Assurance and Regulatory Affairs Specialist, you will provide support to acquired company sites for on-market medical devices remediation and support. You will facilitate reviews of QMS systems with a risk-based approach and prepare for harmonization, enabling you to offer support and guidance to action items within the Integrated Quality Plan.

  1. Assess change requests of products for impact to design, determine supporting information required for implementation of changes.
  2. Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, biocompatibility, sterility, and conformance to product requirements.
  3. Review risk documentation for adequacy and update risk files into the Hologic templates.
  4. Work collaboratively with R&D to coordinate design elements of Risk Management files for products to assure compliance with applicable standards and internal procedures/policies.
  5. Ensure the accuracy of data collected and thorough investigation of complaints.
  6. Work closely with R&D, Manufacturing, Service, and Supplier Quality to ensure thorough and accurate investigations and drive the initiation of CAPAs when appropriate.
  7. Assist with quick and effective resolution to quality issues, including ship hold and field actions.
  8. Assist with managing field actions, including regulatory and field communication, and execution of deliverables.

What We Expect

  1. Expertise: Bachelor's Degree, preferably in an engineering/scientific discipline, biomechanical, biomedical, mechanical, electrical engineering.
  2. Knowledge: MDSAP, EU Medical Device Regulation, US/EU Medical Device Reporting and Vigilance.
  3. Skill: Strong analytical skills, including trend and statistical analysis, interpersonal, and management skills.
  4. Experience: A significant and demonstrable track record of managing projects in a medical device, pharmaceutical, or heavily regulated industry.
  5. Continuous Learning: A commitment to ongoing professional development and staying abreast of industry trends and advancements.

We are committed to making Hologic, Inc. the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. Our talent partners can discuss our salary offering and any relevant bonus schemes with you. This is a 12M Fixed Term Contract Position.



  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices recruitment team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation of new products...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Title: Regulatory Affairs and Quality Assurance SpecialistJob Description:We are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our medical devices team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Title: Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation of new products and the...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Professional to join our team at Newton Colmore Consulting Ltd. As a key member of our medical devices recruitment team, you will be responsible for providing quality assurance and regulatory affairs advice to our clients.The ideal candidate will have a strong background...


  • Cambridge, Cambridgeshire, United Kingdom Reed Engineering Full time

    Job Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to lead our quality and regulatory projects and functions.Key Responsibilities:* Implement, maintain, and improve a comprehensive Quality Management System in accordance with relevant quality standards* Stay updated on global regulatory...


  • Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time

    Job SummaryWe are seeking a skilled Regulatory Affairs Specialist to join our team at Vectura Group. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with global regulations and guidelines for medical devices and drug-device combination products.Key Responsibilities:Lead regulatory activities across...


  • Cambridge, Cambridgeshire, United Kingdom Reed Engineering Full time

    Job Title: Regulatory Affairs DirectorJob Summary:Reed Engineering is seeking a highly experienced Regulatory Affairs Director to lead our quality and regulatory projects and functions. The ideal candidate will maintain and improve robust quality management systems and ensure adherence to regulatory requirements throughout the development lifecycle of our...


  • Cambridge, Cambridgeshire, United Kingdom VCLS Full time

    VCLS is seeking a highly skilled Regulatory Affairs Specialist to drive forward regulatory processes, ensure compliance, and contribute to innovative clinical trials. The ideal candidate will have 4+ years of experience in Regulatory Affairs, with a focus on Clinical Trial Submissions (CTS). They will possess a deep understanding of regional and local...


  • Cambridge, Cambridgeshire, United Kingdom VCLS Full time

    Regulatory Affairs SpecialistWe are expanding our Clinical Trial Submissions (CTS) group and are seeking an experienced Regulatory Affairs professional to join our team. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions. You'll have the opportunity to work under a generous,...


  • Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with UK and EU regulations.Key ResponsibilitiesProvide guidance and support to clients on...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Assurance Specialist, you will be responsible for assisting in the development of the QMS system for ISO 13485 standards.Key Responsibilities:Creating and managing technical files...


  • Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time

    Regulatory LeadershipVectura Group, a global leader in inhaled therapies and drug-device combination products, seeks a seasoned Regulatory Affairs Manager to drive the success of our medical device and DDCP regulatory activities.Regulatory Expertise: Lead regulatory activities across Vectura Group, specializing in medical devices and DDCPs, to support...


  • Cambridge, Cambridgeshire, United Kingdom Reed Engineering Full time

    Reed Scientific, a leading partner in the biotech industry, is seeking an experienced Regulatory Affairs Specialist to join their team. This exciting opportunity will see you play a crucial role in ensuring the quality and regulatory compliance of innovative medical devices.  About the Role:This key position will require you to maintain and improve robust...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    We are seeking an experienced Regulatory Affairs Specialist to join our team at Vertex Ventures HC. In this role, you will play a critical part in ensuring the regulatory compliance of our cancer therapies.As a key member of our Regulatory Affairs team, you will be responsible for developing and executing global regulatory strategies for assigned programs or...


  • Cambridge, Cambridgeshire, United Kingdom https:jobs-redefined.cositemap Full time

    Senior Regulatory Scientist (Clinical Trial Submissions)We are expanding our Clinical Trial Submissions (CTS) group and are seeking an experienced Regulatory Affairs professional to support our team. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.As part of a supportive...


  • Cambridge, Cambridgeshire, United Kingdom VCLS Full time

    Role Overview:We are seeking a highly skilled Regulatory Affairs professional to join our Clinical Trial Submissions (CTS) group at VCLS. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.As part of a supportive and collaborative team, you'll play a key role in driving...


  • Cambridge, Cambridgeshire, United Kingdom Philips International Full time

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Philips International. In this role, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for US, EU, and RoW.Your Key Responsibilities:Develop and execute...


  • Cambridge, Cambridgeshire, United Kingdom CTI Clinical Trial and Consulting Services Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at CTI Clinical Trial and Consulting Services. As an Associate Director, Regulatory Affairs, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s).Key Responsibilities:Develop and...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job OverviewWe are seeking a highly skilled Senior Associate, Regulatory Affairs to join our team at Bicycle Therapeutics. As a key member of our regulatory affairs department, you will be responsible for the development, execution, and tracking of global regulatory submissions for assigned programs or projects.


  • Cambridge, Cambridgeshire, United Kingdom VCLS Full time

    Role Overview:We are seeking an experienced Regulatory Affairs professional to join our Clinical Trial Submissions (CTS) group. As a key member of our team, you will play a pivotal role in driving forward regulatory processes, ensuring compliance, and contributing to innovative clinical trials.Key Responsibilities:Identify and coordinate international,...