Regulatory Affairs and Quality Lead

7 days ago

Crawley, West Sussex, United Kingdom Elekta Full time

Regulatory Affairs & Quality Lead - Region Europe

The Regulatory Affairs & Quality (RAQ) Lead for Region Europe is responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for regulatory submissions and strategies.

Key Responsibilities:

  1. Support, create and maintain the Regional Submission Process(s) and Regulatory Roadmap for European region.
  2. Inform and support local organizations regarding changes in legislation, providing interpretation and strategic advice.
  3. Represent Elekta in international regulatory bodies, hosting external audits with Notified Bodies within the member states of the EU and regulatory authorities within Eastern European region where required.
  4. Support locally appointed regulatory and quality staff in respective areas in their interactions with national authorities and in preparations of submissions and compliance data.

Requirements:

  1. More than 5+ years of experience working with regulatory affairs in European region.
  2. Knowledge and proven track record in Regulatory Affairs for Medical Devices in European region.
  3. Knowledge of the European Directive for Medical Devices & experience of ISO 13485 would be preferred.
  4. Degree equivalent in an engineering related subject or a formal engineering apprenticeship with demonstrated experience in a similar role.

Benefits:

  • Up to 25 paid vacation days (plus bank holidays)
  • Holiday Purchase Scheme
  • Private Medical Insurance
  • Attractive Employer Pension Contribution Package
  • Hybrid work option (you are required to work on location at least 3 days a week)
  • Cycle to work scheme
  • Life Assurance
  • Onsite subsidized restaurant, offering budget-friendly dining
  • Love electric (Electric vehicle salary sacrifice scheme)

  • Regulatory Affairs and Quality Lead

    1 month ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Regulatory Affairs and Quality LeadElekta AB is seeking a highly skilled Regulatory Affairs and Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    1 month ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Regulatory Affairs and Quality LeadElekta AB is seeking a highly skilled Regulatory Affairs and Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    1 month ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Regulatory Affairs and Quality LeadElekta AB is seeking a highly skilled Regulatory Affairs and Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    1 month ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Regulatory Affairs and Quality LeadElekta AB is seeking a highly skilled Regulatory Affairs and Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    2 weeks ago

    Crawley, West Sussex, United Kingdom Manor Royal Business District Full time

    Are you a seasoned professional with a passion for regulatory affairs and quality management? We're seeking a highly skilled Regulatory Affairs and Quality Lead to join our team in the European region.This exciting role involves overseeing and managing functions that support departmental initiatives and directives. You will be responsible for setting...

  • Regulatory Affairs and Quality Lead

    1 month ago

    Crawley, West Sussex, United Kingdom Manor Royal Business District Full time

    Regulatory Affairs & Quality Lead - Region EuropeWe are seeking a highly skilled Regulatory Affairs & Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    1 month ago

    Crawley, West Sussex, United Kingdom Manor Royal Business District Full time

    Regulatory Affairs & Quality Lead - Region EuropeWe are seeking a highly skilled Regulatory Affairs & Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    2 weeks ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Regulatory Affairs and Quality LeadElekta AB is seeking a highly skilled Regulatory Affairs and Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    2 weeks ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Regulatory Affairs and Quality LeadElekta AB is seeking a highly skilled Regulatory Affairs and Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    2 weeks ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Job Title: Regulatory Affairs and Quality LeadJob Summary:The Regulatory Affairs and Quality Lead for Region Europe is responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs and Quality Lead

    3 weeks ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Regulatory Affairs & Quality LeadJob Summary:We are seeking a highly skilled Regulatory Affairs & Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.Key Responsibilities:Set priorities, monitor, and report on budget, planning, logistics, and act as a regional coordinator for regulatory...

  • Regulatory Affairs and Quality Lead

    3 weeks ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Regulatory Affairs & Quality LeadJob Summary:We are seeking a highly skilled Regulatory Affairs & Quality Lead to oversee and manage functions that support departmental initiatives and directives in the European region.Key Responsibilities:Set priorities, monitor, and report on budget, planning, logistics, and act as a regional coordinator for regulatory...

  • Regulatory Affairs and Quality Lead

    3 weeks ago

    Crawley, West Sussex, United Kingdom Elekta Full time

    Job Title: Regulatory Affairs and Quality LeadJob Summary:We are seeking a highly motivated and experienced Regulatory Affairs and Quality Lead to join our team at Elekta. As a key member of our organization, you will be responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves setting...

  • Regulatory Affairs and Quality Lead

    3 weeks ago

    Crawley, West Sussex, United Kingdom Elekta Full time

    Job Title: Regulatory Affairs and Quality LeadJob Summary:We are seeking a highly motivated and experienced Regulatory Affairs and Quality Lead to join our team at Elekta. As a key member of our organization, you will be responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves setting...

  • Regulatory Affairs and Quality Lead

    2 weeks ago

    Crawley, West Sussex, United Kingdom Elekta Full time

    Job Title: Regulatory Affairs and Quality LeadJob Summary:We are seeking a highly motivated and experienced Regulatory Affairs and Quality Lead to join our team at Elekta. As a key member of our European regulatory team, you will be responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves...

  • Regulatory Affairs and Quality Lead

    2 weeks ago

    Crawley, West Sussex, United Kingdom Elekta Full time

    Job Title: Regulatory Affairs and Quality LeadJob Summary:We are seeking a highly motivated and experienced Regulatory Affairs and Quality Lead to join our team at Elekta. As a key member of our European regulatory team, you will be responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves...

  • Regulatory Affairs Lead

    2 months ago

    Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

    About UsWelland Medical Ltd is a leading medical device manufacturer that has been a part of the Clinimed Holdings Limited group since 1982. Our company is built on a tradition of improvement, ethical leadership, and total commitment to quality and safety.We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open...

  • Regulatory Affairs Lead

    2 months ago

    Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

    About UsWelland Medical Ltd is a leading medical device manufacturer that has been a part of the Clinimed Holdings Limited group since 1982. Our company is built on a tradition of improvement, ethical leadership, and total commitment to quality and safety.We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

    About UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We bring to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Our...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

    About UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We bring to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Our...