Hobson Prior are working with a leading pharmaceutical company who specialise in developing pioneering products for the treatment of structural heart disease. As the Regulatory Affairs Specialist you will ensure the compliance of the risk management process according to ISO 14971 and the organisations quality management system.

Job Responsibilities:

• Maintains, reviews and approves risk management documentation and coordinates technical experts.
• Deploy risk management best practice, standard operating procedures and general guidance for the application of risk management in device development.
• Distributes knowledge and awareness of risk management within the organisation, supports customer complaints and is responsible for the improvement of the risk management.
• Close collaboration with other departments and change management teams to assess risk for the organisations Products and create / update risk management files.
• Co-operate with the complaints department and medical device safety officer to support life cycle management esp. during post-market life cycle phase.
• In control of keeping quality risk management files in alignment with EU MDR, ISO and further applicable regulations.
• Conducting risk assessments for the company's GmbH products and globally in post market lifecycle phase and providing risk reviews.

Key Skills:

• Exceptional knowledge of English.
• Strong social and communication skills.
• A confident user of standard office software.
• Excellent in leadership, communication, organization and time management.

Requirements:

• Technical Scientific Degree (minimum Bachelor of Science).
• You will have a minimum of 1- 2 years' experience in risk management (preferably in the medical device industry).
• Knowledge in medical device regulations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.