Current jobs related to Staff Regulatory Affairs Specialist - Newcastle upon Tyne, Newcastle upon Tyne - Leica Biosystems

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom RSK Group Full time

    Job DescriptionRSK Group is seeking a highly skilled Senior Regulatory Affairs Consultant to join their regulatory and environmental risk assessment teams based in the UK. The post holder will be supervised by, and accountable to, the Head of Regulatory Affairs.Key Responsibilities:Provide key expertise within regulatory affairs of pesticides and biocides...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom RSK Group Full time

    Job DescriptionRSK Group is seeking a highly skilled Senior Regulatory Affairs Consultant to join their regulatory and environmental risk assessment teams based in the UK. The post holder will be supervised by, and accountable to, the Head of Regulatory Affairs.Key Responsibilities:Provide key expertise within regulatory affairs of pesticides and biocides...

  • Global Head of Regulatory Affairs

    5 days ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northreach Full time

    Global Head of Regulatory AffairsNorthreach is partnering with a leading pharma company in the UK to find a talented Global Head of Regulatory Affairs to lead their regulatory team.Key Responsibilities:Develop and Implement Regulatory Strategies: Manage local regulatory partners and ensure robust data management systems are in place.Lead Regulatory Planning:...

  • Global Head of Regulatory Affairs

    5 days ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northreach Full time

    Global Head of Regulatory AffairsNorthreach is partnering with a leading pharma company in the UK to find a talented Global Head of Regulatory Affairs to lead their regulatory team.Key Responsibilities:Develop and Implement Regulatory Strategies: Manage local regulatory partners and ensure robust data management systems are in place.Lead Regulatory Planning:...

  • Global Head of Regulatory Affairs

    5 days ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northreach Full time

    Global Head of Regulatory AffairsNorthreach is partnering with a leading pharma company in the UK to find a talented Global Head of Regulatory Affairs to lead their regulatory team.Key Responsibilities:Develop and Implement Regulatory Strategies: Manage local regulatory partners and ensure robust data management systems are in place.Lead Regulatory Planning:...

  • Global Head of Regulatory Affairs

    5 days ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northreach Full time

    Global Head of Regulatory AffairsNorthreach is partnering with a leading pharma company in the UK to find a talented Global Head of Regulatory Affairs to lead their regulatory team.Key Responsibilities:Develop and Implement Regulatory Strategies: Manage local regulatory partners and ensure robust data management systems are in place.Lead Regulatory Planning:...

  • Chemical Regulatory Expert

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom RSK Group Full time

    Job DescriptionRSK Group is seeking a highly skilled Senior Regulatory Affairs Consultant to join their regulatory and environmental risk assessment teams based in the UK. The successful candidate will be supervised by, and accountable to, the Head of Regulatory Affairs.Key Responsibilities:Provide key expertise within regulatory affairs of pesticides and...

  • Chemical Regulatory Expert

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom RSK Group Full time

    Job DescriptionRSK Group is seeking a highly skilled Senior Regulatory Affairs Consultant to join their regulatory and environmental risk assessment teams based in the UK. The successful candidate will be supervised by, and accountable to, the Head of Regulatory Affairs.Key Responsibilities:Provide key expertise within regulatory affairs of pesticides and...

  • Regulatory Policy Specialist

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Willow Resourcing Limited Full time

    Job SummaryWe are seeking a highly skilled Regulatory Policy Specialist to join our team at Willow Resourcing Limited. As a key member of our team, you will be responsible for developing and implementing regulatory policies and guidelines that ensure our clients receive the best possible advice and service.Key ResponsibilitiesDevelop and maintain regulatory...

  • Regulatory Policy Specialist

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Willow Resourcing Limited Full time

    Job SummaryWe are seeking a highly skilled Regulatory Policy Specialist to join our team at Willow Resourcing Limited. As a key member of our team, you will be responsible for developing and implementing regulatory policies and guidelines that ensure our clients receive the best possible advice and service.Key ResponsibilitiesDevelop and maintain regulatory...

  • Customer Service Regulatory Specialist

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CBSbutler Full time

    Job OverviewCBSbutler is seeking a highly skilled Customer Service Regulatory Specialist to join our team in a 6-month contract position. As a key member of our contact centre, you will be responsible for handling customer complaints and ensuring that all interactions meet regulatory obligations.This is an excellent opportunity for a motivated individual to...

  • Litigation and Regulatory Expert

    2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Thompsons Solicitors Full time

    Job SummaryWe are seeking a highly skilled and experienced Professional Misconduct Specialist Lawyer to join our team at Thompsons Solicitors. As a key member of our litigation and regulatory team, you will be responsible for managing a varied caseload of litigated and non-litigated professional misconduct cases.Key ResponsibilitiesManage a diverse portfolio...

  • Litigation and Regulatory Expert

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Thompsons Solicitors Full time

    Job SummaryWe are seeking a highly skilled and experienced Professional Misconduct Specialist Lawyer to join our team at Thompsons Solicitors. As a key member of our litigation and regulatory team, you will be responsible for managing a varied caseload of litigated and non-litigated professional misconduct cases.Key ResponsibilitiesManage a diverse portfolio...

  • Regulatory Compliance Specialist

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Adroit People Full time

    Job Summary:We are seeking a highly skilled Regulatory Analyst to join our team at Adroit People. As a Regulatory Analyst, you will play a critical role in ensuring that our company meets all regulatory requirements and obligations.Key Responsibilities:Customer Interaction: Provide excellent service to customers, ensuring that their interactions meet our...

  • Regulatory Compliance Specialist

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Russell Tobin Full time

    Job SummaryRussell Tobin is seeking a highly skilled Regulatory Agent to join our team in Newcastle Upon Tyne. As a Regulatory Agent, you will play a crucial role in ensuring our client's compliance with Financial Conduct Authority (FCA) regulations.Key ResponsibilitiesMonitor customer calls and assess them against agreed criteria to ensure compliance with...

  • Regulatory Compliance Specialist

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Russell Tobin Full time

    Job SummaryRussell Tobin is seeking a highly skilled Regulatory Agent to join our team in Newcastle Upon Tyne. As a Regulatory Agent, you will play a crucial role in ensuring our client's compliance with Financial Conduct Authority (FCA) regulations.Key ResponsibilitiesMonitor customer calls and assess them against agreed criteria to ensure compliance with...

  • Regulatory Compliance Specialist

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Russell Tobin Full time

    Job DescriptionAbout the RoleWe are seeking a highly skilled Regulatory Agent to join our team at Russell Tobin. As a Regulatory Agent, you will play a crucial role in ensuring our client's compliance with Financial Conduct Authority (FCA) regulations, particularly in complaint handling and customer outcome testing.Key ResponsibilitiesMonitor customer calls...

  • Regulatory Compliance Specialist

    3 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Russell Tobin Full time

    Job DescriptionAbout the RoleWe are seeking a highly skilled Regulatory Agent to join our team at Russell Tobin. As a Regulatory Agent, you will play a crucial role in ensuring our client's compliance with Financial Conduct Authority (FCA) regulations, particularly in complaint handling and customer outcome testing.Key ResponsibilitiesMonitor customer calls...

  • Security Incident Response Officer

    20 hours ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Department for Environment, Food and Rural Affairs... Full time

    Job Title: Security Incident Response OfficerThe Department for Environment, Food and Rural Affairs (Defra) is seeking a highly skilled Security Incident Response Officer to join its team. As a key member of the Security Incident Response Management Team, you will play a critical role in ensuring the security and integrity of Defra's information and...

  • Security Incident Response Officer

    18 hours ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Department for Environment, Food and Rural Affairs... Full time

    Job Title: Security Incident Response OfficerThe Department for Environment, Food and Rural Affairs (Defra) is seeking a highly skilled Security Incident Response Officer to join its team. As a key member of the Security Incident Response Management Team, you will play a critical role in ensuring the security and integrity of Defra's information and...

Staff Regulatory Affairs Specialist

3 months ago

Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Leica Biosystems Full time
Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you're helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.


The
Staff Regulatory Affairs Specialist for Leica Biosystems is responsible for serving as Regulatory Affairs representative on new product development teams and external partnership programs.


This position is part of the Global Regulatory Affairs team and will be fully remote, working with teams based in the UK and the US East Coast.

At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will be a part of the global Regulatory Affairs and report to the Director of Global Regulatory Affairs. You will be responsible for strategy and delivery of Regulatory Affairs for IVD and Companion Diagnostics New Product Development.

If you thrive in a collaborative, fast paced role and want to work to build a world-class IVD Regulatory Affairs organization—read on.


In this role, you will have the opportunity to:

  • Collaborate globally and cross-functionally (e.g., Global Clinical Affairs, Business Development, Quality Assurance, Research & Development, Product/Program Management) to define regulatory strategy and plans for clearance / approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD and Companion Diagnostics markets.
  • Align with external partners and stakeholders on study designs, submissions etc., and participate in relevant meetings.
  • Author and maintain regulatory submissions including defining the global regulatory requirements, creating standard work and action plans, optimizing timelines, articulating submission content and format and developing countermeasures as plans evolve.

The essential requirements of the job include:

  • Bachelor's degree in science or engineering and/or equivalent long-standing experience.
  • Must have requisite training in IVD or medical device Regulatory Affairs through onthejob training, seminars, or certification.
  • Progressive experience in support of New Product Development for high complexity products.
  • Proven experience with regulatory strategy and submissions for highcomplexity diagnostic products in a global market, such as 510(k)s or PMAs in the USA and IVDR in Europe
  • Experience in the IVD, Companion Diagnostics fields strongly preferred.

It would be a plus if you also possess previous experience in:

  • Supporting clinical trials
At Leica Biosystems we believe in designing a better, more sustainable workforce.

We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.

This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.


When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win.

As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful
Danaher Business System tools and the stability of a tested organization.


At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.

Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you've ever wondered what's within you, there's no better time to find out.