Senior Regulatory Affairs Specialist

  • Arjo
  • Houghton Regis, UK
  • 18 Nov, 2020
Full time Professional Services Public Sector and Government Strategy-Planning

Job Description

With people in mind

Arjo is a globally minded company with a Swedish heritage, where a thriving international environment is driven by Swedish leadership culture. As a company that puts people at the heart of everything we do, Arjo employees are our partners in our mission to improve lives.

Explore challenging and rewarding careers in a wide range of specialties across our global network.

 

 

Position: Senior Regulatory Affairs Specialist
Location: Houghton Regis
Job Type: Permanent
Hours: Monday to Friday 9am – 5pm

 

The Role

An exciting opportunity has arisen for a Senior Regulatory Affairs Specialist to join Arjo at our head office in Houghton Regis to provide accountability and responsibility for the international registrations for Arjo products within a designated region.

 

Key duties include:

  • Prepare product registration documentation for new and amended product licences for medical devices
  • Perform impact assessments on product design, engineering change and management system planning process outputs and updated standards and regulations and prepare action plans to mitigate identified compliance and business risks
  • Communicate progress of registrations with internal and external stakeholders
  • Liaise with international affiliates, distributors and competent authorities to ensure timely licence approvals
  • Record registration activities on internal tracking databases
  • Prepare briefing summaries and training on regulations, processes and guidelines within area of responsibility
  • Assist in projects within the Regulatory Affairs function
  • Act as internal auditor to established processes and external standards and regulations

 

Knowledge/Skills/Experience:

  • BA or BS Degree is the minimum requirement with a major in a scientific discipline
  • Considerable regulatory experience in the medical device industry and experience in Quality Assurance/Regulatory Affairs desirable
  • Working knowledge of global medical device regulations
  • Must be able to synthesize technical and clinical information to write clear, understandable licence application documents
  • Must be able to render clear and accurate judgements
  • Ability to work well in a cross-functional team
  • Computer knowledge in Microsoft Word, Excel, Access etc
  • Excellent written and verbal communication skills
  • Intercultural skills
  • Ability to work independently in a well-structured and systematic manner

 

ABOUT US:

We are a global medical devices company with operations in over 100 countries. Our product portfolio encompasses specialist medical beds, mattresses, hoists, and DVT prevention equipment. We believe in ensuring the comfort and dignity of patients and residents and providing a safe working environment for caregivers and nurses.

 

In everything we do – we do it with people in mind.

 

A career with us gives you plenty of professional challenges. You will become part of an international company with a strong corporate culture and with ambitious plans for continued growth.

 

Please be aware that by applying for this role you are giving Arjo permission to store your information.