Challenge The Future With Us – Join Our Global Team

H&T Presspart is part of the Heitkamp & Thumann Group. The family owned group comprises more than 20 small and medium-sized enterprises located in 9 different countries and employing 2000 people. H&T Presspart is a global leader in the manufacture and supply of respiratory drug delivery components including metered-dose inhaler cans and actuators for the pharmaceutical market. Find out more about working at H&T Presspart at www.presspart.com

For H&T PRESSPART we are searching for a:

Regulatory Affairs Specialist

                       located at Blackburn (UK), Marsberg (GER), Tarragona (ESP) or  Nidau (CH)

Regulatory Affairs Specialist

Your Key Responsibilities:

Reporting to the Director Global QA&RA, to help build and sustain QA&RA systems and processes, by:

  • Supporting the existing team to ensure administration of all aspects of Regulatory Affairs.
  • Auditing of ISO 13485 and ISO 15378 within the organization and associated supply chain partners where appropriate.
  • Maintenance of Drug Master Files (DMF), Annual reports and updates as appropriate in addition to all Product Approvals and CE Declarations.
  • To maintain an independent perspective on Product Approval and Manufacturing Production Processes and Product Performance
  • To ensure the monitoring and reporting of Product Performance and Post Sales Management
  • Regulatory management of customer complaints and Corrective and Preventive Action Management

Key capabilities:

  • Knowledge of EU/2017/745, 90/385/EEC, 93/42/EEC, 89/79/EC and related ISO 13485 and ISO 15378.
  • Knowledge of UK Legislation and UKCA Marking Requirements.
  • Knowledge of Business management, Change Management and Improvement Methodologies.
  • Ability to work flexibly in a fast-paced and challenging environment is essential to add value to the organisation
  • Ability to work Independently and maintain independent view point.
  • Exhibits Coaching, Teamwork and Tenacity
  • Ability to travel to Sites and Suppliers
  • Proficiency in Microsoft Office (Word, Excel and PowerPoint)

We are offering:

  • Independent and challenging tasks with a high degree of self-responsibility
  • The opportunity to participate in the success of a leading global manufacturer of precision components with a dedicated and experienced team

You are interested?

Please forward your application to

Thomas Mitchell

Director, Global Quality Assurance and Regulatory Affairs

E- Mail: thomas.mitchell@presspart.com