R&D Process Specialist

Location: Göteborg
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.

If you feel you have the right skills to offer for this position or would be interested in other positions with Molnlycke then please email matt.davitt@molnlycke.com with your CV or apply through LinkedIn https://www.linkedin.com/jobs/view/1959943167/