Current jobs related to Regulatory Affairs Specialist - Bedford - SPD Development Company Limited

  • Regulatory Affairs Specialist

    2 weeks ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging. We are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, with a focus on labeling and promotional communications. The successful candidate will be...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Job Title: Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.About the RoleWe are looking for a highly skilled and motivated individual to lead the development and...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Job Title: Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.About the RoleWe are looking for a highly skilled and motivated individual to lead the development and...

  • Senior Regulatory Affairs Specialist

    5 months ago

    Bedford, United Kingdom SPD Development Company Ltd Full time

    **Senior Regulatory Affairs Specialist** Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between **Procter & Gamble (P&G)** and **Abbott**; and our brand **Clearblue**, is recognised the world over as providing accurate home pregnancy and fertility...

  • Regulatory Affairs Specialist

    4 days ago

    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfen, a global leader in diagnostic instruments, seeks a highly skilled Regulatory Affairs Specialist to join our team. This role will focus on ensuring compliance with regulatory requirements for our medical devices in international markets.Key ResponsibilitiesDevelop and implement regulatory strategies to satisfy NMPA and PMDA...

  • Regulatory Affairs Specialist

    1 month ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.Key Responsibilities:Develop and implement regulatory strategies for advertising and promotional materials,...

  • Regulatory Affairs Specialist

    1 month ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.Key Responsibilities:Develop and implement regulatory strategies for advertising and promotional materials,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Regulatory Affairs team at Werfen, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Regulatory Affairs team at Werfen, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Officer

    4 months ago

    Bedford, United Kingdom SPD Development Company Ltd Full time

    **Regulatory Affairs Officer** Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between **Procter & Gamble (P&G)** and **Abbott**; and our brand **Clearblue**, is recognised the world over as providing accurate home pregnancy and fertility monitoring...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job Summary:We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Werfen. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to...

  • Regulatory Affairs Specialist

    5 months ago

    Bedford, United Kingdom SPD Development Company Ltd Full time

    **Regulatory Affairs Specialist** Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between **Procter & Gamble (P&G)** and **Abbott**; and our brand **Clearblue**, is recognised the world over as providing accurate home pregnancy and fertility monitoring...

  • Regulatory Affairs Specialist

    1 week ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job Summary:Werfen is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to provide guidance on regulatory...

  • Regulatory Affairs Specialist

    1 day ago

    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, reagents, and data management solutions. With a strong focus on innovation and quality, we provide healthcare professionals with valuable and complete solutions to improve hospital efficiency and enhance patient care. Our...

  • Regulatory Affairs Specialist

    4 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    4 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    1 week ago

    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics,...

  • Regulatory Affairs Specialist

    1 month ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role involves developing and implementing regulatory strategies, preparing regulatory plans and submissions, and collaborating with cross-functional teams to ensure regulatory compliance.Key...

Regulatory Affairs Specialist

2 months ago

Bedford, United Kingdom SPD Development Company Limited Full time

Regulatory Affairs Specialist - Innovation

Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between Procter & Gamble (P&G) and Abbott; and our brand Clearblue, is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.

We are looking for a Regulatory Affairs Specialist - Innovation to join our Regulatory Affairs team on a Full-Time, Permanent Contract.

The role will be based at our Innovation Centre in Bedford, UK with option for Hybrid Working.

The Regulatory Affairs Specialist role supports SPDs product portfolio transition from IVDD to IVDR, and also the regulatory strategy and implementation for assigned new product development projects as directed by the Regulatory Affairs Manager - Innovation and the Regulatory Director.

The role fundamentally provides technical regulatory knowledge and guidance on global regulations, specific to In Vitro Diagnostic Medical Devices (IVD) and Medical Devices (MD). As part of this, the role examines new legislation and implements into processes if required, with initial focus on requirements as part of the IVDD to IVDR transition. The role will support new product concept work and business development (third party sourcing) projects. The role holder advises teams on the regulatory environment and requirements associated with the products being investigated but must also be focussed on identifying compliant solutions to regulatory problems that represent the least burdensome route.

We’re looking for someone who holds a minimum of BSc degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.) and has extensive hands on experience in IVD or Medical Device Industry and comprehensive knowledge of ISO 13485, European regulations for medical devices, FDA regulations for medical devices, Canadian Medical Device Regulations and other international standards and regulations for IVD and medical device products. Experience of working with Notified Bodies and regulatory agencies is also essential, and prior experience of working with or within start-up companies is desirable.

The role holder will be expected to represent the company to the highest professional standards so good interpersonal skills and excellent written and oral communication skills are essential along with the ability to communicate complex technical information clearly.

We can offer you:

  • Hybrid working
  • Annual discretionary bonus
  • 25 days paid annual leave plus bank holidays
  • Company pension scheme including competitive employer’s contribution
  • Private Medical Insurance package with additional medical cash plan scheme
  • Enhanced maternity and paternity pay
  • Company supported employee Health & Wellbeing programme
  • Life assurance
  • Free electrical car charging points
  • Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & rail)

If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.

We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.

The Company

SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products.

Our SPD research centre is at the cutting edge of innovation, and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.