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R&D Process Specialist

Gothenburg, SE

Ref. number:  1434

Do you want to have a career where you make a difference and save lives? Do you want to improve healthcare outcomes around the world? We are looking for a driven R&D Process Specialist with an analytical mindset and coaching approach to join our exciting journey.

 

Are you ready for your next challenge?

 

As a R&D Process Specialist you will be responsible for integrity and compliance status of agreed R&D core processes in accordance with external quality and regulatory requirements and with other aspects of the Mölnlycke quality management system. You will work with all aspects of our core R&D processes like Design Control but with a main focus on Risk Management and Usability Engineering for the global R&D community .

 

You will be part of a truly global team where we encourage and listen to each other. In this role you will produce sustainable improvements to our time-to-market and contribute to the company´s growth and strategic goals through stakeholder engagement, people development,  education, coaching, and evolution of defined R&D processes and tools.

 

Your responsibilities

  • Provide strategic guidance for defined R&D processes throughout the product lifecycle.
  • Develop and maintain processes and related QMS documentation for defined R&D processes and provide training to stakeholders.  
  • Support in identifying and evaluating new or changed regulatory requirements related to defined R&D processes, conduct impact assessments, prepare implementation plans as required, including user training.
  • Support in providing an effective continuous training plan and support structure for defined R&D processes.
  • Support in anticipating regulatory/compliance risks related to defined R&D processes and provide solutions for risk mitigation throughout the product lifecycle. .
  • Support in ensuring R&D audit and inspection readiness for defined R&D processes.
  • Support teams in audit and inspection activities.

 

Your qualifications

  • Academic background in Engineering or Life Sciences (Bachelor or Master Degree) or corresponding experience.
  • Minimum 5 years of experience from medical device industry or equivalent.
  • Experience in Design Control related to medical devices (e.g. ISO 13485 / CFR part 820) and Risk Management (e.g. ISO 14971) and Usability Engineering.
  • Leader skills in order to coach and develop the R&D staff in general.
  • Good communication skills..
  • An interest in developing others and driving improvements.
  • Excellent English written and spoken.

 

We look forward to hearing from you. Welcome with your application no later than August 15th.